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Khan, Rana, Aizaz Ahmed Khan, Nuha Rasheed y Abdul Saleem Mohammad. "Current Trends in Radio-Pharmaceuticals". Asian Journal of Pharmacy and Technology 7, n.º 2 (2017): 77. http://dx.doi.org/10.5958/2231-5713.2017.00012.5.
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Carlucci, Giuseppe, Hildo J.K. Ananias, Zilin Yu, Christophe Van de Wiele, Rudi A. Dierckx, Igle J. de Jong y Philip H. Elsinga. "Multimerization Improves Targeting of Peptide Radio-Pharmaceuticals". Current Pharmaceutical Design 18, n.º 17 (1 de abril de 2012): 2501–16. http://dx.doi.org/10.2174/13816128112092501.
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Shahzad, Khurram, Aman Shah Abdul Majid, Mumtaz Khan, Muhammad Adnan Iqbal y Asjad Ali. "Recent advances in the synthesis of (99mTechnetium) based radio-pharmaceuticals". Reviews in Inorganic Chemistry 41, n.º 3 (26 de enero de 2021): 151–98. http://dx.doi.org/10.1515/revic-2020-0021.
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Abstract Technetium radionuclide (99mTc) has excellent extent of disintegration properties and occupies a special place in the field of nuclear medicinal chemistry and other health disciplines. Current review describes recent approaches of synthesis in detailed ways for radio-pharmaceuticals of technetium which have been developed to treat and diagnose the biotic disorders. These technetium labeled radio-pharmaceuticals have been established to apply in the field of diagnostic nuclear medicine especially for imaging of different body parts such as brain, heart, kidney, bones and so on, through single photon emission computed tomography (SPECT) that is thought to be difficult to image such organs by using common X-ray and MRI (Magnetic Resonance Imaging) techniques. This review highlights and accounts an inclusive study on the various synthetic routes of technetium labeled radio-pharmaceuticals using ligands with various donor atoms such as carbon, nitrogen, sulphur, phosphorus etc. These compounds can be utilized as next generation radio-pharmaceuticals.
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Zimmer, Luc. "Pharmacological agonists for more-targeted CNS radio-pharmaceuticals". Oncotarget 7, n.º 49 (16 de noviembre de 2016): 80111–12. http://dx.doi.org/10.18632/oncotarget.13418.
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Theobald, A. "Labelled compounds and radio-pharmaceuticals applied in nuclear medicine". Endeavour 11, n.º 4 (enero de 1987): 220–21. http://dx.doi.org/10.1016/0160-9327(87)90312-7.
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Isabelle, D. B. y J. Vernois. "Labelled compounds and radio-pharmaceuticals applied in nuclear medicine". Biochimie 69, n.º 11-12 (noviembre de 1987): 1263. http://dx.doi.org/10.1016/0300-9084(87)90161-1.
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Ismailani, Uzair S., Maxime Munch, Braeden A. Mair y Benjamin H. Rotstein. "Interrupted aza-Wittig reactions using iminophosphoranes to synthesize 11C–carbonyls". Chemical Communications 57, n.º 43 (2021): 5266–69. http://dx.doi.org/10.1039/d1cc01016f.
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Turck, R. "Radio-pharmaceuticals for cancer treatment: are they ready for prime time yet?" Annals of Oncology 29, n.º 7 (julio de 2018): 1594–97. http://dx.doi.org/10.1093/annonc/mdy142.
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Ludwig, Dale, Ruth Bryan, Wojciech Dawicki, Eileen M. Geoghegan, Qing Liang, Sandesh Seth, Mamata Gokhale et al. "Preclinical Development of an Actinium-225-Labeled Antibody Radio-Conjugate Directed Against CD45 for Targeted Conditioning and Radioimmunotherapy". Blood 134, Supplement_1 (13 de noviembre de 2019): 5601. http://dx.doi.org/10.1182/blood-2019-128678.
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Introduction: Radiolabeled CD45 antibodies have demonstrated clinical promise as targeted conditioning treatments prior to bone marrow transplant (BMT) as a better tolerated and potentially more effective alternative to harsh chemotherapy and/or total body irradiation regimens for myeloablative conditioning. CD45 is expressed on all immune cells, including hematopoietic stem cells and both precursor and mature lymphoid and myeloid cells, with an average copy number up to 200,000 molecules per cell, making it an ideal antigen for directing targeted radiation for conditioning. It is also highly expressed on most lymphomas and leukemias, and approximately 50% of multiple myeloma, further offering the potential for mediating a substantial anti-tumor effect in treated patients. We describe the preclinical development of a novel anti-CD45 antibody radio-conjugate (ARC) that harnesses the power of alpha radiation by arming the pan-CD45 antibody BC8 with Actinium-225 (225Ac). 225Ac is a potent radionuclide with high linear energy transfer (80-100 keV/μm) yet short path length (50-80 μm) to deliver significantly more lethal double strand DNA breaks per alpha track than beta particles. In addition, the use of 225Ac for targeted conditioning has advantages of safe handling and ease of use and a long 10 day half-life that enables flexibility in preparation and use. Methods and Results: To generate 225Ac-BC8, the monoclonal antibody was first conjugated with the DOTA chelator, then labeled with 225Ac, achieving a labeling efficiency typically greater than 80%. 225Ac-BC8 was subsequently purified to high radiochemical purity by column chromatography. Using human CD45+ Ramos lymphoma cell line and EL4 as negative control, 225Ac-BC8 was shown to be stable and retain selective immunoreactivity following conjugation and labeling. To evaluate the anti-tumor potency of 225Ac-BC8, two CD45+ human multiple myeloma (MM) cell lines with high or low relative CD45 antigen density, U266 and H929, respectively, (Collette, et al. 2007) were tested by cell cytotoxicity assay. Following transient exposure (4 or 12 hours) to 225Ac-BC8, the ARC demonstrated potent dose-dependent MM cell killing 72 hours post-treatment, achieving greater than 90% cytotoxicity of both cell lines. To further assess the therapeutic potential of 225Ac-BC8, its anti-tumor activity was tested in subcutaneous (s.c.) xenograft models of H929 and U266. NOD-SCID mice bearing established s.c. tumors were randomized to receive a single dose of 300 nCi of 225Ac-BC8, 300 nCi of an irrelevant radio-conjugate 225Ac-18B7, naked BC8 antibody, or no treatment control. In both models, 225Ac-BC8 exerted complete and durable tumor control for the duration of study. None of the control groups exhibited any anti-tumor effect. Studies to evaluate 225Ac-BC8 in models of CD45+ lymphoma are ongoing. Since BC8 does not cross-react with mouse CD45 and only weakly with macaque CD45, biodistribution, dosimetry and imaging analysis was performed in mice using radio-labeled anti-mouse pan-CD45 surrogate antibody 30F11. SPECT/CT imaging and biodistribution was performed with 111In-labeled 30F11. Following IV administration, 111In-CD45 (30F11) rapidly cleared from the blood and accumulated in immune system organs including spleen, bone marrow, and lymph node. Dosimetry calculations for 225Ac-CD45 (30F11) were determined for absorbed dose to target organs. Only modest uptake was noted in the kidney, but significant uptake occurred in liver, the major site for catabolism of full-length antibodies. 225Ac-CD45 (30F11) is a useful molecule to study the tolerability and myeloablative properties of 225Ac-CD45 antibody for targeted conditioning prior to donor BMT, using B6-Ly5b donor cells in B6-Ly5a mice. Results of ongoing studies will also be presented. Conclusions: The pan-CD45 antibody BC8 was shown to be efficiently conjugated and labeled with the potent alpha emitter 225Ac to mediate robust and selective killing of CD45+ MM cells and xenografts. Biodistribution analysis confirmed selective uptake into organs of the immune system including homing to BM. Supported by ongoing myeloablative/BM reconstitution studies, these preclinical data support the development of 225Ac-BC8 as a novel potent and safe targeted conditioning approach for BMT. Reference: Collette, et al., (2007). Eur. Cytokine Netw. 18:120-126. Disclosures Ludwig: Actinium Pharmaceuticals: Employment, Equity Ownership. Dawicki:Actinium Pharmaceuticals: Research Funding. Geoghegan:Actinium Pharmaceuticals: Employment. Liang:Actinium Pharmaceuticals: Employment. Seth:Actinium Pharmaceuticals: Employment, Equity Ownership. Gokhale:Actinium Pharmaceuticals: Employment. Berger:Actinium Pharmaceuticals, Inc: Employment, Equity Ownership. Reddy:Actinium Pharmaceuticals: Employment. Dadachova:Actinium Pharmaceuticals: Consultancy, Research Funding; RadImmune Therapeutics: Consultancy, Research Funding.
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Zimmerman, Chris. "Protecting the Pharmaceutical Supply Channel". Journal of Pharmacy Practice 19, n.º 4 (agosto de 2006): 236–38. http://dx.doi.org/10.1177/0897190006293516.
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Protecting and securing the pharmaceutical supply channel requires constant vigilance in cooperation with all partners in the channel: the manufacturer, the distributor, and the pharmacy as well as state and federal legislators and regulatory agencies. No one approach can protect and secure; rather, the pharmaceutical industry as a whole needs to adopt a combination of approaches to ensure the safety and integrity of the supply channel. Right now, the most secure way to ensure product integrity and patient safety is through a primary distribution system, also referred to as normal distribution. Primary distribution involves the movement of pharmaceuticals from the manufacturer to the wholesale distributor to the pharmacy. Going forward, some new technologies offer great promise. The industry needs to address all technology solutions, from secure product packaging to tracking techniques such as tags, holograms, and ultimately radio frequency identification. All of these begin with the manufacturer, require wholesaler involvement, and rely on the pharmacy. The movement of product must be secure and the highest level of vigilance maintained.
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Velikyan, Irina. "(Radio)Theranostic Patient Management in Oncology Exemplified by Neuroendocrine Neoplasms, Prostate Cancer, and Breast Cancer". Pharmaceuticals 13, n.º 3 (5 de marzo de 2020): 39. http://dx.doi.org/10.3390/ph13030039.
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The role of nuclear medicine in the management of oncological patients has expanded during last two decades. The number of radiopharmaceuticals contributing to the realization of theranostics/radiotheranostics in the context of personalized medicine is increasing. This review is focused on the examples of targeted (radio)pharmaceuticals for the imaging and therapy of neuroendocrine neoplasms (NENs), prostate cancer, and breast cancer. These examples strongly demonstrate the tendency of nuclear medicine development towards personalized medicine.
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Marvaso, Giulia, Agnese Barone, Nicola Amodio, Giuseppe Cascini, Valerio Scotti y Cataldo Bianco. "The Current Status of Novel PET Radio-Pharmaceuticals in Radiotherapy Treatment Planning of Glioma". Current Pharmaceutical Biotechnology 14, n.º 13 (junio de 2014): 1099–104. http://dx.doi.org/10.2174/1389201015666140408122318.
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Ramireddy Navya Sri, Kamaraj R y Sonia K. "Regulatory aspects of GMP in accordance with pharmaceutical inspection co-operation scheme". International Journal of Research in Pharmaceutical Sciences 11, SPL4 (21 de diciembre de 2020): 1333–40. http://dx.doi.org/10.26452/ijrps.v11ispl4.4302.
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The PIC/S strives to harmonize inspection procedures all over the world by establishing specific GMP guidelines and supplying inspectors with training opportunities. This is additionally proposed to advance co-operation and systems administration between capable specialists, local and foreign associations, in this manner becoming common confidence. At present, harmonization efforts need to be improved in setting regulatory standards, monitoring and assessing GMP compliance, licensing production sites, retrieving faulty lots, and increasing the sharing of information due to expanded regulatory authorities for globalization. PIC/S provides an appealing and sustainable platform to give a response to globalization’s challenges. PIC/S actively facilitates networking by organizing a PIC/S GMP Forum," which enables non-member, technical and other organizations to meet informally with the PIC/S committee. Co-Operation Scheme for the Pharmaceutical Inspection is available to any systems administration having a practically identical GMP investigation framework. Co-Operation Scheme for the Pharmaceutical Inspection has built an integrated manual on GMP necessities for inspectorates and also for the industries. The primary harmonization device has been the Co-Operation Scheme for the Pharmaceutical Inspection GMP Guide. The last was initially gotten from the WHO Guide to GMP and further created so as to consent to exacting assembling and wellbeing pre-requisites in the Co-Operation Scheme for the Pharmaceutical Inspection nations, to cover new zones (for example, biological and radio-pharmaceuticals) and to adjust to logical and mechanical innovation.
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Wang, Ming-Zhao, Zhao-Xing Meng, Bo-Li Liu, Guan-Liang Cai, Chun-Li Zhang y Xiang-Yun Wang. "Novel tumor chemotherapeutic agents and tumor radio-imaging agents: Potential tumor pharmaceuticals of ternary copper(II) complexes". Inorganic Chemistry Communications 8, n.º 4 (abril de 2005): 368–71. http://dx.doi.org/10.1016/j.inoche.2005.01.023.
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Burda, Anthony M. y Todd Sigg. "Pharmacy Preparedness for Incidents Involving Nuclear, Biological, or Chemical Weapons". Journal of Pharmacy Practice 17, n.º 4 (agosto de 2004): 251–65. http://dx.doi.org/10.1177/0897190004268653.
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Recent worldwide terrorist attacks and hoaxes have heightened awareness that more incidents involving weapons of mass destruction (WMD) may occur in the United States. With federal funding assistance, local domestic preparedness programs have been initiated to train and equip emergency services and emergency department personnel in the management of large numbers of casualties exposed to nuclear, biological, or chemical (NBC) agents. Hospital pharmacies will be required to provide antidotes, antibiotics, antitoxins, and other pharmaceuticals in large amounts and/or have the capability for prompt procurement. Pharmacists should become knowledgeable in drug therapy of NBC threats with respect to nerve agents, cyanide, pulmonary irritants, radio-nucleotides, anthrax, botulism, and other possible WMD.
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Hau, Peter, Didier Frappaz, Elizabeth Hovey, Martin G. McCabe, Kristian W. Pajtler, Benedikt Wiestler, Clemens Seidel et al. "Development of Randomized Trials in Adults with Medulloblastoma—The Example of EORTC 1634-BTG/NOA-23". Cancers 13, n.º 14 (9 de julio de 2021): 3451. http://dx.doi.org/10.3390/cancers13143451.
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Medulloblastoma is a rare brain malignancy. Patients after puberty are rare and bear an intermediate prognosis. Standard treatment consists of maximal resection plus radio-chemotherapy. Treatment toxicity is high and produces disabling long-term side effects. The sonic hedgehog (SHH) subgroup is highly overrepresented in the post-pubertal and adult population and can be targeted by smoothened (SMO) inhibitors. No practice-changing prospective randomized data have been generated in adults. The EORTC 1634-BTG/NOA-23 trial will randomize patients between standard-dose vs. reduced-dosed craniospinal radiotherapy and SHH-subgroup patients between the SMO inhibitor sonidegib (OdomzoTM, Sun Pharmaceuticals Industries, Inc., New York, USA) in addition to standard radio-chemotherapy vs. standard radio-chemotherapy alone to improve outcomes in view of decreased radiotherapy-related toxicity and increased efficacy. We will further investigate tumor tissue, blood, and cerebrospinal fluid as well as magnetic resonance imaging and radiotherapy plans to generate information that helps to further improve treatment outcomes. Given that treatment side effects typically occur late, long-term follow-up will monitor classic side effects of therapy, but also health-related quality of life, cognition, social and professional outcome, and reproduction and fertility. In summary, we will generate unprecedented data that will be translated into treatment changes in post-pubertal patients with medulloblastoma and will help to design future clinical trials.
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Liu, Fei, Caiyun Fan, Jinming Zhang, Wushang Wang y Boli Liu. "99mTc complex conjugated to insulin: CNS radio-pharmaceuticals design based on principles of blood-brain barrier transport vector". Chinese Science Bulletin 50, n.º 20 (octubre de 2005): 2297–301. http://dx.doi.org/10.1007/bf03183738.
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Donini, Oreola, Brynmor A. Watkins, John Palardy, Steven Opal, Stephen Sonis, Michael J. Abrams y John R. North. "Reduced Infection and Mucositis In Chemotherapy-Treated Animals Following Innate Defense Modulation Using a Novel Drug Candidate." Blood 116, n.º 21 (19 de noviembre de 2010): 3781. http://dx.doi.org/10.1182/blood.v116.21.3781.3781.
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Abstract Abstract 3781 Innate Defense Regulators (IDRs) are a novel class of synthetic peptides with no antimicrobial activity that enhance microbial infection control while suppressing inflammation. IDRs bind to an intracellular scaffold protein, p62 or sequestosome-1, selectively modulating protein-protein complex formation and signaling downstream of receptors such as Toll-like receptors, IL-1 receptor and TNF receptor. Treatment of mice with IDRs enhanced their survival in bacterial infection models. The anti-infective effect of IDRs was maintained in animals depleted of neutrophils, but abolished in animals depleted of macrophages/monocytes, indicating an important role for macrophages in IDR mediated host protection at the site of infection. IDRs have been shown to transiently increase local chemokine levels (CCL5 and CXCL10), enhance macrophage recruitment to the site of infection and improve the resolution of bacterial infection alone or in conjunction with antibiotics. Recently, the enhanced survival benefit conferred by IDR treatment has been shown in clinically-relevant rat models of neutropenic sepsis after cyclophosphamide treatment. In rats pre-treated with cefamandole, made neutropenic with cyclophosphamide and orally colonized with Pseudomonas aeruginosa, administration of IMX942, the lead clinical candidate in the IDR family, once on day 5 (10mg/kg IV) after the development of fever increased survival from 0% (saline group) to 63%. This increased survival was comparable to the antibiotic treated group (75%) and both the antibiotic and IMX942 treated arms demonstrated marked preservation of the mucosal lining in the ileum. Further investigations in an animal model of mucositis, where pathogenesis is linked to the reaction of the innate defense system, have demonstrated that IDRs have significant efficacy in both oral and gut mucositis. In these studies, C3H/HeN mice are administered 5FU (60mg/kg, intraperitoneal injection) on days -4 and -2, and mucositis is induced on day 0 through the application of a chemical burn on the ventral surface of the tongue. Mucositis is then monitored for 14 days, generally peaking on day 2 or 3. Treatment with IMX942 (25mg/kg, IV) on days -1, 2 and 5 or days 0, 2, and 4 resulted in a statistically significant decrease in the duration and severity of oral mucositis (50% reduction) between days 2 and 14, and in the severity of gut mucositis (63% reduction) as measured by clinical endoscopy on day 4. IMX942 has successfully completed Phase 1 clinical studies, and was very well tolerated at single doses up to 8 mg/kg and at multiple doses (7 daily injections) up to 6.5 mg/kg/day. Phase 2 studies evaluating the efficacy of IMX942 in the amelioration of mucositis and infection in cancer patients undergoing radio- or chemo-therapy are currently being planned. Disclosures: Donini: Inimex Pharmaceuticals Inc.: Employment. Watkins:Inimex Pharmaceuticals Inc.: Consultancy. Palardy:Inimex Pharmaceuticals Inc.: Research Funding. Opal:Inimex Pharmaceuticals Inc.: Research Funding. Sonis:Inimex Pharmaceuticals Inc.: Consultancy; Biomodels, LLC: Equity Ownership; SciClione Pharmaceuticals: Consultancy, Membership on an entity's Board of Directors or advisory committees; Novartis: Consultancy; Biovitrum: Consultancy; Johnson and Johnson: Consultancy; Clinical Assistance Programs: Consultancy; Pfizer: Consultancy; Merck: Consultancy. Abrams:Inimex Pharmaceuticals Inc.: Employment. North:Inimex Pharmaceuticals Inc.: Employment.
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Müller, Cristina, Renáta Farkas, Francesca Borgna, Raffaella M. Schmid, Martina Benešová y Roger Schibli. "Synthesis, Radiolabeling, and Characterization of Plasma Protein-Binding Ligands: Potential Tools for Modulation of the Pharmacokinetic Properties of (Radio)Pharmaceuticals". Bioconjugate Chemistry 28, n.º 9 (12 de septiembre de 2017): 2372–83. http://dx.doi.org/10.1021/acs.bioconjchem.7b00378.
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Mignani, Serge, Xiangyang Shi, Valentin Ceña, João Rodrigues, Helena Tomas y Jean-Pierre Majoral. "Engineered non-invasive functionalized dendrimer/dendron-entrapped/complexed gold nanoparticles as a novel class of theranostic (radio)pharmaceuticals in cancer therapy". Journal of Controlled Release 332 (abril de 2021): 346–66. http://dx.doi.org/10.1016/j.jconrel.2021.03.003.
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Veilleux, Jacob, Daniel Steven Dombrowski, Matthew C. Allender y Gregory Lewbart. "Diagnosis, treatment and post-release monitoring of an eastern black rat snake (Pantherophis alleghaniensis) with ophidiomycosis and traumatic injuries". Veterinary Record Case Reports 8, n.º 2 (abril de 2020): e000954. http://dx.doi.org/10.1136/vetreccr-2019-000954.
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Ophidiomycosis, historically known as snake fungal disease, is caused by Ophidiomyces ophiodiicola and has been reported in over 30 species of snakes. In July 2015, an adult female eastern black rat snake (Pantherophis alleghaniensis) was found at Prairie Ridge EcoStation, a North Carolina Museum of Natural Sciences (NCMNS) field site in Raleigh, NC, with traumatic lesions consistent with injuries caused by landscaping equipment. The snake was brought to NCMNS Veterinary Services and tested positive via dermal swabs for O ophiodiicola on quantitative PCR (qPCR). The snake was treated with terbinafine (Terbinafine, 250 mg; InvaGen Pharmaceuticals, Hauppauge, NY, USA) nebulised at 2 mg/ml for 30 min every 24 hours for 30 days, and tested negative on further swabs for O ophiodiicola on qPCR before release. From April 2016 to November 2018, the snake was tracked via radio telemetry with physical examinations, bloodwork and qPCR swabs conducted multiple times a year.
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Nath, Rajneesh, Eileen M. Geoghegan, Matthew L. Ulrickson, Jennifer A. Spross, Renee H. Lichtenstein, Sandy Konerth, Darrell R. Fisher et al. "Sierra Clinical Trial Dosimetry Results Support Low Dose Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] for Targeted Lymphodepletion Prior to Adoptive Cell Therapy". Blood 134, Supplement_1 (13 de noviembre de 2019): 1958. http://dx.doi.org/10.1182/blood-2019-128838.
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Introduction Nearly all adoptive cell therapies currently being evaluated in the clinic, including CAR-T, TIL, and TCR-based cell therapies, require lymphodepletion to remove cellular cytokine sinks and create a favorable cytokine environment for the incoming transferred cells to proliferate. Targeted conditioning with an antibody radio-conjugate directed to CD45 represents a promising and potentially more effective alternative to the commonly used fludarabine/cyclophosphamide chemotherapy lymphodepletion regimen. Methods SIERRA is an ongoing Phase 3 multicenter trial evaluating anti-CD45 Iodine (131I) Apamistamab [Iomab-B] as targeted conditioning prior to HCT in active, relapsed or refractory acute myeloid leukemia. Prior to administration of the therapeutic dosage, dosimetry is performed using a tracer amount of Iomab-B (range from 7-20 mCi, median 10 mCi) in an out-patient setting to calculate the appropriate patient-specific therapeutic infusion. Blood sample analysis from 57 evaluable Iomab-B treated patients collected pre-dosimetric infusion (Pre-DI), post-dosimetric infusion (Post-DI), day 1 post-dosimetric infusion (D1 post-DI), and pre-therapeutic infusion (Pre-TI, range 6-14 days post-dosimetry) was assessed to determine if residual Iomab-B had any significant effect on blood counts in support of its use as a transient targeted lymphodepletion agent. Results From these data, a significant but transient decrease in lymphocytes and white blood cells was observed compared to pre-DI values. An 85% decrease of lymphocytes was observed at the post-DI time point, a 67% decrease at day 1 post-DI, and a 43% decrease at the time of therapeutic infusion. Peripheral blasts were also transiently decreased at the post-DI time point (35%), indicating that low dose Iomab-B may exert an anti-tumor effect in these patients. Interestingly, the levels of platelets, hematocrit, and neutrophils were unchanged at the Pre-TI time point compared to Pre-DI, reflecting the comparatively lower surface antigen levels of CD45 on these cell types. In addition, data from a subset of treated patients (n=25) was used to calculate the radiation absorbed dose to bone marrow to determine an appropriate amount of Iomab-B that would not impart more than 2 Gy, a threshold that is considered to be non-myeloablative. This analysis determined that 75 mCi Iomab-B could be administered as a non-myeloablative amount and has been proposed as the starting dose for a clinical trial using Iomab-B for targeted lymphodepletion prior to CAR-T. Additional calculations were performed to model the clearance of Iomab-B to determine at what time post-infusion a CAR-T could be administered without the amount of residual radiation to bone marrow exceeding a safe level (0.25 Gy). Based on clinical data from the SIERRA trial, the average effective half-time of Iomab-B was 45.1 hours and the time frame for CAR-T administration following 75 mCi of Iomab-B was 136 hours (5.7 days). Given that administration of radiopharmaceuticals often requires special safety precautions, the proposed range of doses for Iomab-B is considered an outpatient infusion without the need for isolation. Conclusions Despite the importance of lymphodepletion prior to adoptive cell therapies, there has been very little optimization of this step. Clinical data collected using a low dose of Iomab-B for dosimetry has demonstrated that this method of lymphodepletion is specifically targeted to CD45+ immune cells, may have an anti-tumor effect, and can be administered in an outpatient setting. These clinical and logistical attributes are attractive characteristics for lymphodepletion and supportive of using Iomab-B as a novel lymphodepletion regimen prior to adoptive cell therapies such as CAR-T. Table Disclosures Nath: Astellas: Consultancy; Daiichi Sankyo: Consultancy; Actinium: Consultancy. Geoghegan:Actinium Pharmaceuticals: Employment. Spross:Actinium Pharmaceuticals: Employment, Equity Ownership. Lichtenstein:Actinium Pharmaceuticals: Employment, Equity Ownership. Konerth:Versant Medical Physics and Radiation Safety: Consultancy. Fisher:Versant Medical Physics and Radiation Safety: Employment. Liang:Actinium Pharmaceuticals: Employment. Ludwig:Actinium Pharmaceuticals: Employment, Equity Ownership. Reddy:Actinium Pharmaceuticals: Employment. Berger:Actinium Pharmaceuticals, Inc: Employment, Equity Ownership. Gyurkocza:Actinium Pharmaceuticals: Research Funding.
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Hermann, S., M. Schäfers, C. Höltke y A. Faust. "Optical imaging probes and their potential contribution to radiotracer development". Nuklearmedizin 55, n.º 02 (2016): 51–62. http://dx.doi.org/10.1055/s-0037-1616473.
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SummaryOptical imaging has long been considered a method for histological or microscopic investigations. Over the last 15 years, however, this method was applied for preclinical molecular imaging and, just recently, was also able to show its principal potential for clinical applications (e.g. fluorescence-guided surgery). Reviewing the development and preclinical evaluation of new fluorescent dyes and target-specific dye conjugates, these often show characteristic patterns of their routes of excretion and biodistribution, which could also be interesting for the development and optimization of radiopharmaceuticals. Especially ionic charges show a great influence on biodistribution and netcharge and charge-distribution on a conjugate often determines unspecific binding or background signals in liver, kidney or intestine, and other organs.Learning from fluorescent probe behaviour in vivo and translating this knowledge to radio-pharmaceuticals might be useful to further optimize emerging and existing radiopharmaceuticals with respect to their biodistribution and thereby availability for binding to their targets.
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Baratto, Lucia, Hong Song, Heying Duan, Carina Mari Aparici, Guido Davidzon, Farshad Moradi, Sandy Srinivas y Andrei Iagaru. "A prospective study of 68Ga-RM2 PET/MRI in patients with biochemically recurrent prostate cancer and negative conventional imaging." Journal of Clinical Oncology 38, n.º 15_suppl (20 de mayo de 2020): e17536-e17536. http://dx.doi.org/10.1200/jco.2020.38.15_suppl.e17536.
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e17536 Background: 68Ga-RM2 is a synthetic bombesin receptor antagonist targeting gastrin-releasing peptide receptors (GRPr) that are overexpressed in several human tumors, including prostate cancer (PC). Methods: We enrolled 114 men with BCR PC, 45-83-year-old (mean±SD: 68.2±7.0). Imaging started at 40-89 minutes (mean±SD: 51.3±9.2 after injection of 113.8-152.6 MBq (mean±SD: 140.7±6.4) of 68Ga-RM2 using a time-of-flight (TOF)-enabled simultaneous positron emission tomography (PET) / magnetic resonance imaging (MRI) scanner. Twenty-four and 23 patients also underwent 68Ga-PSMA11 and 18F-DCFPyL PET/CT, respectively. Results: All patients had rising PSA and negative conventional imaging prior to enrollment. 68Ga-RM2 PET identified recurrent PC in 78 of the 114 participants, while the simultaneous MRI was positive for PC in 45 of the 103 patients. Positivity rate of 68Ga-RM2 PET was: 31.8% for PSA < 0.5 ng/dl ( n= 22), 60% for PSA 0.5 – 1.0 ng/dl ( n= 15), 64.7% for PSA 1.0 – 2.0 ng/dl ( n= 17), 81.8% for PSA 2.0 – 5.0 ng/dl ( n= 22) and 87.2% for PSA > 5.0 ng/dl ( n= 38). PSA velocity values were 1.9±2.7 ng/ml/year (range: 0-9.1) in patients with negative PET scans and 5.8±9 ng/ml/year (range: 0.2-45.4) in patients with positive PET scans ( P: 0.01). Twenty-eight and 34 lesions were detected by 68Ga-RM2 PET and 68Ga-PSMA11 PET, respectively, while 25 lesions in 13 patients were identified by both radio-pharmaceuticals. The mean SUVmax ranged 1.6-51.2 (mean±SD:14.7±12.5) for PSMA and ranged 2.5-52.5 (mean±SD: 10.7±11.6) for RM2 ( P= 0.096). Three lesions in 2 patients were RM2-avid only (all lymph nodes) and 9 lesions in 7 patients were PSMA avid only (7 lymph nodes, 1 skeletal and 1 lung nodule). 32 and 48 lesions were detected by 68Ga-RM2 PET and 18F-DCFPyL PET, respectively. 28 lesions in 12 patients were identified by both radio-pharmaceuticals. The mean SUVmax ranged 1.7-79.3 (mean±SD: 22.2±23) for DCFPyL and ranged 1.7-46.8 (mean±SD: 7±9.2) for RM2 (P < 0.01). Four lesions in 2 patients were RM2 avid only (1 adrenal and 3 skeletal); 17 lesions in 6 patients were DCFPyL avid only (7 lymph nodes, 9 skeletal and 1 prostate). Conclusions: 68Ga-RM2 may identify higher risk patients given the highly statistically significant difference PSA velocity values between patients with negative and positive scans and may be a complementary radiopharmaceutical to the PSMA-targeting tracers to ultimately allow for personalized medicine. Clinical trial information: NCT02624518 .
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Chakravarty, Rubel, Rakesh Shukla, Shyamla Gandhi, Ramu Ram, Ashutosh Dash, Meera Venkatesh y A. K. Tyagi. "Polymer Embedded Nanocrystalline Titania Sorbent for 99Mo-99mTc Generator". Journal of Nanoscience and Nanotechnology 8, n.º 9 (1 de septiembre de 2008): 4447–52. http://dx.doi.org/10.1166/jnn.2008.280.
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A new sorbent material, polymer embedded nano crystalline titania (Titanium Polymer-TiP) has been developed, from titanium (IV) chloride and isopropyl alcohol, for the adsorption of 99Mo, which is a precursor to 99mTc, a workhorse in radio-pharmaceuticals. The infrared absorption spectra of the TiP showed peaks corresponding to Ti-O groups. X-ray diffraction pattern of the adsorbent corresponded to rutile TiO2. The surface area of this polymer was 30 m2/g with an average pore size of 40 nm. The average crystallite size of TiO2, embedded in polymer, was found to be 5 nm. TEM micrograph of the adsorbent revealed the networkof polymer with dispersed titania phase. Potential of this adsorbent for the preparation of 99Mo-99mTc generator has been explored. 99Mo could be adsorbed on to the adsorbent column containing TiP at pH 1 from which 99mTc could be eluted with normal (0.9%) saline solution with an elution yield of ∼80%. The quality of the 99mTcO−4 obtained was in accordance with the international specifications applicable for radiopharmaceutical use. A process demonstration run was carried out with 1.1 GBq (30 mCi) 99Mo activity level making use of the above adsorbent and consistent results were obtained over a period of one week, which is generally the shelf life of 99Mo-99mTc generator.
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Román González, Alejandro y Álvaro Sanabria. "Análisis crítico de la literatura. ¿En pacientes adultos con cáncer diferenciado de tiroides y progresión en los últimos 14 meses, el tratamiento con sorafenib comparado con placebo mejora la supervivencia? Estudio DECISION". Revista Colombiana de Endocrinología, Diabetes & Metabolismo 2, n.º 3 (27 de marzo de 2017): 30–34. http://dx.doi.org/10.53853/encr.2.3.93.
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Introducción: El carcinoma de tiroides es el cáncer endocrino más frecuente. Las opciones terapéuticas cuando hay enfermedad progresiva, sintomática y resistente al yodo radioactivo son mínimas y poco efectivas. El sorafenib es una terapia aprobada para estos pacientes con base en los resultados del estudio DECISION. Se hace una revisión crítica acorde con los principios de medicina basada en la evidencia del estudio que llevó a la aprobación de este medicamento.Título del estudio: Sorafenib in radioactive iodine-refractory, locally advanced or metastatic differentiated thyroid cancer: a randomised, double-blind, phase 3 trial. Lancet. 2014;384(9940):319-28 (1)Métodos: Ensayo clínico aleatorizado, financiado por Bayer HealthCare Pharmaceuticals y Onyx Pharmaceuticals, asignación oculta. Pacientes y resultados: 419 pacientes mayores de 18 años con cáncer de tiroides localmente avanzado o cáncer de tiroides diferenciado metastásico refractario a yodo (papilar, folicular, incluyendo el de células de Hürthle y pobremente diferenciado), con progresión en los últimos 14 meses de acuerdo con los criterios de RECIST, al menos una lesión medible por TAC o por RM, ECOG 0–2; con función renal, medular y hepática normal y TSH menor de 0,5 mIU/L. El cáncer de tiroides refractario a yodo se definió como la presencia de al menos una lesión sin captación de yodo o pacientes con tumores yodo captantes y, bien sea, progresión luego de un tratamiento con yodo radioactivo en los últimos 16 meses o progresión luego de dos tratamientos con yodo recibidos con menos de 16 meses de diferencia (la última dosis recibida más de 16 meses antes) o una dosis acumulada de yodo de al menos 22,3 GBq (?600 mCi). Se excluyeron pacientes que habían recibido previamente terapia dirigida, talidomida o quimioterapia para cáncer de tiroides, cirugía previa o trauma en los 30 días previos al inicio del medicamento, antecedente de cáncer de piel, cérvix o vejiga en los últimos cinco años, cáncer indiferenciado de tiroides, úlceras, infección activa o sangrado en los últimos tres meses, historia de hemorragia, infiltración traqueal, bronquial o esofágica; cardiopatía o hipertensión arterial no controlada, infección por VIH o hepatitis, embarazo o lactancia y alergia al sorafenib. Se permitieron dosis bajas de quimioterapia para radiosensibilización. El desenlace primario fue la supervivencia libre de progresión (cada ocho semanas) con criterios RECIST y los secundarios fueron supervivencia global, tiempo para la progresión, tasa de respuesta objetiva (parcial o completa), tasa de control de la enfermedad (parcial, completa o estable ?4 semanas/6 meses) y duración de la respuesta. La supervivencia libre de progresión fue mayor en el grupo de sorafenib que en el grupo de placebo (10,8 meses vs. 5,8 meses, HR 0,59 – IC 95% 0,45-0,76 p<0,0001). El grupo de sorafenib tuvo una mayor tasa de eventos adversos (98,6 vs. 87,6%).Conclusión: Sorafenib mejora significativamente la supervivencia libre de progresión comparado con placebo en pacientes con cáncer de tiroides diferenciado progresivo refractario a yodo radioactivo. La diferencia es pequeña. Los eventos adversos son frecuentes. No se reporta calidad de vida o mejoría sintomática. Esta terapia debe ser usada por personas expertas y debe evaluarse individualmente cada caso, agotando las opciones disponibles para el paciente antes de someterlo a los riegos del tratamiento.Abstract Introduction: Thyroid carcinoma is the most frequent endocrine cancer. There are minimal therapeutic options once the disease is metastatic, progressive, symptomatic and radioactive iodine resistant. Sorafenib is a recent approved therapy for these patients based on the results of the DECISION trial. A critical review of this study is done according to the principles of evidence-based medicine.Title of the study: Sorafenib in radioactive iodine-refractory, locally advanced or metastatic differentiated thyroid cancer: a randomised, double-blind, phase 3 trial. Lancet. 2014;384(9940):319-28(1)Methods: Randomized clinical trial. Financial support was by Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals. Blinded randomization.Patients and results: 419 patients older tan 18 years with locally advanced thyroid carcinoma or well differentiate or poorly differentiate radioactive resistant metastatic thyroid carcinoma (papillary, follicular, Hurthle´s cell carcinoma and poorly differentiate), with progression over previous 14 months according to RECIST, with at least on measurable target lesion by CT or MR imaging, ECOG 0–2; normal kidney, medullar and liver function and TSH less than 0.5 mIU/L. Resistant radio-active iodine thyroid carcinoma was defined as the presence of at least 1 lesion without iodine uptake or patients with iodine uptake and progression over previous 16 months or progression after two cycles of radio-active iodine with less than 16 months of difference (lass cycle should be administered more 16 months before) or an total radioactive iodine of ?600 mCi. Patients who were treated before with target therapy, talidomide or systemic chemotherapy were excluded. Also patients with surgery or trauma 30 days before starting sorafenib, personal history of skin, cervical or bladder cancer, undifferentiated thyroid carcinoma, ulcers, active infection or bleeding in previous three months, bleeding history, tracheal, bronchial or esophageal infiltration, cardiomyopathy, uncontrolled high blood pressure, HIV infection, hepatitis, pregnancy or breast feeding and sorafenib allergy were excluded. Small chemotherapy doses for radio sensitization were allowed. Primary outcome was progression free survival (every 8 weeks) according to RECIST and secondary outcomes was overall survival, time to progression, rate of objective response (partial or complete), rate of disease control (partial, complete or stable) and response duration. Progression free survival was larger in the sorafenib group than in the placebo group (10.8 month vs5.8 months, HR 0.59 – IC 95% 0.45-0.76 p<0.0001). Sorafenib group had a higher side effects frequency (98·6 vs 87·6%). Conclusion: Sorafenib significantly improves progression free survival compared with placebo in patients with radio-active iodine resistant progressive thyroid carcinoma. The difference is small. Side effects are frequent and quality of life and symptomatic improvement are not reported. This therapy must be used by experts and an individual assessment must be done and all available options must be used before consider the use of this treatment.
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Onyemelukwe, Obiageli U. y Bilkisu B. Maiha. "Prevalence of hyperhomocysteinaemia, selected determinants and relation to hypertension severity in Northern-Nigerian hypertensives: the ABU homocysteine survey". Ghana Medical Journal 54, n.º 1 (31 de marzo de 2020): 17–29. http://dx.doi.org/10.4314/gmj.v54i1.4.
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Background: This study aimed at evaluating the prevalence of hyperhomocysteinaemia in Northern-Nigerian hypertensives and its association with hypertension severity and some major determinants as data regarding these are lackingin sub-Saharan Africa.
Method: A Community-based cross-sectional study done on 120 randomly-selected hypertensive patients who responded to an ABU radio frequency modulated invitation for free health-screening at the Ahmadu Bello University (ABU) Medical Centre from January 2016 to June 2016. The percentage of participants with high homocysteine levels, their anthropometric parameters and blood pressures were determined. Plasma homocysteine (hcy) was classified as normal (5-15), moderate (>15-30), intermediate (31-100) and severe (>100) μmol/L. Kruskal-Wallis test was applied and log-transformed homocysteine (Ln10Homocysteine) was correlated with systolic and diastolic blood pressures as well as age, body mass index, fasting blood glucose, glomerular filtration rate, hypertension duration and Ln10folate in males and females using the Pearson’s Correlation analysis.
Results: There were 83(69.2%) females and 37(30.8%) males with Median homocysteine of 20.8 μmol/L and 22.0 μmol/L respectively (p=0.003). Hyperhomocysteinaemia was found in 118(98.3%) hypertensives while 2(1.7%) subjects had normo-homocysteinaemia. Moderate hyperhomocysteinaemia (Median, 20.8 μmol/L) was identified in 105(87.5%) and intermediate (Median, 40 μmol/L) in 13(10.8%) (p<0.001). No subject had severe hyperhomocysteinaemia.Homocysteine was higher (p=0.003) in subjects with Stage 2 systolic hypertension. Ln10Homocysteine was significantly (p<0.001) correlated with blood pressure (SBP: r=0.45; DBP: r=0.40) and age (r=0.33).
Conclusion: The prevalence of hyperhomocysteinaemia in North-Western Nigerian hypertensives is high as against normal healthy controls. Plasma homocysteine is higher with severe systolic hypertension and positively associated with age.
Keywords: Hypertension, Homocysteine, Blood pressure, Northern-Nigerians
Funding: No specific grants but Micro Nova Pharmaceuticals Limited, Nigeria and Emzor Pharmaceutical Industries, Lagos, Nigeria supported with drugs.
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Rosenbusch, R. F., L. C. Booth y L. A. Dahlgren. "Development of an in vitro Model for the Study of the Response of Equine Tendon Fibroblasts to Injury and Medication". Veterinary and Comparative Orthopaedics and Traumatology 10, n.º 01 (enero de 1997): 6–11. http://dx.doi.org/10.1055/s-0038-1632561.
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SummaryEquine tendon fibroblasts were isolated from explants of superficial digital flexor tendon, subcultured and maintained in monolayers. The cells were characterized by light microscopy, electron microscopy and radiolabel studies for proteoglycan production. Two predominant cell morphologies were identified. The cells dedifferentiated toward a more spindle shape with repeated subcultures. Equine tendon fibroblasts were successfully cryopreserved and subsequently subcultured. The ability to produce proteoglycan was preserved.The isolated cells were identified as fibroblasts, based on their characteristic shape by light microscopy and ultrastructure and the active production of extracellular matrix proteins. Abundant rough endoplasmic reticulum and the production of extracellular matrix products demonstrated active protein production and export. Proteoglycans were measurable via liquid scintillation counting in both the cell-associated fraction and free in the supernatant. This model is currently being utilized to study the effects of polysulfated glycosaminoglycan on tendon healing. Future uses include studying the effects of other pharmaceuticals, such as hyaluronic acid, on tendon healing.A model was developed for in vitro investigations into tendon healing. Fibroblasts were isolated from equine superficial digital flexor tendons and maintained in monolayer culture. The tenocytes were characterized via light and electron microscopy. Proteoglycan production was measured, using radio-label techniques. The fibroblasts were cryopreserved and subsequently subcultured. The cells maintained their capacity for proteoglycan production, following repeated subculturing and cryopreservation.
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Zadeshvariya, Prof Dr Ankita M. "Analysis of Debt – Equity Ratio of Selected Pharmaceutical Companies of India". International Journal of Trend in Scientific Research and Development Volume-2, Issue-2 (28 de febrero de 2018): 1216–20. http://dx.doi.org/10.31142/ijtsrd9683.
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Mutalik, Srinivas, UshaY Nayak, MSreenivasa Reddy, Pallavi Shetty, N. Udupa y Rohit Kalra. "Pharmaceutical applications of radio-frequency identification". Systematic Reviews in Pharmacy 3, n.º 1 (2012): 24. http://dx.doi.org/10.4103/0975-8453.107134.
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Schwarz, E. R., B. Bauer, D. Noßke, A. Erzberger, G. Brix y V. Minkov. "Application of radioactive substances in research in nuclear medicine: current trends and radiation exposure to the study subjects". Nuklearmedizin 40, n.º 04 (2001): 116–21. http://dx.doi.org/10.1055/s-0038-1625923.
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SummaryAim: Analysis of the application of radioactive substances in research in the field of nuclear medicine in human beings and of the resulting radiation exposure to study subjects. Methods: Assessment of applications for approval submitted in accordance with Paragraph 41 of the Radiation Protection Ordinance, evaluated by the Federal Office for Radiation Protection together with the Federal Institute for Pharmaceuticals and Medical Products, within the period from 1997 to 1999. Results: The focus of the studies on the diagnostic application of radioactive substances in medicine evaluated has, since 1998, shifted from oncological to neurological and psychological aspects, while, at the same time, the number of PET studies increased constantly. The proportion of healthy study subjects included in the diagnostic studies increased from 7 to 22%. The number of therapeutic applications of radioactive substances has, since 1997, undergone a three-fold increase, and in the process of this, the focus of attention lay within the area of radioimmuno-therapy and endovascular brachy-theropy. The effective dose was, among up to 49% of the investigated healthy study subjects higher than 5 mSv, and among up to 6% of these subjects was at levels of over 20 mSv. Up to 22% of the patients received, within the scope of diagnostic studies, an effective dose of between 20 and 50 mSv. An exceeding of the 50 mSv limit occurred among up to 3% of the patients. Conclusions: In spite of the increasing numbers of PET applications, conventional nuclear medicine has maintained its importance in the field of medical research. Further developments in the areas of radiochemistry and molecular biology led to an increase in the importance of radio-immuno therapy. The evaluation of new radiopharmaceuticals and the extension of basic biomedical research, resulted in an increase in the proportion of healthy study subjects included in the studies. The radiation exposure among subjects resulting directly from the studies showed, for the period of evaluation, an overall trend towards reduction.
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Tan, Haibo, Zhengwei Zhang, Weiqi Bao y Yihui Guan. "Preparation and preliminary biological evaluation of 11C-l-SPD". Traditional Medicine and Modern Medicine 01, n.º 02 (junio de 2018): 133–36. http://dx.doi.org/10.1142/s2575900018500064.
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Objective: To explore the method and quality control of [Formula: see text]C radiolabeled [Formula: see text]-SPD ([Formula: see text]-Stepholidine) and biodistribution of [Formula: see text]C-[Formula: see text]-SPD in vivo. Methods: (1) [Formula: see text]CO2 was produced by CTI RDS III cyclotron, converted [Formula: see text]CO2 to [Formula: see text]C–CH3I by CH3I die-block, and then converted it to [Formula: see text]C-Triflate–CH4, imported [Formula: see text]C-Triflate–CH4 to [Formula: see text]-SPD which was dissolved in Dimethyl sulfoxide [(CH3)2SO], reacted at common temperature and then obtained the product. (2) Take the sample of organs in different times 5, 15, 30, 60, 90[Formula: see text]min after injecting [Formula: see text]C-[Formula: see text]-SPD by vail in mice and measure the radioactive counts per minute (cpm), then the percent injection dose of wet tissue per gram (%ID/g) was calculated. Results: (1) The synthesis time of [Formula: see text]C-[Formula: see text]-SPD was 15 to 20[Formula: see text]min with chemical [Formula: see text]%, and PH values [Formula: see text], radiochemical [Formula: see text]% in 2[Formula: see text]h. All quality criteria of [Formula: see text]C-[Formula: see text]-SPD met the requirements of the positron radio-pharmaceuticals. (2) [Formula: see text]C-[Formula: see text]-SPD was of the characteristic that metabolism was through the liver, and kidney was the main excretory organ, which was [Formula: see text]%ID/g at 5[Formula: see text]min and was decreasing gradually, which was [Formula: see text][Formula: see text]ID/g in liver at 5[Formula: see text]min. Conclusion: (1) [Formula: see text]C-[Formula: see text]-SPD can be used to further study the animal or human. (2) [Formula: see text]C-[Formula: see text]-SPD could quickly discharge and decrease to the low level from background of issues in vivo.
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Kantilal, Dhulia Hirenkumar. "Financial Analysis of Selected Pharmaceutical Companies in India with Special Reference to Gross Profit to Sales Ratio". Indian Journal of Applied Research 2, n.º 2 (1 de octubre de 2011): 5–6. http://dx.doi.org/10.15373/2249555x/nov2012/2.
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Barkova, N. Yu, D. D. Zherega, E. A. Popova y V. P. Logacheva. "APPLICATION OF THE INTERNET OF THINGS IN PHARMACEUTICAL INDUSTRY SUPPLY CHAINS". Vestnik Universiteta, n.º 9 (26 de octubre de 2019): 68–74. http://dx.doi.org/10.26425/1816-4277-2019-9-68-74.
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Сurrent temperature monitoring, humidity, physical condition and real-time data transmission are extremely important in the pharmaceutical supply chains. The intelligent logistics system for monitoring the state of objects, implemented on the basis of the Internet of things, which can be used for the pharmaceutical industry, has been considered in this article. The two-level network architecture of the IOT platform has been reviewed. The first level is radio frequency object identification, and the second level is organization of wireless sensor network. By adapting the proposed system, the pharmaceutical company can easily monitor and control the quality of the goods during transportation.
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Distler, O., F. Kramer, J. Höfler, M. Ghadessi, P. Sandner, Y. Allanore, C. Denton et al. "FRI0575 BIOMARKER ANALYSIS FROM THE RISE-SSC STUDY OF RIOCIGUAT IN EARLY DIFFUSE CUTANEOUS SYSTEMIC SCLEROSIS (DCSSC)". Annals of the Rheumatic Diseases 79, Suppl 1 (junio de 2020): 890–91. http://dx.doi.org/10.1136/annrheumdis-2020-eular.3138.
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Background:RISE-SSc (NCT02283762) was a multicenter, double-blind, Phase IIb study of riociguat in early dcSSc. Primary endpoint was change in mRSS from baseline to Wk 52.Objectives:Exploratory, descriptive analyses of riociguat target engagement and effects on disease biomarkers in RISE-SSc and their relationship with effects on the primary endpoint. All biomarker p-values are for information only.Methods:Pts with dcSSc (duration ≤18 mo; modified Rodnan skin score [mRSS] 10–22 units) were randomized to riociguat 0.5−2.5 mg tid (n=60) or placebo (n=61). Biomarkers of target engagement (cGMP), inflammation and/or vascular/endothelial function (e.g. high-sensitivity C-reactive protein [hsCRP], soluble platelet endothelial cell adhesion molecule 1 [sPECAM-1], soluble E-selectin, chemokine ligand 4 [CXCL-4]), and fibrosis (e.g. alpha-smooth muscle cell actin [alphaSMA], pro-collagen mRNA expression) were measured in plasma, serum, and skin biopsies at baseline and Wk 14.Results:Mean±SD change from baseline in mRSS was –2.09±5.66 (n=57) with riociguat and –0.77±8.24 (n=52) with placebo (p=0.08). From baseline to Wk 14, plasma cGMP rose by mean (SD) 94% (78%) (n=52) with riociguat and 10% (39%) (n=52) with placebo (nominal p<0.001). Serum sPECAM-1 and CXCL-4 fell with riociguat vs placebo; changes in hsCRP or E-selectin differed little between groups (Fig 1). Pts with higher baseline sPECAM-1 showed larger mRSS reductions with riociguat vs placebo than pts with lower levels (nominal interaction p=0.004). In baseline skin biopsies, 34% and 31% of pts in the riociguat and placebo groups, respectively, had no alphaSMA-positive cells; other pts had +ve cells (alphaSMA counts 0.1–99.5, median 2.5), a potential indicator of higher disease activity. Pts with +ve baseline alphaSMA counts showed a reduction of mRSS with riociguat vs placebo (Fig 2). Skin collagen mRNA expression biomarkers in skin biopsies showed no differences between groups.Conclusion:Primary study endpoint (change in mRSS) was not met. Plasma cGMP rose with riociguat, confirming engagement with the NO-sGC-cGMP pathway. Serum sPECAM-1 (marker of endothelial activation) and CXCL-4 (marker of progressive SSc) fell with riociguat; hsCRP and E-selectin did not. Some serum and skin biomarkers of higher disease activity at baseline were associated with a greater effect of riociguat on skin fibrosis.Acknowledgments:RISE-SSc was jointly funded by Bayer AG and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.Disclosure of Interests:Oliver Distler Grant/research support from: Grants/Research support from Actelion, Bayer, Boehringer Ingelheim, Competitive Drug Development International Ltd. and Mitsubishi Tanabe; he also holds the issued Patent on mir-29 for the treatment of systemic sclerosis (US8247389, EP2331143)., Consultant of: Consultancy fees from Actelion, Acceleron Pharma, AnaMar, Bayer, Baecon Discovery, Blade Therapeutics, Boehringer, CSL Behring, Catenion, ChemomAb, Curzion Pharmaceuticals, Ergonex, Galapagos NV, GSK, Glenmark Pharmaceuticals, Inventiva, Italfarmaco, iQvia, medac, Medscape, Mitsubishi Tanabe Pharma, MSD, Roche, Sanofi and UCB, Speakers bureau: Speaker fees from Actelion, Bayer, Boehringer Ingelheim, Medscape, Pfizer and Roche, Frank Kramer Employee of: Bayer AG, Josef Höfler Employee of: Josef Höfler is an employee of Staburo GmbH, Munich, Germany, contracted by Bayer AG to perform the biomarker analyses, Mercedeh Ghadessi Employee of: Bayer AG, Peter Sandner Employee of: Bayer AG, Yannick Allanore Grant/research support from: BMS, Inventiva, Roche, Sanofi, Consultant of: Actelion, Bayer AG, BMS, BI, Christopher Denton Grant/research support from: GlaxoSmithKline, CSL Behring, and Inventiva, Consultant of: Medscape, Roche-Genentech, Actelion, GlaxoSmithKline, Sanofi Aventis, Inventiva, CSL Behring, Boehringer Ingelheim, Corbus Pharmaceuticals, Acceleron, Curzion and Bayer, Masataka Kuwana Grant/research support from: Acetelion, Consultant of: Acetelion, Bayer, Chugai, Corbus Pharmaceuticals, CSL Behring and Reata Pharmaceuticals. He was a member of the SENSCIS trial Steering Committee (Boehringer Ingelheim), Marco Matucci-Cerinic Grant/research support from: Actelion, MSD, Bristol-Myers Squibb, Speakers bureau: Acetelion, Lilly, Boehringer Ingelheim, Janet Pope Grant/research support from: AbbVie, Bristol-Myers Squibb, Eli Lilly & Company, Merck, Roche, Seattle Genetics, UCB, Consultant of: AbbVie, Actelion, Amgen, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Eicos Sciences, Eli Lilly & Company, Emerald, Gilead Sciences, Inc., Janssen, Merck, Novartis, Pfizer, Roche, Sandoz, Sanofi, UCB, Speakers bureau: UCB, Tatsuya Atsumi Grant/research support from: Eli Lily Japan K.K., Alexion Pharmaceuticals, Inc., Bristol-Myers Squibb Co., AbbVie Inc., Daiichi Sankyo Co., Ltd., Pfizer Inc., Chugai Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Co., Astellas Pharma Inc., Consultant of: Gilead Sciences, Inc., Eli Lilly Japan K.K., UCB Japan Co. Ltd., AbbVie Inc., Daiichi Sankyo Co., Ltd., Pfizer Inc., Chugai Pharmaceutical Co., Ltd., Speakers bureau: Eli Lilly Japan K.K., UCB Japan Co. Ltd., Bristol-Myers Squibb Co., AbbVie Inc., Eisai Co. Ltd., Otsuka Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Pfizer Inc., Chugai Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Co., Takeda Pharmaceutical Co., Ltd., Astellas Pharma Inc., Radim Bečvář Consultant of: Actelion, Roche, László Czirják Consultant of: Actelion, BI, Roche-Genentech, Lilly, Medac, Novartis, Pfizer, Bayer AG, Ellen De Langhe Consultant of: member of advisory board for Boehringer, Eric Hachlla: None declared, Tomonori Ishii: None declared, Osamu Ishikawa: None declared, Sindhu Johnson Grant/research support from: Boehringer Ingelheim, Corbus Pharmaceuticals, GlaxoSmithKline, Roche, Merck, Bayer, Consultant of: Boehringer Ingelheim, Ikaria, Kaisa Laapas Employee of: Partly in-sourced to Bayer, Valeria Riccieri: None declared, Elena Schiopu: None declared, Richard Silver: None declared, Vanessa Smith Grant/research support from: The affiliated company received grants from Research Foundation - Flanders (FWO), Belgian Fund for Scientific Research in Rheumatic diseases (FWRO), Boehringer Ingelheim Pharma GmbH & Co and Janssen-Cilag NV, Consultant of: Boehringer-Ingelheim Pharma GmbH & Co, Speakers bureau: Actelion Pharmaceuticals Ltd, Boehringer-Ingelheim Pharma GmbH & Co and UCB Biopharma Sprl, Chiara Stagnaro: None declared, Viginia Steen Grant/research support from: The associated affiliation has received grants/research from Boehringer Ingelheim, Corbus Pharmaceuticals, CSL Behring, Eicos, Galapagos, Immune Tolerance Network, Reata, Consultant of: Virginia Steen has acted as a consultant for Boehringer Ingelheim, Corbus, CSL Behring, Eicos, Forbius, Wendy Stevens: None declared, Gabriella Szücs: None declared, Marie-Elise Truchetet: None declared, Melanie Wosnitza Employee of: Bayer AG, Dinesh Khanna Shareholder of: Eicos Sciences, Inc./Civi Biopharma, Inc., Grant/research support from: Dr Khanna was supported by NIH/NIAMS K24AR063120, Consultant of: Acceleron, Actelion, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Corbus Pharmaceuticals, Horizon Therapeutic, Galapagos, Roche/Genentech, GlaxoSmithKline, Mitsubishi Tanabe, Sanofi-Aventis/Genzyme, UCB
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Tajima, May. "The Role of Technology Standardization in RFID Adoption". International Journal of IT Standards and Standardization Research 10, n.º 1 (enero de 2012): 48–67. http://dx.doi.org/10.4018/jitsr.2012010104.
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In the United States (U.S.) retail industry, endorsement from an industry key figure spurred the adoption of radio frequency identification (RFID), but this did not turn out to be the case within the pharmaceutical industry. In order to provide insight into adoption drivers that are specific to the pharmaceutical industry, this research develops a theoretical model of RFID adoption factors, in which: (i) technology standardization is the main driver; (ii) three aspects of RFID technology that need to be standardized are specified; (iii) special attention is given to the adoption behavior of late adopters, rather than the existing early adopters; and (iv) a specific context for the pharmaceutical industry is provided by taking into account the key industry characteristics. The model provides practical insight for dealing with some of the adoption challenges faced by the U.S. pharmaceutical industry.
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Singh, Inderbir, Manoj Kumar, Jaswinder Kaur y Hassan Y. Aboul-Enein. "Versatility of Radio Frequency Identification (RFID) Tags in the Pharmaceutical Industry". Instrumentation Science & Technology 36, n.º 6 (27 de octubre de 2008): 656–63. http://dx.doi.org/10.1080/10739140802451303.
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Khanna, D., J. Pope, M. Matucci-Cerinic, M. Kuwana, C. Denton, Y. Allanore, M. Wosnitza et al. "OP0249 LONG-TERM EXTENSION RESULTS OF RISE-SSC, A RANDOMIZED TRIAL OF RIOCIGUAT IN PATIENTS WITH EARLY DIFFUSE CUTANEOUS SYSTEMIC SCLEROSIS (DCSSC)". Annals of the Rheumatic Diseases 79, Suppl 1 (junio de 2020): 156.2–157. http://dx.doi.org/10.1136/annrheumdis-2020-eular.3671.
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Background:RISE-SSc (NCT02283762) was a multicenter Phase IIb trial of riociguat in pts with early (duration ≤18 months) dcSSc and modified Rodnan skin score (mRSS) 10−22 units. Pts were randomized double-blind to placebo or riociguat 0.5–2.5 mg t.i.d. for 52 weeks. The primary endpoint, mRSS change from baseline to Week (Wk) 52, did not reach statistical significance (p=0.08, riociguat vs placebo), but there were favorable trends in some other outcomes.Objectives:To present open-label long-term extension (LTE) results of RISE-SSc.Methods:Pts who completed Wk 52 of double-blind therapy could enter LTE on riociguat. Endpoints included mRSS, adverse events (AEs), and serious AEs (SAEs).Results:Of 60 pts randomized to riociguat and 61 to placebo, 42 (riociguat−riociguat group) and 45 (former placebo group), respectively, entered LTE. At LTE start, mean±SD mRSS was 16.4±3.2 and 16.3±4.2 units, and mean disease duration was 8.9±7.8 and 8.9±5.8 months, in the riociguat−riociguat and former placebo groups, respectively. Other demographics/disease characteristics were also comparable. Median duration of riociguat treatment was 1092 d in riociguat−riociguat pts and 649 d in former placebo pts. Throughout the study, mRSS decreased in both groups (Figure 1). From Wk 52 to last visit, mRSS fell by −3.02±5.51 in riociguat−riociguat patients and −3.96±5.43 in former placebo pts. Rates of mRSS regression (decrease by >5 units and ≥25% from Wk 52 to last visit) and of % declines in mRSS were similar in the two groups (Figure 2). mRSS progression (increase by >5 units and ≥25% from Wk 52 to last visit) occurred in 1 pt (2%) in each group. During the entire study, rescue therapy agents were used in 15 (36%) riociguat−riociguat pts and 17 (38%) former placebo pts. AEs were reported from Wk 52 to last visit in 82 pts (94%): 40 (95%) riociguat−riociguat and 42 (93%) former placebo. Most common AEs overall: nasopharyngitis (24%), gastroesophageal reflux disease (17%), diarrhea (15%), and hypotension (14%). AEs of special interest (dizziness, postural dizziness, or hypotension) occurred in 5 riociguat−riociguat pts (12%) and 4 former placebo pts (9%). SAEs were reported in 21 (24%) pts: 10 (24%) riociguat−riociguat pts and 11 (24%) former placebo pts, with no SAE reported in >1 patient, no SAEs of special interest, and no deaths.Conclusion:During LTE riociguat treatment, mRSS decreased in both groups from Wk 52 onwards and mRSS progression was uncommon. Riociguat had acceptable safety, similar to the main study, with no new safety signal.Acknowledgments:RISE-SSc was jointly funded by Bayer AG and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.Disclosure of Interests:Dinesh Khanna Shareholder of: Eicos, Grant/research support from: NIH NIAID, NIH NIAMS, Consultant of: Acceleron, Actelion, Bayer, BMS, Boehringer-Ingelheim, Corbus, Galapagos, Genentech/Roche, GSK, Mitsubishi Tanabi, Sanofi-Aventis/Genzyme, UCB Pharma, Janet Pope Grant/research support from: AbbVie, Bristol-Myers Squibb, Eli Lilly & Company, Merck, Roche, Seattle Genetics, UCB, Consultant of: AbbVie, Actelion, Amgen, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Eicos Sciences, Eli Lilly & Company, Emerald, Gilead Sciences, Inc., Janssen, Merck, Novartis, Pfizer, Roche, Sandoz, Sanofi, UCB, Speakers bureau: UCB, Marco Matucci-Cerinic Grant/research support from: Actelion, MSD, Bristol-Myers Squibb, Speakers bureau: Acetelion, Lilly, Boehringer Ingelheim, Masataka Kuwana Grant/research support from: Acetelion, Consultant of: Acetelion, Bayer, Chugai, Corbus Pharmaceuticals, CSL Behring and Reata Pharmaceuticals. He was a member of the SENSCIS trial Steering Committee (Boehringer Ingelheim), Christopher Denton Grant/research support from: GlaxoSmithKline, CSL Behring, and Inventiva, Consultant of: Medscape, Roche-Genentech, Actelion, GlaxoSmithKline, Sanofi Aventis, Inventiva, CSL Behring, Boehringer Ingelheim, Corbus Pharmaceuticals, Acceleron, Curzion and Bayer, Yannick Allanore Grant/research support from: BMS, Inventiva, Roche, Sanofi, Consultant of: Actelion, Bayer AG, BMS, BI, Melanie Wosnitza Employee of: Bayer AG, Marie-Elise Truchetet: None declared, Gabriella Szücs: None declared, Wendy Stevens: None declared, Viginia Steen Grant/research support from: The associated affiliation has received grants/research from Boehringer Ingelheim, Corbus Pharmaceuticals, CSL Behring, Eicos, Galapagos, Immune Tolerance Network, Reata, Consultant of: Virginia Steen has acted as a consultant for Boehringer Ingelheim, Corbus, CSL Behring, Eicos, Forbius, Chiara Stagnaro: None declared, Vanessa Smith Grant/research support from: The affiliated company received grants from Research Foundation - Flanders (FWO), Belgian Fund for Scientific Research in Rheumatic diseases (FWRO), Boehringer Ingelheim Pharma GmbH & Co and Janssen-Cilag NV, Consultant of: Boehringer-Ingelheim Pharma GmbH & Co, Speakers bureau: Actelion Pharmaceuticals Ltd, Boehringer-Ingelheim Pharma GmbH & Co and UCB Biopharma Sprl, Richard Silver: None declared, Elena Schiopu: None declared, Valeria Riccieri: None declared, Frank Kramer Employee of: Bayer AG, Sindhu Johnson Grant/research support from: Boehringer Ingelheim, Corbus Pharmaceuticals, GlaxoSmithKline, Roche, Merck, Bayer, Consultant of: Boehringer Ingelheim, Ikaria, Osamu Ishikawa: None declared, Tomonori Ishii: None declared, Eric Hachlla: None declared, Ellen De Langhe Consultant of: member of advisory board for Boehringer, László Czirják Consultant of: Actelion, BI, Roche-Genentech, Lilly, Medac, Novartis, Pfizer, Bayer AG, Radim Bečvář Consultant of: Actelion, Roche, Tatsuya Atsumi Grant/research support from: Eli Lily Japan K.K., Alexion Pharmaceuticals, Inc., Bristol-Myers Squibb Co., AbbVie Inc., Daiichi Sankyo Co., Ltd., Pfizer Inc., Chugai Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Co., Astellas Pharma Inc., Consultant of: Gilead Sciences, Inc., Eli Lilly Japan K.K., UCB Japan Co. Ltd., AbbVie Inc., Daiichi Sankyo Co., Ltd., Pfizer Inc., Chugai Pharmaceutical Co., Ltd., Speakers bureau: Eli Lilly Japan K.K., UCB Japan Co. Ltd., Bristol-Myers Squibb Co., AbbVie Inc., Eisai Co. Ltd., Otsuka Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Pfizer Inc., Chugai Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Co., Takeda Pharmaceutical Co., Ltd., Astellas Pharma Inc., Oliver Distler Grant/research support from: Grants/Research support from Actelion, Bayer, Boehringer Ingelheim, Competitive Drug Development International Ltd. and Mitsubishi Tanabe; he also holds the issued Patent on mir-29 for the treatment of systemic sclerosis (US8247389, EP2331143)., Consultant of: Consultancy fees from Actelion, Acceleron Pharma, AnaMar, Bayer, Baecon Discovery, Blade Therapeutics, Boehringer, CSL Behring, Catenion, ChemomAb, Curzion Pharmaceuticals, Ergonex, Galapagos NV, GSK, Glenmark Pharmaceuticals, Inventiva, Italfarmaco, iQvia, medac, Medscape, Mitsubishi Tanabe Pharma, MSD, Roche, Sanofi and UCB, Speakers bureau: Speaker fees from Actelion, Bayer, Boehringer Ingelheim, Medscape, Pfizer and Roche
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Donnard, J., N. Arlicot, R. Berny, H. Carduner, P. Leray, E. Morteau, N. Servagent y D. Thers. "Advancements of labelled radio-pharmaceutics imaging with the PIM-MPGD". Journal of Instrumentation 4, n.º 11 (25 de noviembre de 2009): P11022. http://dx.doi.org/10.1088/1748-0221/4/11/p11022.
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Van Vuren, Annelies J., Joannes J. M. Marx, Richard van Wijk y Eduard J. van Beers. "Striking Difference in Iron Utilization between Oral and Intravenous Iron in Various Anemias and Hemochromatosis". Blood 132, Supplement 1 (29 de noviembre de 2018): 2338. http://dx.doi.org/10.1182/blood-2018-99-113030.
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Abstract Introduction Patients with hereditary hemochromatosis (HH) and non-transfusion-dependent hereditary anemia (HA NTD) both express low hepcidin levels, leading to increased intestinal iron absorption and, ultimately, predominantly parenchymal iron overload. Knowledge about iron absorption in humans stems from iron absorption or utilization studies with radio-labeled iron performed in the 60-70s from the last century. Here, we present unique data of combined absorption and utilization studies in a large cohort of patients with primary and secondary hemochromatosis. Methods We retrospectively analyzed the data from iron absorption and kinetics studies performed from 1972 until 1994 as part of routine clinical practice in patients with iron-related health problems at the University Medical Center Utrecht, the Netherlands. A radioactive tracer dose of oral (1 mg) 59Fe with 51Cr as non-absorbable indicator, or intravenous (10 µCi) 59Fe was administered. Radio-activity was measured with a whole-body counter to assess absorption and with a gamma-counter to determine radio-activity in peripheral blood samples to calculate the amount of iron utilized for red blood cell (RBC) production. Main findings Iron absorption was analyzed in 6 distinct groups with and without iron overload and iron reducing therapy (table). Iron uptake is the percentage of the iron test dose taken up by enterocytes, retention the percentage retained in the body 14 days after ingestion, and transfer the fraction of iron taken up that is retained in the body. Iron uptake, transfer and retention were significantly higher in patients with treated and untreated HH and iron deficiency (ID) compared with healthy controls (p<0.01). Notably, uptake, transfer and retention were also significantly higher in the analyses of patients with treated or untreated HA NTD (including 19 congenital sideroblastic anemia, 6 hereditary spherocytosis, 5 congenital dyserythropoietic anemia, 3 non-transfusion dependent thalassemia, 4 Hb Adana, 2 hexokinase deficiency and 1 PKD) than in analyses of healthy controls (p<0.01). Next, iron retention was used to calculate the percentage of iron utilized for RBC production after 14 days. Mean percentages of RBC iron utilization (RBCIU) after an oral iron test dose were 37% (SD 17%) in untreated HA NTD, 53% (SD 19%) in treated HA NTD, 55% (SD 20%) in untreated HH, 70% (SD 22%) in treated HH, and 99% (SD 22%) in ID patients. Surprisingly, RBCIU was lower after oral than after intravenous iron in patients with HA NTD or HH (figure 1). The difference between oral and intravenous RBCIU was expressed as percentage of intravenous RBCIU, and denominated as the LIR (liver iron retention). The LIR had a mean value of 28% (SD 26%) in untreated HH, 23% (SD 24%) in untreated HA NTD, and 16% (SD 25%) in treated HH patients, all significantly higher than the LIR of 1% (SD 22%) measured in ID patients (p<0.05). The LIR was strongly correlated to iron saturation (r=0.41; p<0.01). Main conclusions Of major interest is the observation that a substantial fraction of oral iron retained in patients with iron overload was not utilized for erythropoiesis. Under circumstances of high transferrin saturation, a part of iron transported from enterocytes into the portal circulation will be non-transferrin-bound iron (NTBI). A part of this NTBI will be available as labile plasma iron (LPI), a form of iron with high redox potential, and the capacity to rapidly cross membranes via transporters and channels. Recently it was shown that in iron-overloaded conditions LPI is almost completely taken up after passage of the liver and this is facilitated by ZIP14 in a non-transferrin-dependent way. (Jenkitkasemwong et al. Cell Metabolism, 2015: 22(1), 138-150). We therefore hypothesize that LPI produced primarily in the portal system (oral dosed iron) is primarily taken up in the liver and that LPI produced elsewhere in the circulation (intravenous dosed iron) may be taken up by other organs as well. In conclusion, our data is suggestive of the existence of significant hepatic scavenging of NTBI/LPI under iron-overloaded conditions. This could explain the distinct patterns of transfusion-dependent and transfusion-independent iron overload and we suggest that ZIP14 could facilitate this. Disclosures van Wijk: Agios Pharmaceuticals: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; RR Mechatronics: Research Funding. van Beers:RR Mechatronics: Research Funding; Bayer: Research Funding; Agios: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Pfizer: Research Funding; Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding.
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Goldberg, Scott. "Advertising to the End Consumers by Pharmaceutical Companies". International Journal of Research in Business and Social Science (2147-4478) 2, n.º 4 (3 de octubre de 2013): 60–71. http://dx.doi.org/10.20525/ijrbs.v2i4.81.
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The last several years have seen an increase in the number of direct to consumer advertisements by pharmaceutical companies. Direct to Consumer advertisements (DTC) means targeting the end consumer through advertisements on television, radio, in newspapers, magazines, and the Internet. The qualitative study presents data and supports the need for a future quantitative study to ask physicians and consumers their opinions on whether pharmaceutical companies should be allowed to advertise directly to the end consumer. This article reviews the literature on this controversial topic, supporting the need to explore the reserach questions in greater detail. A review of the literature suggests there is financial motivation on the part of the pharmaceutical companies to increase their sales by advertsing directly to the end consumer as opposed to performing an educational service to the consumer.
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Gaudin, Alice, Sinda Lepetre-Mouelhi, Julie Mougin, Martine Parrod, Grégory Pieters, Sébastien Garcia-Argote, Olivier Loreau et al. "Pharmacokinetics, biodistribution and metabolism of squalenoyl adenosine nanoparticles in mice using dual radio-labeling and radio-HPLC analysis". Journal of Controlled Release 212 (agosto de 2015): 50–58. http://dx.doi.org/10.1016/j.jconrel.2015.06.016.
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Kuendgen, Andrea, Heinz Tuechler, Meritxell Nomdedeu, Detlef Haase, Guillermo Garcia-Manero, Rami S. Komrokji, Francesc Sole et al. "Frequency and Prognostic Significance of Cytogenetic Abnormalities in 1269 Patients with Therapy-Related Myelodysplastic Syndrome - a Study of the International Working Group (IWG-PM) for Myelodysplastic Syndromes (MDS)". Blood 128, n.º 22 (2 de diciembre de 2016): 112. http://dx.doi.org/10.1182/blood.v128.22.112.112.
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Abstract To develop a prognostic scoring system tailored for therapy-related myelodysplastic syndromes (tMDS), we put together a database containing 1933 patients (pts) with tMDS from Spanish, German, Swiss, Austrian, US, Italian, and Dutch centers diagnosed between 1975-2015. Complete data to calculate the IPSS and IPSS-R were available in 1603 pts. Examining different scoring systems, we found that IPSS and IPSS-R do not risk stratify tMDS as well as they do primary MDS (pMDS), thereby supporting the need for a tMDS-specific score (Kuendgen et al., ASH 2015). The current analysis focuses on cytogenetic information as a potential component of a refined tMDS score, based on this large, unique patient cohort. Of the 1933 pts, 477 had normal karyotype (KT), 197 had missing cytogenetics, while 467 had a karyotype not readily interpretable. Incomplete karyotype descriptions will be reedited for the final evaluation. Of the remaining 1269 pts the most frequent cytogenetic abnormalities (abn) were: -7, del(5q), +mar, +8, del(7q), -5, del(20q), -17, -18, -Y, del(12p), -20, and +1 with >30 cases each. Frequencies are shown in Table 1. Some abn were observed mostly or solely within complex KTs, such as monosomies, except -7. Others, like del(20q) or -Y, are mainly seen as single or double abn, while del(5q), -7, or del(7q) are seen in complex as well as non-complex KTs. The cytogenetic profile overlapped with that of pMDS (most frequent abn: del(5q), -7/del(7q), +8, -18/del(18q), del(20q), -5, -Y, -17/del(17p), +21, and inv(3)/t(3q) (Schanz et al, JCO 2011)), with notable differences including overrepresentation of complete monosomies, a higher frequency of -7 or t(11q23), and a more frequent occurrence of cytogenetic subtypes in complex KTs, which was especially evident in del(5q) occurring as a single abn in 16%, compared to 70% within a complex KT. IPSS-R cytogenetic groups were distributed as follows: Very Good (2%), Good (35%), Int (17%), Poor (15%), Very Poor (32%). Regarding the number of abn (including incomplete KT descriptions) roughly 30% had a normal KT, 20% 1, 10% 2, and 40% ≥3 abn, compared to pMDS: 55% normal KT, 29% 1, 10% 2, and 6% ≥3 abn. To be evaluable for prognostic information, abn should occur in a minimum of 10 pts. As a single aberration this was the case for -7, +8, del(5q), del(20q), del(7q), -Y, and t(11;varia) (q23;varia). Of particular interest, there was no apparent prognostic difference between -7 and del(7q); del(5q) as a single abn was associated with a relatively good survival, while the prognosis was poor with the first additional abn; t(11q23) occurred primarily as a single abn and was associated with an extremely poor prognosis, and prognosis of pts with ≥4 abn was dismal independent of composition (Table 1). To develop a more biologically meaningful scoring system containing homogeneous and prognostically stable groups, we will further combine subgroups with different abn leading to the same cytogenetic consequences. For example, deletions, unbalanced translocations, derivative chromosomes, dicentric chromosomes of 17p, and possibly -17 all lead to a loss of genetic material at the short arm of this respective chromosome affecting TP53. Further information might be derived from analyses of the minimal common deleted regions. For some abn, like del(11q), del(3p), and del(9q), this can be refined to one chromosome band only (table 1). Conclusion: Development of a robust scoring system for all subtypes of tMDS is challenging using existing variables. This focused analysis on the cytogenetic score component shows that favorable KTs are evident in a substantial proportion of pts, in contrast to historic data describing unfavorable cytogenetics in the majority of pts. Although complex and monosomal KTs are overrepresented, this suggests the existence of distinct tMDS-subtypes, although some of these cases might not be truly therapy-induced despite a history of cytotoxic treatment. The next steps will be to analyze the prognosis of the different groups, develop a tMDS cytogenetic score, and examine minimal deleted regions to identify candidate genes for development of tMDS, as well as to describe the possible influence of different primary diseases and treatments (radio- vs chemotherapy, different drugs) on induction of cytogenetic subtypes. Our detailed analysis of tMDS cytogenetics should reveal important prognostic information and is likely to help understand mechanisms of MDS development. Disclosures Komrokji: Novartis: Consultancy, Speakers Bureau; Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding. Sole:Celgene: Membership on an entity's Board of Directors or advisory committees. Sekeres:Celgene: Membership on an entity's Board of Directors or advisory committees; Millenium/Takeda: Membership on an entity's Board of Directors or advisory committees. Roboz:Cellectis: Research Funding; Agios, Amgen, Amphivena, Astex, AstraZeneca, Boehringer Ingelheim, Celator, Celgene, Genoptix, Janssen, Juno, MEI Pharma, MedImmune, Novartis, Onconova, Pfizer, Roche/Genentech, Sunesis, Teva: Consultancy. Steensma:Amgen: Consultancy; Genoptix: Consultancy; Janssen: Consultancy; Celgene: Consultancy; Millenium/Takeda: Consultancy; Ariad: Equity Ownership. Schlenk:Pfizer: Honoraria, Research Funding; Amgen: Research Funding. Valent:Amgen: Honoraria; Deciphera Pharmaceuticals: Research Funding; Celgene: Honoraria, Research Funding; Novartis: Honoraria, Research Funding; Ariad: Honoraria, Research Funding; Deciphera Pharmaceuticals: Research Funding. Giagounidis:Celgene Corporation: Consultancy. Giagounidis:Celgene Corporation: Consultancy. Platzbecker:Celgene Corporation: Honoraria, Research Funding; TEVA Pharmaceutical Industries: Honoraria, Research Funding; Novartis: Honoraria, Research Funding; Janssen-Cilag: Honoraria, Research Funding; Amgen: Honoraria, Research Funding. Lübbert:Janssen-Cilag: Other: Travel Funding, Research Funding; Celgene: Other: Travel Funding; Ratiopharm: Other: Study drug valproic acid.
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Gong, Amy, Ran Duan, Huai Wang, Xiang Kong, Tina Dong, Karl Tsim y Kelvin Chan. "Evaluation of the Pharmaceutical Properties and Value of Astragali Radix". Medicines 5, n.º 2 (21 de mayo de 2018): 46. http://dx.doi.org/10.3390/medicines5020046.
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KIMURA, Syojiro y Meiko TAIMATSU. "Study on Radio-decomposition of Pharmaceutical Component in Some Dosage and G-Values." RADIOISOTOPES 41, n.º 2 (1992): 71–78. http://dx.doi.org/10.3769/radioisotopes.41.2_71.
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Maneuski, D., F. Giacomelli, C. Lemaire, S. Pimlott, A. Plenevaux, J. Owens, V. O'Shea y A. Luxen. "On the use of positron counting for radio-Assay in nuclear pharmaceutical production". Applied Radiation and Isotopes 125 (julio de 2017): 9–14. http://dx.doi.org/10.1016/j.apradiso.2017.03.021.
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Celeste, Robert y Beth Ann Cusack. "EPCglobal Standards in the Pharmaceutical Industry: Toward a Safe and Secure Supply Chain". Journal of Pharmacy Practice 19, n.º 4 (agosto de 2006): 244–49. http://dx.doi.org/10.1177/0897190006293510.
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This article focuses on the value of standards and the industry's work to date on an ePedigree standard, track-and-trace and electronic product code (EPC)/radio frequency identification (RFID). Parallels are drawn between the development of the bar code standard in the 1970s by EPCglobal's parent company, GS1 US, and the activities seen today in the EPC/RFID marketplace. The article also touches on issues such as patient privacy, item identification, sensor technology. Last, the article identifies areas other than counterfeit that may benefit from the standards that are being developed today.
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Lobrano, Mary Beth, Joseph Higgins, Lowell Anthony, Eugene Woltering, Harold Neitzschman y Kevin McCarthy. "COMPUTED TOMOGRAPHY MANIFESTATIONS OF METASTATIC CARCINOID SYNDROME WITH RADIO-PHARMACEUTICAL RECEPTOR AND PATHOLOGIC CORRELATION". Southern Medical Journal 91, Supplement (octubre de 1998): S97. http://dx.doi.org/10.1097/00007611-199810001-00256.
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Dangayach, Poorva. "PHARMACEUTICAL SUPPLY CHAIN TRACKING SYSTEM BASED ON BLOCKCHAIN TECHNOLOGY AND RADIO FREQUENCY IDENTIFICATION TAGS". International Journal of Business Research 19, n.º 4 (1 de diciembre de 2019): 37–44. http://dx.doi.org/10.18374/ijbr-19-4.4.
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Ling, Louis. "While We Are Waiting: Imagining and Creating a Safe Drug Supply While We Await the Coming of the Radio Frequency Identification Track-and-Trace System". Journal of Pharmacy Practice 19, n.º 3 (junio de 2006): 153–60. http://dx.doi.org/10.1177/0897190006292946.
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This article will discuss the history of the present regulatory regime regarding pharmaceutical wholesaling and will demonstrate the deficiencies of the present system. Next, the article will show that the failings of the present regime are caused by a lack of regulatory diligence and fortitude and that one existing tool, namely, the paper pedigree, if properly used, could curb most of the deficiencies in the system. The article will conclude with concrete recommendations to regulators and the pharmaceutical industry that will make the drug supply safe again.