Academic literature on the topic 'Radiopharmaceuticals. Drugs Pharmacokinetics. Clinical trials'

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Journal articles on the topic "Radiopharmaceuticals. Drugs Pharmacokinetics. Clinical trials"

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Hörmann, Anton A., Maximilian Klingler, Christine Rangger, et al. "Radiopharmaceutical Formulation and Preclinical Testing of 68Ga-Labeled DOTA-MGS5 for the Regulatory Approval of a First Exploratory Clinical Trial." Pharmaceuticals 14, no. 6 (2021): 575. http://dx.doi.org/10.3390/ph14060575.

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The new minigastrin analog DOTA-MGS5 is a promising new candidate for targeting cholecystokinin-2 receptor (CCK2R)-expressing tumors. To enable the clinical translation of PET/CT imaging using 68Ga-labeled DOTA-MGS5, different quality and safety aspects need to be considered to comply with the regulatory framework for clinical trial application. The preparation of the radiopharmaceutical was established using a cassette-based automated synthesis unit. Product specifications, including analytical procedures and acceptance criteria, were adopted from Ph. Eur. monographs for other 68Ga-labeled ra
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Vidal, Aurelien, Cécile Bourdeau, Mathieu Frindel, et al. "ARRONAX Cyclotron: Setting up of In-House Hospital Radiopharmacy." BioMed Research International 2020 (March 10, 2020): 1–6. http://dx.doi.org/10.1155/2020/1572841.

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Whilst radiopharmaceuticals have an important role to play in both imaging and treatment of patients, most notably cancer patients, nuclear medicine and radiopharmacy are currently facing challenges to create innovative new drugs. Traditional radiopharmaceutical manufacture can be considered as either a routine hospital production or a large-scale industrial production. The gap between these two practices has meant that there is an inability to supply innovative radiopharmaceuticals for use at the local level for mono- or multicentric clinical trials with satisfactory quality and safety specif
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Garnett, William R. "Lamotrigine: Pharmacokinetics." Journal of Child Neurology 12, no. 1_suppl (1997): S10—S15. http://dx.doi.org/10.1177/0883073897012001041.

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The pharmacokinetics of lamotrigine have been studied in single and multiple dose studies in animals, normal volunteers, and patients with epilepsy. Lamotrigine exhibits first-order linear pharmacokinetics. Lamotrigine is well absorbed with bioavailability approaching 100%. The absorption is unaffected by food and there is no first-pass metabolism. The volume of distribution is between 1.25 and 1.47 L/kg and protein binding is about 55%. The half-life of lamotrigine is between 24.1 and 35 hours in drug naive adults but may be altered by enzyme inducing and inhibiting drugs. Clinical trials dem
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Fu, Jie, Fang Wang, Li-Hou Dong, et al. "Receptor occupancy measurement of anti-PD-1 antibody drugs in support of clinical trials." Bioanalysis 11, no. 14 (2019): 1347–58. http://dx.doi.org/10.4155/bio-2019-0090.

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Aim: The reliable measurement of receptor occupancy (RO) provides informative data for efficacy and safety evaluation. This study aimed to assess factors affecting RO measurement of anti-PD-1 antibodies in clinical studies. Materials & methods: RO performance was assessed using different T-cell activation markers measured by flow cytometry. The validated methodology was then used in support of a clinical study. Results: The optimized active cell population was comprised of CD45RO+ or CD45RA− T cells. The bioanalytical method was validated for inter- and intra-assay precision (coefficient o
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Jakovljevic, Mihajlo, Maj Jozef, Tomaz Vovk, Slobodan Jankovic, and Iztok Grabnar. "Current clinical evidence on topiramate pharmacokinetics." Srpski arhiv za celokupno lekarstvo 137, no. 7-8 (2009): 444–48. http://dx.doi.org/10.2298/sarh0908444j.

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Topiramate is biochemically classified as a fructopyranose sulphamate. Discovered as early as 1979, during middle 1980's it was approved in many countries for the treatment of epilepsies and migraine prevention. More recently, in the experimental stage, possible new indications have been disclosed: treatment of obesity, bipolar disorder, also cessation of smoking, neuropathic pain, cerebral pseudotumour, bulimia, periventricular leucomalatia in preterm infants and alcohol addiction. Most epileptologists consider it to be the first choice antiepileptic drug in severe pharmacoresistant epilepsie
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Harzallah, Ines, Josselin Rigaill, Nicolas Williet, Stephane Paul, and Xavier Roblin. "Golimumab pharmacokinetics in ulcerative colitis: a literature review." Therapeutic Advances in Gastroenterology 10, no. 1 (2016): 89–100. http://dx.doi.org/10.1177/1756283x16676194.

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Golimumab (GLM) is the latest anti-tumor necrosis factor (TNF) that gained its marketing license. Thanks to the PURSUIT induction and maintenance trials, it was approved for the treatment of ulcerative colitis (UC) in 2013. The other anti-TNF drugs available are infliximab and adalimumab. These two drugs have validated algorithms concerning prescription and therapeutic drug monitoring (TDM) but little is known about GLM. The available data on GLM’s exposure–response relationship in UC are from the PURSUIT trials and are recently published. The data reveal all the factors that may impact the ph
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KEISER, JENNIFER, KATRIN INGRAM, and JÜRG UTZINGER. "Antiparasitic drugs for paediatrics: systematic review, formulations, pharmacokinetics, safety, efficacy and implications for control." Parasitology 138, no. 12 (2011): 1620–32. http://dx.doi.org/10.1017/s0031182011000023.

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SUMMARYDrug development for paediatric applications entails a number of challenges, such as the wide age spectrum covered – from birth to adolescence – and developmental changes in physiology during biological maturation that influence the efficacy and toxicity of drugs. Safe and efficacious antiparasitic drugs for children are of pivotal importance given the large proportion of burden attributable to parasitic diseases in this age group, and growing efforts to administer, as widely as possible, antiparasitic drugs to at-risk populations, such as infants and school-aged children, often without
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Yatscoff, Randall W., Launa J. Aspeslet, and Heather L. Gallant. "Pharmacodynamic monitoring of immunosuppressive drugs." Clinical Chemistry 44, no. 2 (1998): 428–32. http://dx.doi.org/10.1093/clinchem/44.2.428.

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Abstract Pharmacodynamic (PD) monitoring measures the biological response to a drug, which alone—or coupled with pharmacokinetics— provides a novel method for optimization of drug dosing. PD monitoring has been investigated by us and other investigators primarily for four immunosuppressive drugs: cyclosporine (CsA), azathioprine (AZA), mycophenolate mofetil (MMF), and rapamycin (RAPA). PD monitoring of CsA and MMF involves measuring the activity of the enzymes calcineurin and inosine monophosphate dehydrogenase, respectively. The PD of AZA is assessed by measuring the activity of thiopurine me
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Pakes, Gary E. "Writing Clinical Investigator's Brochures on Drugs for a Pharmaceutical Company." Journal of Technical Writing and Communication 23, no. 2 (1993): 181–89. http://dx.doi.org/10.2190/63p5-wmtd-4644-60md.

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A clinical investigator's brochure is a summary of the preclinical and clinical information about a drug that is about to enter clinical trials. It serves to update clinical investigators on the possible benefits, risks, and areas of uncertainty still left to be studied. The writer of the clinical investigator's brochure can create a streamlined, succinct, and easily readable document by using a format that closely parallels the research and the development history of the drug, as follows: 1) Introduction, 2) Chemistry, 3) Pharmacy, 4) Animal Pharmacology, 5) Animal Toxicology, 6) Animal Pharm
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Gore, Lia, S. Percy Ivy, Frank M. Balis, et al. "Modernizing Clinical Trial Eligibility: Recommendations of the American Society of Clinical Oncology–Friends of Cancer Research Minimum Age Working Group." Journal of Clinical Oncology 35, no. 33 (2017): 3781–87. http://dx.doi.org/10.1200/jco.2017.74.4144.

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Purpose Children have historically been excluded from first-in-human studies of promising new cancer drugs and later phase adult clinical trials. Delays in evaluation may result in off-label use without dosing information as the only access to new drugs. A multistakeholder workshop was convened in May 2016 by ASCO and Friends of Cancer Research to identify opportunities for when it would be scientifically appropriate to expand trial eligibility to include children younger than age 18 years in first-in-human and other adult cancer clinical trials. Methods This group convened experts from academ
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Dissertations / Theses on the topic "Radiopharmaceuticals. Drugs Pharmacokinetics. Clinical trials"

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Onthank, David C. "Prediction of "First Dose in Human" for radiopharmaceuticals/imaging agents based on allometric scaling of pharmacokinetics in pre-clinical animal models." Link to electronic dissertation, 2005. http://www.wpi.edu/Pubs/ETD/Available/etd-011006-132234/.

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Onthank, David C. "Prediction of "First Dose in Human" for Radiopharmaceuticals/Imaging Agents Based on Allometric Scaling of Pharmacokinetics in Pre-Clinical Animal Models." Digital WPI, 2006. https://digitalcommons.wpi.edu/etd-dissertations/443.

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It is an FDA requirement that the“first in human" dose be based on pre-clinical animal model efficacy and safety testing to ensure a safe entry into Phase I clinical trials. Pre-clinical safety and efficacy models range from mouse to non-human primates. Interspecies scaling of pharmacokinetic parameters is therefore important for predicting drug doses in human clinical trials, although it continues to be less than optimal. Understanding the disposition of the compound in different species through in vitro and in vivo experiments is necessary to ensure appropriate species are selected for human
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Reis, Margareta. "Pharmacokinetics of antidepressant drugs : naturalistic and clinical trials /." Linköping : Univ, 2003. http://www.bibl.liu.se/liupubl/disp/disp2003/med783s.pdf.

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Mao, Xuezhou. "Sequential Designs for Individualized Dosing in Phase I Cancer Clinical Trials." Thesis, 2014. https://doi.org/10.7916/D857196S.

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This dissertation presents novel sequential dose-finding designs that adjust for inter-individual pharmacokinetic variability in phase I cancer clinical trials. Unlike most traditional dose-finding designs whose primary goals are the determination of a maximum safe dose, the goal of our proposed designs is to estimate a patient-specific dosing function such that the responses of patients can achieve a target safety level. Extending from a single compartment model in the pharmacokinetic theory, we first postulate a linear model to describe the relationship between the area under concentra
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Li, Claire. "Modeling and simulation applications with potential impact in drug development and patient care." Thesis, 2014. http://hdl.handle.net/1805/5969.

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Indiana University-Purdue University Indianapolis (IUPUI)<br>Model-based drug development has become an essential element to potentially make drug development more productive by assessing the data using mathematical and statistical approaches to construct and utilize models to increase the understanding of the drug and disease. The modeling and simulation approach not only quantifies the exposure-response relationship, and the level of variability, but also identifies the potential contributors to the variability. I hypothesized that the modeling and simulation approach can: 1) leverage our un
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Books on the topic "Radiopharmaceuticals. Drugs Pharmacokinetics. Clinical trials"

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Simulation for Designing Clinical Trials: A Pharmacokinetic-Pharmacodynamic Modeling Perspective (Drugs and the Pharmaceutical Sciences, Vol 127) (Drugs and the Pharmaceutical Sciences). Informa Healthcare, 2002.

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1964-, Kimko Hui C., and Duffull Stephen B. 1964-, eds. Simulation for designing clinical trials: A pharmacokinetic-pharmacodynamic modeling perspective. Marcel Dekker, 2003.

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(Editor), M. Schwaiger, L. Dinkelborg (Editor), and H. Schweinfurth (Editor), eds. From Morphological Imaging to Molecular Targeting: Implications to Preclinical Development (Ernst Schering Research Foundation Workshop). Springer, 2004.

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Book chapters on the topic "Radiopharmaceuticals. Drugs Pharmacokinetics. Clinical trials"

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Busutti, L., A. Petralia, A. Breccia, and E. Ferri. "Bioreductive Drugs and Radiation: Pharmacokinetics and Clinical Trials of Etanidazole Radiosensitizer." In Selective Activation of Drugs by Redox Processes. Springer US, 1990. http://dx.doi.org/10.1007/978-1-4615-3768-7_27.

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Rolan, Paul, and Valeria Molnar. "The Assessment of Pharmacokinetics in Early-Phase Drug Evaluation." In Clinical Trials of Drugs and Biopharmaceuticals. CRC Press, 2005. http://dx.doi.org/10.1201/9781420039146.pt3.

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"The Assessment of Pharmacokinetics in Early-Phase Drug Evaluation." In Clinical Trials of Drugs and Biopharmaceuticals. CRC Press, 2005. http://dx.doi.org/10.1201/9781420039146-19.

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Pathak, Atul. "Autonomic nervous system drugs." In ESC CardioMed. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780198784906.003.0033.

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Drugs able to modulate the autonomic nervous system have improved the outcome of many cardiovascular and non-cardiovascular conditions. In particular, heart failure, post-myocardial infarction, and hypertension are the cardiovascular clinical syndromes in which autonomic nervous system inhibition or stimulation has modified patient outcomes. While in heart failure and post-myocardial infarctions beta blockers have become a cornerstone therapy by improvement of morbidity and mortality, their use in hypertension has been progressively limited. The same is true for other drugs modulating the autonomic nervous system such as alpha blockers, used only in patients with difficult to control hypertension and not in heart failure patients, in whom this class of drugs exacerbates heart failure in clinical trials. This chapter aims to provide an appraisal of drugs modulating the autonomic nervous system with descriptions of their mechanism(s) of action, pharmacokinetics, adverse effects, and drug interactions.
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Barron, Carol, and Eleanor Hollywood. "Drug administration." In Clinical Skills in Children's Nursing. Oxford University Press, 2010. http://dx.doi.org/10.1093/oso/9780199559039.003.0015.

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By the end of this chapter you will be introduced to the concepts of pharmacokinetics and pharmacodynamics with specific emphasis on the infant, child, and young person. You will be presented with the current evidenced- based practice in relation to differing routes of drug administration in children and young people, underpinned by a firm rationale throughout. The key points to consider when administering medications via differing routes to children will be explored. Throughout this chapter the importance and method of drug calculations and mental mathematics will be highlighted, as befits their importance in the safe preparation and administration of all medications. It is anticipated that you will be able to do the following once you have read and studied this chapter: ● Discuss pharmacokinetics and pharmacodynamics as they relate to drug administration with children. ● Understand the mathematical calculations required to accurately prepare and administer medications in children. ● Understand the key nursing skills required to administer medications to children and young people via differing routes. Historically, drug development specifically for children was only conducted for common disorders/diseases where medication was part of the accepted treatment. Examples are medicines for epilepsy or asthma, antibiotics, or vaccines (Rose, 2005). Because the numbers of children are small in comparison with adults, and the child population is subdivided into age groups from neonates to teenagers, pharmaceutical companies are governed by the commercial market. Consequently they assign limited resources to drug development in the child population because of more limited profit margins. However, this situation is changing, as the European Union established a European Network for Drug Investigation in Children in 1998, with a commitment to improve both clinical use and research into drugs for children (Van den Anker &amp; Choonara, 1999). An international meta-register of controlled clinical trials has been created where particular emphasis is placed on paediatric aspects (Bonati et al., 2001). All of these initiatives serve to change the prevailing view of children as ‘therapeutic orphans’ to an acknowledgement that children are consumers of healthcare services and as such have the right both ethically and morally to medications that are designed and trialled for them specifically.
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Reports on the topic "Radiopharmaceuticals. Drugs Pharmacokinetics. Clinical trials"

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Johnson, Corey, Colton James, Sarah Traughber, and Charles Walker. Postoperative Nausea and Vomiting Implications in Neostigmine versus Sugammadex. University of Tennessee Health Science Center, 2021. http://dx.doi.org/10.21007/con.dnp.2021.0005.

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Purpose/Background: Postoperative nausea and vomiting (PONV) is a frequent complaint in the postoperative period, which can delay discharge, result in readmission, and increase cost for patients and facilities. Inducing paralysis is common in anesthesia, as is utilizing the drugs neostigmine and sugammadex as reversal agents for non-depolarizing neuromuscular blockers. Many studies are available that compare these two drugs to determine if neostigmine increases the risk of PONV over sugammadex. Sugammadex has a more favorable pharmacologic profile and may improve patient outcomes by reducing P
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