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Artykuły w czasopismach na temat „Approval stage”

Autor: Grafiati

Data publikacji: 3 czerwca 2025

Data aktualizacji: 31 lipca 2025

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1

Kochan, Iryna. "Ukrainian Terminology: Approval Stage." Terminological Bulletin, no. 5 (2019): 25–32. http://dx.doi.org/10.37919/2221-8807-2019-5-3.

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The article deals with today’s achievements of Ukrainian terminology, covering the description of multi-sector terminology systems in dissertations, monographs, dictionaries, the article also traces various stages of the origin and formation of individual terminological systems, their current state, which gave grounds to set up the stage of national terminology establishment and its further development. During the Independence period, more than 200 dissertations were defended, which concerned the formation and development of Ukrainian branch terminology systems, which covered the most diverse

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Oliveira, Bruna Andrade dos Santos, Lucas de Oliveira Bernardes, Adriano Menis Ferreira, et al. "Impact of Educational Intervention on Cleaning and Disinfection of an Emergency Unit." International Journal of Environmental Research and Public Health 17, no. 9 (2020): 3313. http://dx.doi.org/10.3390/ijerph17093313.

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We aimed to evaluate the impact of an educational intervention on the surface cleaning and disinfection of an emergency room. This is an interventional, prospective, longitudinal, analytical and comparative study. Data collection consisted of three stages (Stage 1—baseline, Stage 2—intervention and immediate assessment, Stage 3—long term assessment). For the statistical analysis, we used a significance level of α = 0.05. The Wilcoxon and the Mann–Whitney test tests were applied. We performed 192 assessments in each stage totaling 576 evaluations. Considering the ATP method, the percentage of a

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Reddy, D. Samba. "An Overview of Novel Drugs and New Chemical Entities in 2013." International Journal of Pharmaceutical Sciences and Nanotechnology 7, no. 3 (2014): 2505–8. http://dx.doi.org/10.37285/ijpsn.2014.7.3.1.

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Twenty-seven (27) new drugs have been approved by the U.S. FDA in 2013, a big decline compared to 39 in 2012. The decline is attributed to fewer drugs submitted for review. The average annual approval rate over the past eight years is 26 new molecular entities (NMEs) comprising small molecules and biologics. The approval of 27 novel new drugs is a strong sign of innovation in drug discovery and commercialization. This list includes 9 first-in-class drugs, 9 orphan drugs, 10 fast track drugs, 10 priority drugs, 3 breakthroughs, 2 accelerated aprovals and 12 combined expedited approval products.

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&NA;. "Mitoxantrone nearing approval for late-stage prostate cancer." Inpharma Weekly &NA;, no. 1055 (1996): 22. http://dx.doi.org/10.2165/00128413-199610550-00046.

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Frantz, John A. "Two-stage drug approval would reduce the risks." Nature 435, no. 7039 (2005): 143. http://dx.doi.org/10.1038/435143b.

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Caggiano, Vincent, and Carol Parise. "Who gets treated at commission on cancer-approved programs and does it make a difference in survival?" Journal of Clinical Oncology 31, no. 26_suppl (2013): 114. http://dx.doi.org/10.1200/jco.2013.31.26_suppl.114.

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114 Background: Commission on Cancer (CoC) approval has promoted improvements in cancer care in the United States. The purpose of this study is to determine if there are differences in who is treated at CoC approved versus non-approved sites and if CoC approval is associated with survival. Methods: We examined 130,655 cases of stages I-IV first primary female invasive breast cancer from the California Cancer Registry diagnosed between 2000-2010. Odds ratios (95% CI) adjusted for stage, age, grade, year of diagnosis, and ER/PR/HER2 were computed to determine if there were differences by race: w

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Dawood, S. S., C. Albaracin, A. Gonzalez-Angulo, M. Markman, and B. Hennessy. "Effect of introduction of paclitaxel on survival among women with stage III and IV ovarian cancer." Journal of Clinical Oncology 27, no. 15_suppl (2009): 5536. http://dx.doi.org/10.1200/jco.2009.27.15_suppl.5536.

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5536 Background: The objective of this study was to evaluate survival over time in relation to FDA approval of paclitaxel (P) for second- and first-line treatment in a population-based cohort of women with stage III and de novo stage IV ovarian cancer. Methods: The Surveillance, Epidemiology, and End Results (SEER) program was searched to identify 8,267 and 10,746 women with stage III and stage IV epithelial ovarian cancer diagnosed between 1988–2004. Women were divided according to their year of diagnosis and year of FDA approval of P for second- (1992) and first-line(1998) treatment of ovari

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DiMasi, Joseph A., and Henry G. Grabowski. "Economics of New Oncology Drug Development." Journal of Clinical Oncology 25, no. 2 (2007): 209–16. http://dx.doi.org/10.1200/jco.2006.09.0803.

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Purpose Review existing studies and provide new results on the development, regulatory, and market aspects of new oncology drug development. Methods We utilized data from the US Food and Drug Administration (FDA), company surveys, and publicly available commercial business intelligence databases on new oncology drugs approved in the United States and on investigational oncology drugs to estimate average development and regulatory approval times, clinical approval success rates, first-in-class status, and global market diffusion. Results We found that approved new oncology drugs to have a dispr

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&NA;. "FDA Approval for Zykadia for Late-Stage Lung Cancer." Oncology Times 36, no. 10 (2014): 8. http://dx.doi.org/10.1097/01.cot.0000450371.08810.54.

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Harris, Tina. "Gaining approval for clinical research in third stage management." British Journal of Midwifery 6, no. 8 (1998): 532–34. http://dx.doi.org/10.12968/bjom.1998.6.8.532.

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Sofaer, Neema, and Nir Eyal. "Translational Research Beyond Approval: A Two-Stage Ethics Review." American Journal of Bioethics 10, no. 8 (2010): W1—W3. http://dx.doi.org/10.1080/15265161.2010.500199.

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Ahmed, Sagheer. "Lessons from the Aducanumab Approval Saga." Molecular Medicine Communications 2, no. 01 (2022): 01. http://dx.doi.org/10.55627/mmc.002.001.0077.

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One year ago, the US Food and Drug Administration (FDA) approved a drug that aims to degrade β-amyloid, a molecular target for the treatment of Alzheimer’s disease (AD). The drug, aducanumab-a monoclonal antibody, was the first drug to be approved by the FDA in the last 20 years for treating AD. The approval of this drug through an ‘accelerated approval process’ came as a shock to the scientific community working in the field of neuroscience. It was not the ‘accelerated approval process’ itself that shocked the most, the process is in place since 1992, primarily to expedite the approval

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13

Kipli, Kumalasari, Fara Diva Mustapa, Shariffah Zatil Hidayah Syed Jamaluddin, and Favilla Zaini. "KNOWLEDGE MANAGEMENT PROCESS IMPLEMENTATION IN PRIVATE FINANCE INITIATIVE PROJECT IN MALAYSIA." Journal of Information System and Technology Management 6, no. 24 (2021): 109–17. http://dx.doi.org/10.35631/jistm.624011.

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PFI involved a project with long-term relationships at various stages from pre-contract stage to contractual stage and in use stage which also include maintenance stage. KM process is one of the elements to ensure the success of the KM system. In the PFI project, the KM process also needs to be checked whether it is applied in the various stage of the pre-contract stages. Questionnaires had been distributed to the parties involved at the pre-contract stage. The results are then analyse using the Relative Important Index (RII) to identify the ranking of KM usage in various stages of the pre-con

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Maria, Sylvia Macchione Saes. "Editorial Facing the challenge of the desk review approval." RAUSP Management Journal 53, no. 2 (2018): 139–40. https://doi.org/10.5281/zenodo.2602129.

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Recently, RAUSP Management Journal has received many queries from potential collaborators about the determining factors for an article to be accepted for the blind-review evaluation process. These may have arisen because there is now a greater rigor in the evaluation during the desk review phase, what has led to the increased rejection of articles at the very beginning of the process. These concerns derive from one of our journal’s new policies: the desk review process now comprises three stages. The first is to check if the submission was made correctly: to verify if the authors have se

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D., Sarika Prathyusha* Brahmaiah Bonthagarala M.V. Ngabhushanam and D. Nagarjuna Reddy. "MARKETING AUTHORIZATION PROCESS OF NEW DRUG SUBSTANCES IN U.S.A AND EUROPE." Indo American Journal of Pharmaceutical Sciences 04, no. 06 (2017): 1690–98. https://doi.org/10.5281/zenodo.821854.

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A regulatory process, by which a person/organization/sponsor/innovator gets authorization to launch a drug in the market, is known as drug approval process. In general, a drug approval process comprises of various stages: application to conduct clinical trials, conducting clinical trials, application to marketing authorization of drug and post-marketing studies. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. This work focuses on the drug approval process in India. Develop

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Coerver, Katherine, Melissa M. Yu, Anelyssa D'Abreu, Marc Wasserman, and Kavita V. Nair. "Practical Considerations in the Administration of Aducanumab for the Neurologist." Neurology: Clinical Practice 12, no. 2 (2021): 169–75. http://dx.doi.org/10.1212/cpj.0000000000001144.

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Aducanumab (Aduhelm), developed by the biotechnology firm Biogen in Cambridge, MA, was approved using the less common accelerated approval pathway by the Federal Drug Administration (FDA) reserved for treatments that fill a significant unmet need.1 Its approval on June 7, 2021, has been met with an outpouring of opinions from prescribers, insurers, advocacy groups, and hospital systems regarding its risk-benefit profile.2-4 Originally approved for all forms of Alzheimer disease (AD), the FDA updated aducanumab's labeling on July 8, 2021, for “treatment in patients with mild cognitive impairmen

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&NA;. "FDA Approval for Cetuximab for Late-Stage Head & Neck Cancer." Oncology Times 33, no. 23 (2011): 24. http://dx.doi.org/10.1097/01.cot.0000410211.22294.ce.

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Vytovtov, Aleksey, Andrey Kalach, and Pavel Ageev. "FIRE PROTECTION SYSTEMS EXAMINATION AT THE SPECIAL TECHNICAL CONDITIONS APPROVAL STAGE." Problems of risk management in the technosphere 2024, no. 4 (2024): 51–61. https://doi.org/10.61260/1998-8990-2025-2024-4-51-61.

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Modeling emergency situations during the design phase of a protected object should occur in the absence of established design standards and the formulation of specific technical conditions. The generation of these solutions necessitates a comprehensive analysis of the protected object and a high level of expertise in fire safety matters. It is recommended that territorial regulatory and technical councils collaborate with specialists from specialized educational and research institutions affiliated with EMERCOM of Russia when evaluating special technical conditions. This collaboration may invo

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Iurash, I. "Peace agreements at certain stages of the civil process." Uzhhorod National University Herald. Series: Law 1, no. 78 (2023): 251–56. http://dx.doi.org/10.24144/2307-3322.2023.78.1.40.

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The article is devoted to the analysis of the main theoretical and practical problems of the classification of settlement agreements according to the criterion of the stages of the civil process. The author supports the concept common in the theory of the civil process, according to which the stages of the civil process are distinguished according to the criterion of the closest procedural goal. According to this approach, it is claimed that it is possible to single out settlement agreements that can be concluded at the stage of preparatory proceedings, the stage of dispute settlement with the

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Lamba, Nayan, Timothy Smith, and Bryan Iorgulescu. "IMMU-02. THE SURVIVAL OUTCOMES ASSOCIATED WITH IMMUNE CHECKPOINT INHIBITORS FOR NON-SMALL CELL LUNG CARCINOMA PATIENTS WITH BRAIN METASTASES IN THE UNITED STATES." Neuro-Oncology 22, Supplement_2 (2020): ii104—ii105. http://dx.doi.org/10.1093/neuonc/noaa215.433.

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Abstract BACKGROUND Management of advanced NSCLC has been transformed by PD-1/PD-L1 immune checkpoint inhibitors (ICI), with FDA approvals in 2015 (second-line) and 2016 (first-line). Because patients with brain metastases (BMs) were disproportionately excluded from the pioneering trials, herein we evaluated the overall survival (OS) associated with ICI in NSCLC BMs nationally. METHODS Patients newly-diagnosed with stage 4 NSCLC, including BMs, from 2010–2016 were identified from the National Cancer Database (comprising &gt;70% of all newly-diagnosed cancers in the U.S.) Post-approval, med

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Mendenhall, William M., Stephanie Smith, Christopher G. Morris, et al. "Insurance Coverage for Adjuvant Proton Therapy in the Definitive Treatment of Breast Cancer." International Journal of Particle Therapy 6, no. 2 (2019): 26–30. http://dx.doi.org/10.14338/ijpt-19-00070.1.

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Abstract Purpose: To determine factors that influence insurance approval for breast cancer patients for whom adjuvant proton therapy (PT) is recommended. Patients and Methods: We sought to identify factors associated with PT approval among 131 insured patients seen in consultation between 2014 and 2018 and recommended adjuvant PT. Insurance status included: commercial, 76 patients (58%); Medicare, 41 (31%); and Medicaid, 14 (11%). Ninety-six patients (73%) had policies that “covered” PT. Insurance “coverage” for PT was not associated with final approval nor was lack of “coverage” associated wi

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Zou, Denise, Eileen Zhang, Sherry Wu, and Virgil Rose. "Use of Single-Arm Trials in FDA Approvals of Treatments in Relapsed or Refractory B-Cell Lymphoma." Blood 142, Supplement 1 (2023): 7250. http://dx.doi.org/10.1182/blood-2023-189855.

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Background: Single-arm trials are commonly used to evaluate therapies targeting life-threatening or rare diseases (e.g., late-stage cancers that are relapsed or refractory to prior interventions). A number of oncology products supported by single-arm trials have been approved by the United States Food and Drug Administration (FDA). The draft guidance issued by the FDA on 24 March 2023 recommended key considerations for trial design and analysis when a single-arm trial is considered appropriate to support accelerated approval. The objective of this study was to assess how often anticancer drugs

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White, Richard L., Sally Jeanne Trufan, Nicole Lee Gower, Brittany Neelands, and Asim Amin. "Disparities in use of immunotherapy for stage III and IV melanoma patients." Journal of Clinical Oncology 38, no. 15_suppl (2020): e19087-e19087. http://dx.doi.org/10.1200/jco.2020.38.15_suppl.e19087.

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e19087 Background: Approval of immune checkpoint inhibitors (ICIs), ipilimumab (ipi), nivolumab and pembrolizumab has significantly changed the outcome for patients with stage III and IV melanoma. Adoption of ICI based immunotherapy (IT) and utilization has not been studied. We sought to assess the utilization of ICI therapy and identify barriers that limit access. Methods: The National Cancer Database (2004-2016) was used to analyze stage III and IV melanoma patients separately using descriptive statistics, univariable and multivariable models to compare use of IT (yes/no) with sex, race, age

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Bekimbetova, G. "ANALYSIS AND EVALUATION OF THE EFFICIENCY OF INVESTMENT PROJECTS IN THE REPUBLIC OF UZBEKISTAN." Slovak international scientific journal, no. 63 (May 10, 2022): 30–34. https://doi.org/10.5281/zenodo.6535033.

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An analysis of the development of investment projects in Uzbekistan was carried out. A general description of the international practice of existing methods for evaluating the effectiveness of investment projects/programs is presented. The substantiation of the expediency of making investment decisions in relation to the selected projects/programs is presented. The presented stages are the development and implementation of an investment project / program, namely: organizational and preparatory stage; stage of direct development of the project/program; stage of coordination and approval of the

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Kuzmin, Stanislav E. "Mergers and Acquisitions of Joint Stock Companies in Russia and Corporations in the US (legal regulation experience)." Moscow Journal of International Law 96, no. 4 (2014): 163–74. http://dx.doi.org/10.24833/0869-0049-2014-4-163-174.

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The procedure of merger and consolidation of joint stock companies in Russia is legislatively ﬁ xed in the Federal law «On joint stock companies». In the United States in each state the rules on mergers are adopted within the Corporation laws. The greatest interest represents the law of the state of Delaware. This procedure includes three steps. In Russia at the ﬁ rst stage the companies sign an agreement on merger or consolidation, and in the state of Delaware, the ﬁ rst step is the adoption by the Board of Directors of each participating corporation of a decision on approval of the agreement

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Fedoreshchenko, Nikolay, and Mihail Levitin. "PRELIMINARY ANALYSIS OF THE MODERNIZATION OF METAL-CUTTING MACHINES." Bulletin of the Angarsk State Technical University 1, no. 15 (2022): 78–81. http://dx.doi.org/10.36629/2686-777x-2021-1-15-78-81.

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The method of modernization and analysis of the choice of the electric motor are shown. It has been established that it is expedient to carry out modernization based on a feasibility study in several stages with the development and approval of technical documentation at each stage

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Rafi, Achmad, Muharman Lubis, R. Wahjoe Witjaksono, and Nguyen Kieu Trang. "Development Of Means Of Engagement (Moe) Concepts For The Use Of Enterprise Resource Planning (Erp) At The Approval Level." Electronic Integrated Computer Algorithm Journal 1, no. 1 (2023): 32–40. http://dx.doi.org/10.62123/enigma.v1i1.4.

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The cause of ERP system implementation failure in companies can be caused by several factors, so we need a model that can be applied, especially at the stage of approval for system use. This study aims to analyze what factors influence approval for product use (approval) in implementing an ERP system in a company and to analyze what factors have a positive and significant influence on the success or failure of system implementation in terms of approval. Research systematics through several stages, namely the stages of review, collection, analysis, and interpretation. The object of this researc

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Curtin, Nicola J. "The Development of Rucaparib/Rubraca®: A Story of the Synergy Between Science and Serendipity." Cancers 12, no. 3 (2020): 564. http://dx.doi.org/10.3390/cancers12030564.

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The poly(ADP-ribose) polymerase (PARP) inhibitor, Rubraca®, was given its first accelerated approval for BRCA-mutated ovarian cancer by the FDA at the end of 2016, and further approval by the FDA, EMA and NICE followed. Scientists at Newcastle University initiated the early stages, and several collaborations with scientists in academia and the pharmaceutical industry enabled its final development to the approval stage. Although originally considered as a chemo- or radiosensitiser, its current application is as a single agent exploiting tumour-specific defects in DNA repair. As well as involvin

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Elen, Elen. "Mombolasuako Perspektif Istihsan Studi di Kecamatan Loea Kabupaten Kolaka Timur." KALOSARA: Family Law Review 4, no. 2 (2024): 101. https://doi.org/10.31332/kalosara.v4i2.5225.

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Girls are required to introduce and ask their parents' permission before choosing a life partner, but if they do not get permission from their family, then the child will elope. This research is a field study that uses descriptive qualitatif and the data collestion technige uses theree methods namely Observation, interviews and documentation. Based on the research findings, there are several variables that cause couples to elope (mombolasuko) in Loea District, East Kolaka Regency, including: (1) the girl's parents do not approve; and (2) a large dowry. The situation of couples who elope is sti

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Mulesa, Oksana, Yurii Bilak, Yevhenii Kykyna, and Dmytro Ferens. "Development of decision approval rules in multichannel decision-making systems." Technology audit and production reserves 6, no. 2(62) (2021): 6–9. http://dx.doi.org/10.15587/2706-5448.2021.244665.

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The research is devoted to the development of rules for the coordination of decisions in multichannel decision-making systems. Systems are considered that in an automated continuous mode process incoming signals from different channels and, on their basis, make the final decision. One of the most problematic stages in the operation of such systems is their own coordination of solutions received from different channels. There may be cases where different channels provide signals with opposite values. Then the choice of the decisive solution should depend on the reliability of the channels under

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Jung, Sun-Kyu, Won-Chang Kim, Gyu-Yong Kim, and Tae-Gyu Lee. "Improving Building Permit System via Case Analysis of Temporary Buildings in Industrial Facilities." Fire Science and Engineering 38, no. 3 (2024): 18–24. http://dx.doi.org/10.7731/kifse.c0d94c1a.

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In this study, a permit approval-stage review is proposed for the building permit system based on a case analysis of temporary buildings in domestic industrial facilities, with the aim of preventing the construction and use of connected temporary buildings following permit approval. To this end, design characteristics of connected temporary buildings are analyzed, and problems caused by the construction of such architectures are compiled based on actual incidents involving the breakout of fire. Based on our observations, we propose a minimum separation distance of 5 m as fire suppression space

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Raitt, Petrina, and Stacey Fidgeon. "Competency framework: environmental approval specialists." APPEA Journal 59, no. 2 (2019): 698. http://dx.doi.org/10.1071/aj18172.

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Environmental approvals take time, and scheduling and planning for their preparation and submission should be high on the list of priorities when planning a project. Understanding the regulatory process and knowing what level of information is required at each stage is critical. Providing quality environmental support to the oil and gas industry requires not only an understanding of the range of petroleum activities and their potential impacts and risks, but extensive knowledge of environmental receptors in each operational area, an understanding of complex technical methods for impact and ris

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Lamba, Nayan, and Bryan Iorgulescu. "196 Checkpoint blockade therapy for brain-metastatic non-small cell lung cancer: a comparative effectiveness analysis of national data." Journal for ImmunoTherapy of Cancer 8, Suppl 3 (2020): A211. http://dx.doi.org/10.1136/jitc-2020-sitc2020.0196.

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BackgroundManagement of advanced non-small cell lung carcinoma (NSCLC) has been transformed by PD-1/PD-L1 immune checkpoint inhibitors (ICI), with FDA approvals in 2015 (second-line) and 2016 (first-line). Despite ~40% of NSCLC patients developing brain metastases, these patients were disproportionately excluded from the pioneering ICI trials. Thus herein we evaluate the overall survival (OS) associated with ICI in NSCLC brain metastases nationally.MethodsPatients newly-diagnosed with stage 4 NSCLC, including brain metastases, from 2010–2016 were identified from the National Cancer Database (c

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Ghisa, Claudia, and Kenneth R. Zaslav. "Novel Treatment Options for Knee Cartilage Defects in 2023." Sports Medicine and Arthroscopy Review 32, no. 2 (2024): 113–18. http://dx.doi.org/10.1097/jsa.0000000000000398.

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Articular cartilage lesions are a common injury that have become increasingly treatable with joint preservation procedures. Well-documented allograft and cellular treatments for these lesions are detailed elsewhere in this volume. This article discusses three new unique options for addressing these defects taking three different paths to address these complex injuries. Agili-C is an existing FDA- and EMEA-approved option using an acellular aragonite-based scaffold to treat both chondral and osteochondral lesions, with or without concurrent arthritis. Cartistem is a stem-cell-based product comp

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Gromova, Mariya, Annegret Vaggelas, Gabriele Dallmann, and Diane Seimetz. "Biomarkers: Opportunities and Challenges for Drug Development in the Current Regulatory Landscape." Biomarker Insights 15 (January 2020): 117727192097465. http://dx.doi.org/10.1177/1177271920974652.

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Biomarkers are widely used at every stage of drug discovery and development. Utilisation of biomarkers has a potential to make drug discovery, development and approval processes more efficient. An overview of the current global regulatory landscape is presented in this article with particular emphasis on the validation and qualification of biomarkers, as well as legal framework for companion diagnostics. Furthermore, this article shows how the number of approved drugs with at least 1 biomarker used during development (biomarker acceptance) is affected by the recent advances in the biomarker re

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Oksana, Mulesa, Bilak Yurii, Kykyna Yevhenii, and Ferens Dmytro. "Development of decision approval rules in multichannel decision-making systems." Technology Audit and Production Reserves 6, no. 2(62) (2021): 6–9. https://doi.org/10.15587/2706-5448.2021.244665.

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<em>The research is devoted to the development of rules for the coordination of decisions in multichannel decision-making systems. Systems are considered that in an automated continuous mode process incoming signals from different channels and, on their basis, make the final decision. One of the most problematic stages in the operation of such systems is their own coordination of solutions received from different channels. There may be cases where different channels provide signals with opposite values. Then the choice of the decisive solution should depend on the reliability of the channels u

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Powell, Kerrington, and V. Prasad. "Concerning FDA approval of trilaciclib (Cosela) in extensive-stage small-cell lung cancer." Translational Oncology 14, no. 11 (2021): 101206. http://dx.doi.org/10.1016/j.tranon.2021.101206.

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Danese, Silvio, Elmer Schabel, Mark Andrew Ainsworth, and Laurent Peyrin-Biroulet. "Challenges and opportunities for IBD drug development: from early stage to regulatory approval." Gut 69, no. 7 (2020): 1157–61. http://dx.doi.org/10.1136/gutjnl-2019-320542.

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Oliveira, Ana Paula Cavalcante de, Ana Beatriz Zanardo Mion, Helen Fernanda Barbosa Batista, et al. "Prioritization criteria in policies and management of human resources for health: a proposal for a validated methodology." Revista Panamericana de Salud Pública 48 (May 2, 2024): 1. http://dx.doi.org/10.26633/rpsp.2024.39.

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Objective. To create and validate criteria for prioritizing problems related to policies and management of the health workforce. Methods. This methodological study was divided into three stages. First, the criteria were elaborated by means of a systematized literature review. Second, the criteria were evaluated online by a committee of judges comprised of eight specialists. In the third stage, an evaluation was carried out by the target audience in a hybrid workshop. The participants evaluated the material using the Suitability Assessment of Materials instrument, adapted for the research. Resu

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Sofia, Natalia, Stefan Mühlebach, Umberto M. Musazzi, et al. "How Do Hospital Pharmacists Approach Substitution of Nanomedicines? Insights from a Qualitative Pilot Study and a Quantitative Market Research Analysis in Five European Countries." Pharmaceutics 13, no. 7 (2021): 1010. http://dx.doi.org/10.3390/pharmaceutics13071010.

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We conducted research to assess hospital pharmacists’ familiarity with/interpretation of data requirements for the different regulatory approval frameworks and the impact of this on their approach to substitution in the formulary. The online questionnaire included a small molecule (acetylsalicylic acid—follow-ons approved via the generic pathway), two biologic drugs (insulin glargine and etanercept—follow-ons approved via the biosimilar pathway), a non-biologic complex drug (NBCD; glatiramer acetate—follow-ons approved via the hybrid pathway) and a nanomedicine, ferric carboxymaltose (no follo

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Murphy, David S., and Scott Yetmar. "Petty Corruption in a Multi-Person, Multi-Stage Bureaucratic Process: Formal Models and an Experimental Assessment." Research in Economics and Management 4, no. 1 (2019): 69. http://dx.doi.org/10.22158/rem.v4n1p69.

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<p><em>This paper examines the case where a citizen faces a sequence of bureaucrats in a transaction approval process. Each bureaucrat has the authority to disapprove an application and all of the bureaucrats must approve an application for it to be accepted. Each bureaucrat also has the ability to request a facilitating payment during the review process. Models are developed to explain bureaucrat behavior when there are no sanctions present to moderate the requests for facilitating payments, and where another government official with the authority to impose penalties on corrupt be

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VOLKOV, ARTEM. "WAYS OF PROTECTING THE RIGHTS OF PERSONS INVOLVED IN CRIMINAL PROCEEDINGS AT THE STAGE OF APPROVAL BY THE PROSECUTOR OF THE ACT ENDING THE PRELIMINARY INVESTIGATION WITH SENDING THE CASE TO COURT." LEGAL BULLETIN 4, no. 8 (2023): 114–22. https://doi.org/10.5281/zenodo.11190399.

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Despite the presence of a fairly developed system of ways to protect human rights and freedoms, in criminal proceedings there is a high risk of their violation. The protection of human rights and freedoms at a special stage of pre-trial proceedings - when the prosecutor approves the act ending the preliminary investigation with the referral of the case to the court - has not been sufficiently developed both at the legislative and doctrinal levels, which makes it urgent to search for ways to optimally construct methods for constructing such protection. The main goal of the work is to analyze th

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Santini, Ario, and Kenneth A. Eaton. "An Introduction to Research for Primary Dental Care Clinicians." Primary Dental Care os18, no. 3 (2011): 127–32. http://dx.doi.org/10.1177/2050168411os1800312.

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This paper, the fourth in the series, will address the sixth of the ten stages of a research project suggested in the first paper. The ten suggested stages are: 1. The initial idea (asking a research question). 2. Searching the literature. 3. Refining the research question. 4. Planning the study. 5. Writing a protocol. 6. Obtaining ethical approval and funding. 7. Piloting the methodology and project management. 8. Collecting data. 9. Analysing the data. 10. Writing up and disseminating the results. A previous paper1 has outlined the how to plan a research project. The next stage has two eleme

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Santini, Ario, and Kenneth A. Eaton. "An Introduction to Research for Primary Dental Care Clinicians." Primary Dental Care os18, no. 3 (2011): 133–35. http://dx.doi.org/10.1177/2050168411os1800315.

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This paper, the fifth in the series, will address the sixth of the ten stages of a research project suggested in the first paper. The ten suggested stages are: 1. The initial idea (asking a research question). 2. Searching the literature. 3. Refining the research question. 4. Planning the study. 5. Writing a protocol. 6. Obtaining ethical approval and funding. 7. Piloting the methodology and project management. 8. Collecting data. 9. Analysing the data. 10. Writing up and disseminating the results. A previous paper1 has outlined the how to plan a research project. The next stage has two elemen

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Volkmer, Anna, David A. Copland, Maya L. Henry, et al. "COS-PPA: protocol to develop a core outcome set for primary progressive aphasia." BMJ Open 14, no. 5 (2024): e078714. http://dx.doi.org/10.1136/bmjopen-2023-078714.

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IntroductionThe term primary progressive aphasia (PPA) describes a group of language-led dementias. Disease-modifying treatments that delay, slow or reverse progression of PPA are currently lacking, though a number of interventions to manage the symptoms of PPA have been developed in recent years. Unfortunately, studies exploring the effectiveness of these interventions have used a variety of different outcome measures, limiting comparability. There are more constructs, apart from word retrieval, that are important for people with PPA that have not received much attention in the research liter

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Hladkykh, Dmytro M., Victoria Oleshko, and Nataliya Berladir. "Role of pembrolizumab in relapsed Hodgkin lymphoma patients." American Journal of BioMedicine 11, no. 4 (2023): 172–85. http://dx.doi.org/10.18081/2333-5106/2023.11/172.

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About 10–15% of patients with early-stage and 15-30% with relapsed Hodgkin lymphoma after primary conventional treatment. Despite the approval of novel therapies, autologous stem cell transplantation (ASCT) remains the standard of care in these patients. However, up to half of transplanted individuals may relapse. Pembrolizumab is an FDA-approved monoclonal antibody directed against programmed cell death protein 1 (PD-1), it has received approval for the treatment of solid cancer and showed increased progression-free survival in high-risk patients with relapsed Hodgkin lymphoma receiving autol

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Stoen, Ericson, Jodi Kagihara, Elena Shagisultanova, et al. "Real-world evidence from a University Hospital system regarding the uptake of adjuvant pertuzumab and/or neratinib before and after their FDA approval." Breast Cancer Research and Treatment 187, no. 3 (2021): 883–91. http://dx.doi.org/10.1007/s10549-021-06132-8.

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Abstract Purpose Adjuvant pertuzumab and neratinib are independently FDA-approved for treatment of early-stage HER2-positive breast cancer in combination with or following trastuzumab for one year, respectively. Both agents reduce the risk of recurrence; however, the absolute benefit is modest for many patients with added risk of adverse effects. The purpose of this study was to evaluate the clinical use of adjuvant pertuzumab and neratinib in patients with early-stage HER2-positive breast cancer. Methods Patients diagnosed with stage I–III HER2-positive breast cancer treated with trastuzumab

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Zhao, Jingxuan, Ilana Graetz, David Howard, Robin Yabroff, and Joseph Lipscomb. "Association of immune checkpoint inhibitor introduction and changes in survival disparities by health insurance coverage among individuals newly diagnosed with advanced cancers in the US." Journal of Clinical Oncology 42, no. 16_suppl (2024): 1580. http://dx.doi.org/10.1200/jco.2024.42.16_suppl.1580.

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1580 Background: First approved by the US Food and Drug Administration (FDA) in 2011, immune checkpoint inhibitors (ICIs) have transformed treatment options for many cancers. Unfortunately, due to their high cost, individuals without health insurance coverage may not be able to afford them. Therefore, the introduction of ICIs may lead to greater disparities in cancer survival between patients with and without health insurance. This study examined the association of health insurance with changes in survival disparities associated with the introduction of ICIs. Methods: We identified individuals

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Almusalami, Eman M., Mohammed I. Al-Bazroun, Amal I. Alhasawi, et al. "Acceptance, Advocacy, and Perception of Health Care Providers on COVID-19 Vaccine: Comparing Early Stage of COVID-19 Vaccination with Latter Stage in the Eastern Region of Saudi Arabia." Vaccines 11, no. 2 (2023): 488. http://dx.doi.org/10.3390/vaccines11020488.

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Vaccination of healthcare providers has recently gained focused attention of public health officials. As HCPs have direct contact with the population, and HCPs significantly influence the population, this study aimed to compare the acceptance rate, advocacy rate, and beliefs about the COVID-19 vaccine among HCPs in two time periods. In this repeated cross-sectional study, different HCPs were assessed in two periods ten months apart, i.e., November to December 2020 and September to October 2021, which were before and after COVID-19 vaccine approval by authorities. The study was conducted in Qat

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Lee, Kyungsik, Hana Yoo, Sumin Shin, et al. "A Submodular Optimization Approach to Accountable Loan Approval." Proceedings of the AAAI Conference on Artificial Intelligence 38, no. 21 (2024): 22761–69. http://dx.doi.org/10.1609/aaai.v38i21.30310.

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In the field of finance, the underwriting process is an essential step in evaluating every loan application. During this stage, the borrowers' creditworthiness and ability to repay the loan are assessed to ultimately decide whether to approve the loan application. One of the core components of underwriting is credit scoring, in which the probability of default is estimated. As such, there has been significant progress in enhancing the predictive accuracy of credit scoring models through the use of machine learning, but there still exists a need to ultimately construct an approval rule that tak

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