The South African Medicines Control Council: Comparison of Its Registration Process With Australia, Canada, Singapore, and Switzerland [PDF]
, 2019 © 2019 Keyter, Salek, Banoo and Walker.Introduction: Comparisons between regulatory authorities of similar size and regulatory characteristics facilitate value-added benchmarking and provide insight into regulatory performance. Such comparisons highlight
Banoo, Shabir +3 more
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Verification, Analytical Validation, and Clinical Validation (V3): The Foundation of Determining Fit-for-Purpose for Biometric Monitoring Technologies (BioMeTs) [PDF]
, 2020 Digital medicine is an interdisciplinary field, drawing together stakeholders with expertize in engineering, manufacturing, clinical science, data science, biostatistics, regulatory science, ethics, patient advocacy, and healthcare policy, to name a few.
Bakker, Jessie +14 more
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The End Game of Deregulation: Myopic Risk Management and the Next Catastrophe [PDF]
, 2012 By using the Kingston Fossil Fuel Plant’s spill into the Emory River as a case study, this article offers several explanations for why the twentieth century dynamic of crisis and reform has disappeared in the early twenty-first century.
McGarity, Thomas O., Steinzor, Rena I.
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Frontiers in Pharmacology, 2022 Objective: The study aimed to assess the cost-effectiveness of sintilimab combined with cisplatin plus paclitaxel versus chemotherapy alone as first-line treatment in patients with advanced or metastatic esophageal squamous cell carcinoma from the ...
Jian Shen +7 more
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Defining Tobacco Regulatory Science Competencies [PDF]
Nicotine & Tobacco Research, 2016 In 2013, the National Institutes of Health and the Food and Drug Administration funded a network of 14 Tobacco Centers of Regulatory Science (TCORS) with a mission that included research and training. A cross-TCORS Panel was established to define tobacco regulatory science (TRS) competencies to help harmonize and guide their emerging educational ...
Heather L, Wipfli +8 more
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The regulation of diffuse pollution in the European Union:science, governance and water resource management [PDF]
, 2012 Reducing diffuse pollution is a perpetuating problem for environmental regulators. This paper will consider novel ways to regulate its impacts on the aquatic environment, with particular reference to rural landuse.
Hendry, Sarah, Reeves, Alison
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DanQ: a hybrid convolutional and recurrent deep neural network for quantifying the function of DNA sequences. [PDF]
, 2016 Modeling the properties and functions of DNA sequences is an important, but challenging task in the broad field of genomics. This task is particularly difficult for non-coding DNA, the vast majority of which is still poorly understood in terms of ...
Quang, Daniel, Xie, Xiaohui
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Predicting potential adverse events using safety data from marketed drugs
BMC Bioinformatics, 2020 Background While clinical trials are considered the gold standard for detecting adverse events, often these trials are not sufficiently powered to detect difficult to observe adverse events.
Chathuri Daluwatte +4 more
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Pharmacy Education, 2020 Accepted abstracts under the theme: REGULATORY SCIENCES (n=10)
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Science-based safety assessment of genetically modified DP915635 maize
GM Crops & FoodGenetically modified maize event DP-915635-4 expressing the IPD079Ea protein was developed to control corn rootworm damage to maize plants. Utilizing a modernized safety assessment model published by CropLife International (CLI), the safety of DP-915635 ...
Kent Brink +7 more
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