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Therapeutic Innovation & Regulatory Science|September 22, 2018
Detecting Data Quality Issues in Clinical Trials: Current Practices and RecommendationsDavid Knepper, Christian Fenske, Patrick Nadolny, et al.
Therapeutic Innovation & Regulatory Science|September 22, 2018
Defining Regions in Multiregional Clinical Trials: An Analytical Approach to Considering Impact of Intrinsic and Extrinsic FactorsYoko Tanaka, Andrew Buchanan, Sarah Lipsius, et al.
Therapeutic Innovation & Regulatory Science|May 11, 2018
Drug Information Association Pharmacovigilance and Risk Management Strategies 2017: Overview of the Generic Drug Program and SurveillanceHoward D Chazin, John R Peters, Debra M Catterson, et al.
Therapeutic Innovation & Regulatory Science|July 5, 2018
Validation Master Plans: Progress of Implementation in the Pharmaceutical IndustryClare Elser, Frances J Richmond
Therapeutic Innovation & Regulatory Science|May 26, 2018
Developing, Planning and Conducting an Interim Analysis: Lessons From the DEVOTE Cardiovascular Outcomes Trial (Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Patients With Type 2 Diabetes at High Risk of Cardiovascular Events)Hanne Theilgaard, Inger Mollerup, Ida Carøe Helmark, et al.
Therapeutic Innovation & Regulatory Science|October 26, 2021
Heart Failure Population with Therapeutic Response to Sacubitril/Valsartan, Spironolactone and Candesartan: FDA PerspectiveCharu Gandotra, Jennifer Clark, Ququan Liu, et al.
Therapeutic Innovation & Regulatory Science|April 26, 2022
Global Regulatory and Public Health Initiatives to Advance Pediatric Drug Development for Rare DiseasesCarla Epps, Ralph Bax, Alysha Croker, et al.
Therapeutic Innovation & Regulatory Science|June 18, 2019
A Systematic Approach for Post Hoc Subgroup Analyses With Applications in Clinical Case StudiesChristoph Muysers, Alex Dmitrienko, Hermann Kulmann, et al.
Therapeutic Innovation & Regulatory Science|October 11, 2019
Principles and Considerations for Responsible Sharing of Safety Information Via the Medical Information ChannelSashka Hristoskova, James Milligan, Jan De Wit, et al.
Therapeutic Innovation & Regulatory Science|February 16, 2022
Attitudes of Chinese Patients with Non-alcoholic Fatty Liver Disease Toward Participation in Clinical Trials from a National Multicenter SurveyRui Huang, Huiying Rao, Fangfang Lv, et al.
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