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Therapeutic Innovation & Regulatory Science|February 5, 2021
A Decade of Marketing Authorization Applications of Anticancer Drugs in the European Union: An Analysis of Procedural TimelinesMarjolein Garsen, Maaike Steenhof, Alex ZwiersTherapeutic Innovation & Regulatory Science|February 5, 2021
Hypothalamic-Pituitary-Adrenal Axis Pediatric Safety Studies Submitted to the FDAJanelle M Burnham, Dionna J Green, Amber Ray, et al.Therapeutic Innovation & Regulatory Science|February 22, 2019
Process Management Framework: Guidance to Successful Implementation of Processes in Clinical DevelopmentMichael Edward Husovich, Ruzica Zadro, Lora Lee Zoller-Neuner, et al.Therapeutic Innovation & Regulatory Science|August 21, 2019
Patient Feedback on a Warfarin Action Plan Used in a Local Australian Physician Practice SettingAngela W P Yiu, Vincent W Lee, Kingsley K Ng, et al.Therapeutic Innovation & Regulatory Science|July 30, 2019
Global Pediatric Regulations: An OverviewPriya M Gadge, Prathmesh P Kenjale, Varsha B Pokharkar, et al.Therapeutic Innovation & Regulatory Science|November 2, 2018
Public Understanding and Awareness of Isotretinoin Use and Safety in Al Ahsa, Eastern Saudi ArabiaNancy S Younis, Nourah Yousef Al-HarbiTherapeutic Innovation & Regulatory Science|October 24, 2018
The Potential Role of Individual-Level Benefit-Risk Assessment in Treatment Decision Making: A DIA Study Endpoints Community WorkstreamMatthew Reaney, Elizabeth Bush, Mary New, et al.Therapeutic Innovation & Regulatory Science|August 2, 2019
A Comparison Between a Meta-analytic Approach and Power Prior Approach to Using Historical Control Information in Clinical Trials With Binary EndpointsNaoki Isogawa, Kentaro Takeda, Kazushi Maruo, et al.Therapeutic Innovation & Regulatory Science|September 28, 2019
Postmarketing Safety of Biosimilars: Current Status, Challenges, and Opportunities in the Spontaneous Reporting SystemAbhishek Singh, Muthusamy Kalaivani, Sushma Srivastava, et al.Therapeutic Innovation & Regulatory Science|September 28, 2019
Single-Study Approvals: Quantum of Evidence RequiredFrank J Sasinowski, Michelle L ButlerPageof 165