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Therapeutic Innovation & Regulatory Science|June 20, 2020
Quantifying Patient Subpopulation Disparities in New Drugs and Biologics Approved Between 2007 and 2017Kenneth A Getz, Zachary P Smith, Yaritza PeñaTherapeutic Innovation & Regulatory Science|June 20, 2020
Adverse Drug Reaction Relief System in Japan: From Clinical PerspectiveMeguru Watanabe, Hiroki Nishikawa, Nobuyuki Miyasaka, et al.Therapeutic Innovation & Regulatory Science|June 20, 2020
Understanding the Essentialities in Establishing the Bioequivalence of Oral Inhalation Drug Products to be Marketed in the USASwapnil Dylan Fernandes, Marina KolandTherapeutic Innovation & Regulatory Science|June 20, 2020
Considerations and Regulatory Challenges for Innovative Medicines in Expedited Approval Programs: Breakthrough Therapy and Sakigake DesignationEiji Kajiwara, Mayumi ShikanoTherapeutic Innovation & Regulatory Science|June 20, 2020
Leveraging Research Failures to Accelerate Drug Discovery and DevelopmentHelen YuTherapeutic Innovation & Regulatory Science|June 20, 2020
Reducing Patient Burden in Clinical Trials Through the Use of Historical Controls: Appropriate Selection of Historical Data to Minimize Risk of BiasJessica Lim, Li Wang, Nicky Best, et al.Therapeutic Innovation & Regulatory Science|June 20, 2020
Evaluation of the Performance of the South Africa Regulatory Agency: Recommendations for Improved Patients' Access to MedicinesAndrea Keyter, Sam Salek, Joey Gouws, et al.Therapeutic Innovation & Regulatory Science|June 20, 2020
Analysis of FDA Warning Letters Issued to Indian Pharmaceutical and Medical Device Companies: A Retrospective StudyShray Bablani, Manthan D JanodiaTherapeutic Innovation & Regulatory Science|August 20, 2022
The Midazolam RAMPART Study Medical Records Project: A Unique Use of Real-World Data in a Complex Collaborative Partnership to Support a New Drug ApplicationNancy A Sherman, Robert Silbergleit, Erin M Bengelink, et al.Therapeutic Innovation & Regulatory Science|September 3, 2022
Innovations in Pediatric Therapeutics Development: Principles for the Use of Bridging Biomarkers in Pediatric ExtrapolationThomas R Fleming, Christine E Garnett, Laurie S Conklin, et al.Pageof 165