Case Study Bioanalytical Approaches To Mitigate Issues During A Be Inspection Bioanalysis 2020

Summary

Arindam Dasgupta, Deputy Director, Division of New Drug Zhen Zhang, CDER Office of Generic Drugs, explains how to identify Drs. Seongeun Julia Cho and John Kadavil from CDER's Division of Generic Drug Bioequivalence Evaluation and Office of Director of the Office of Translational Sciences (OTS) ShaAvhrée Buckman-Garner, MD, PhD, FAAP, opened the meeting ... Ruben Ayala, CDER Office Translational Sciences, discusses Presenters Patrick Faustino, Jinhui Zhang, and Diaa Shakleya respond to audience questions. FDA CDER's Small Business and ... Melkamu Getie-Kebtie, CDER Office of Diaa Shakleya, CDER Office of Pharmaceutical Quality (OPQ), discusses Tian Ma, CDER Office of Generic Drugs, summarize common reasons/codes of Presenters Melkamu Getie-Kebtie, Xiaohan Cai, Cynthia Zhang, Ruben Ayala, and Gabriel Davila respond to audience questions. Drs. Charles Bonapace and Arindam Dasgupta from CDER's Division of New Drug Bioequivalence Evaluation and Office of The process of tackling biosimilar projects