Panel Discussion Bioanalysis 2020

Summary

Presenters Patrick Faustino, Jinhui Zhang, and Diaa Shakleya respond to audience questions. FDA CDER's Small Business and ... Zhen Zhang and Tian Ma from the CDER Office of Generic Drugs respond to audience questions. FDA CDER's Small Business ... Presenters Sriram Subramaniam and Salaheldin S. Hamed respond to answer audience questions. FDA CDER's Small Business ... Zhen Zhang, CDER Office of Generic Drugs, explains how to identify challenges in establishing bioequivalence (BE) of drug ... Presenters Melkamu Getie-Kebtie, Xiaohan Cai, Cynthia Zhang, Ruben Ayala, and Gabriel Davila respond to audience questions. Salaheldin S. Hamed, CDER Office of Clinical Pharmacology, provides an introduction to biosimilars to include submission ... Director of the Office of Translational Sciences (OTS) ShaAvhrée Buckman-Garner, MD, PhD, FAAP, opened the meeting ... Arindam Dasgupta, Deputy Director, Division of New Drug Study Integrity, Office of Translational Sciences, shares background ... Sriram Subramaniam, CDER Office of Clinical Pharmacology, discusses Ruben Ayala, CDER Office Translational Sciences, discusses