Complex Product Characterization Analysis Session 2c

Summary

A presentation and panel assess analytical methods currently considered most useful and how to better develop these ... Yiwei Li from CDER's Office of Pharmaceutical Quality shares a case study, an introduction to Iron Colloid Drug Welcome to this lecture on Biopharmaceutical Structure and Asif Rasheed from the Office of Pharmaceutical Quality discusses common issues and challenges for Rachel Dunn, PhD, Director of the Division of Pharmaceutical FDA discusses additional topics in Presenters Yan Wang, Bin Qin, Vidula Kolhatkar, and Bing Cai answer audience questions. Learn more at ... Bryan Newman, Denise Conti, Kimberly Witzmann, Tian Ma, Fang Yuan, and Bhagwant Rege respond to audience questions. When a single agent is overloaded, the answer is usually decomposition: split the problem so each part has narrower tools and ... Xiajing (Jean) Gong from CDER Office Generic Drugs' Division of Quantitative Methods and Modeling discusses ... Xiaoming Xu from the CDER Office of Pharmaceutical Division of Deyi Zhang from the Office of Research and Standards in the Office of Generic Drugs covers Active Pharmaceutical Ingredient ...