Impact of ICH Q11 Questions and Answers on the Outcome of Active Pharmaceutical Ingredient Starting Material Proposal Acceptance by ICH Regulatory Members

Steven Tymonko,Brenda J. Burke, Jean-Philippe Crochard,Olivier Dirat,Kenneth J. Fraunhoffer, Cristian Harrison, Timothy Kramer,Heewon Lee, Vlad Liberman,Kanwar P. S. Sidhu, Randi Smith,Neil A. Strotman,Nil Tandogan, Alan Triman, Haitao Zhang

Organic Process Research & Development（2024）

Cited 1|Views30

Key words

starting materials,manufacturing,impurities,pharmaceuticals,quality management

AI Read Science

Must-Reading Tree

Example

Generate MRT to find the research sequence of this paper

Chat Paper

Summary is being generated by the instructions you defined