USE OF PROCESS ANALYTICAL TECHNOLOGY (PAT) IN SMALL MOLECULE DRUG SUBSTANCE REACTION DEVELOPMENT
Author:
Affiliation:
1. Product Development; Bristol-Myers Squibb; New Brunswick NJ USA
Publisher
John Wiley & Sons, Inc.
Link
http://onlinelibrary.wiley.com/wol1/doi/10.1002/9781119600800.ch42/fullpdf
Reference50 articles.
1. Guidance for Industry PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance 2004
2. Monitoring and Quantification of Omeprazole Synthesis Reaction by In-Line Raman Spectroscopy and Characterization of the Reaction Components
3. Pilot Plant Preparation of an αvβ3 Integrin Antagonist. Part 1. Process Research and Development of a (S)-β-Amino Acid Ester Intermediate: Synthesis via a Scalable, Diastereoselective Imino-Reformatsky Reaction
4. Infrared Spectroscopy in Aqueous Solution: Difficulties and Accuracy of Water Subtraction
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