PAT-Facilitated Pharmaceutical Crystallization Development through Mechanistic Understanding
Author:
Affiliation:
1. Gilead Sciences, Inc., Foster City, California 94404, United States
2. Gilead Alberta ULC, Edmonton, Alberta T6S 1A1, Canada
Publisher
American Chemical Society (ACS)
Subject
Condensed Matter Physics,General Materials Science,General Chemistry
Link
https://pubs.acs.org/doi/pdf/10.1021/acs.cgd.0c01171
Reference41 articles.
1. FDA. Pharmaceutical cGMPs for the 21st Century – a Risk-Based Approach, September 2004.
2. USE OF PAT FOR ACTIVE PHARMACEUTICAL INGREDIENT CRYSTALLIZATION PROCESS CONTROL
3. FDA. Pharmaceutical Development, ICH-Q8, September 2009.
4. FDA. Guidance for Industry PAT – A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, September 2004.
5. An Integrated Process Analytical Technology (PAT) Approach for Pharmaceutical Crystallization Process Understanding to Ensure Product Quality and Safety: FDA Scientist’s Perspective
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