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Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry
Chapter 1. Introduction.- Chapter 2. Statistical Methods for CMC Applications.- Chapter 3. Process Stage 1 of the FDA Process Validation Guidance.- Chapter 4. Process Stage 2 of the FDA Process Validation Guidance.- Chapter 5. GMP Monitoring and Continuous Process Stage 3 of the FDA Process Validation Guidance.- Chapter 6. Analytical Procedures.- Chapter 7. Specifications.- Chapter 8. Stability.- Chapter 9. Analytical Comparability and Similarity.
392 pages, Paperback
Published February 22, 2017
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