{
"item_title" : "Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry",
"item_author" : [" Richard K. Burdick", "David J. Leblond", "Lori B. Pfahler "],
"item_description" : "Chapter 1. Introduction.- Chapter 2. Statistical Methods for CMC Applications.- Chapter 3. Process Design: Stage 1 of the FDA Process Validation Guidance.- Chapter 4. Process Qualification: Stage 2 of the FDA Process Validation Guidance.- Chapter 5. GMP Monitoring and Continuous Process Verification: Stage 3 of the FDA Process Validation Guidance.- Chapter 6. Analytical Procedures.- Chapter 7. Specifications.- Chapter 8. Stability.- Chapter 9. Analytical Comparability and Similarity.",
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Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry
Overview
Chapter 1. Introduction.- Chapter 2. Statistical Methods for CMC Applications.- Chapter 3. Process Design: Stage 1 of the FDA Process Validation Guidance.- Chapter 4. Process Qualification: Stage 2 of the FDA Process Validation Guidance.- Chapter 5. GMP Monitoring and Continuous Process Verification: Stage 3 of the FDA Process Validation Guidance.- Chapter 6. Analytical Procedures.- Chapter 7. Specifications.- Chapter 8. Stability.- Chapter 9. Analytical Comparability and Similarity.
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Details
- ISBN-13: 9783319501840
- ISBN-10: 3319501844
- Publisher: Springer
- Publish Date: February 2017
- Dimensions: 9.21 x 6.14 x 0.88 inches
- Shipping Weight: 1.59 pounds
- Page Count: 379
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