Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry

1. Introduction
Richard K. Burdick, David J. LeBlond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky, Lanju Zhang

2. Statistical Methods for CMC Applications
Richard K. Burdick, David J. LeBlond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky, Lanju Zhang

3. Process Design: Stage 1 of the FDA Process Validation Guidance
Richard K. Burdick, David J. LeBlond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky, Lanju Zhang

4. Process Qualification: Stage 2 of the FDA Process Validation Guidance
Richard K. Burdick, David J. LeBlond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky, Lanju Zhang

5. GMP Monitoring and Continuous Process Verification: Stage 3 of the FDA Process Validation Guidance
Richard K. Burdick, David J. LeBlond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky, Lanju Zhang

6. Analytical Procedures
Richard K. Burdick, David J. LeBlond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky, Lanju Zhang

7. Specifications
Richard K. Burdick, David J. LeBlond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky, Lanju Zhang

8. Stability
Richard K. Burdick, David J. LeBlond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky, Lanju Zhang

9. Analytical Comparability and Similarity
Richard K. Burdick, David J. LeBlond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky, Lanju Zhang

Keywords: Statistics, Statistics for Life Sciences, Medicine, Health Sciences, Pharmaceutical Sciences/Technology, Pharmacy