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

• Κύριοι συγγραφείς: Burdick, Richard K. (Συγγραφέας), LeBlond, David J. (Συγγραφέας), Pfahler, Lori B. (Συγγραφέας), Quiroz, Jorge (Συγγραφέας), Sidor, Leslie (Συγγραφέας), Vukovinsky, Kimberly (Συγγραφέας), Zhang, Lanju (Συγγραφέας)
• Συγγραφή απο Οργανισμό/Αρχή: SpringerLink (Online service)
• Μορφή: Ηλεκτρονική πηγή Ηλ. βιβλίο
• Γλώσσα: English
• Έκδοση: Cham : Springer International Publishing : Imprint: Springer, 2017.
• Σειρά: Statistics for Biology and Health,
• Θέματα: Pharmacy.; Statistics.; Pharmaceutical technology.; Statistics for Life Sciences, Medicine, Health Sciences.; Pharmaceutical Sciences/Technology.

This book examines statistical techniques that are critically important to Chemistry, Manufacturing, and Control (CMC) activities. Statistical methods are presented with a focus on applications unique to the CMC in the pharmaceutical industry. The target audience consists of statisticians and other...

Πίνακας περιεχομένων:

• 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.