Cover Image
Read Now

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

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...

Full description

Bibliographic Details
Main Authors: Burdick, Richard K., LeBlond, David J. (Author), Pfahler, Lori B. (Author), Quiroz, Jorge (Author)
Format: eBook
Language:English
Published: Cham Springer International Publishing 2017, 2017
Edition:1st ed. 2017
Series:Statistics for Biology and Health
Subjects:
Pharmaceutical Chemistry
Biostatistics
Pharmacy
Pharmaceutics
Biometry
Online Access:
Collection: Springer eBooks 2005- - Collection details see MPG.ReNa
Table of Contents:
  • 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

Similar Items