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

✍ Scribed by Richard K. Burdick, David J. LeBlond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky, Lanju Zhang (auth.)

• Publisher: Springer International Publishing
• Year: 2017
• Tongue: English
• Leaves: 383
• Series: Statistics for Biology and Health
• Edition: 1
• Category: Library

✦ Synopsis

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 scientists who are responsible for performing statistical analyses within a CMC environment. Basic statistical concepts are addressed in Chapter 2 followed by applications to specific topics related to development and manufacturing. The mathematical level assumes an elementary understanding of statistical methods. The ability to use Excel or statistical packages such as Minitab, JMP, SAS, or R will provide more value to the reader.

The motivation for this book came from an American Association of Pharmaceutical Scientists (AAPS) short course on statistical methods applied to CMC applications presented by four of the authors. One of the course participants asked us for a good reference book, and the only book recommended was written over 20 years ago by Chow and Liu (1995). We agreed that a more recent book would serve a need in our industry.

Since we began this project, an edited book has been published on the same topic by Zhang (2016). The chapters in Zhang discuss statistical methods for CMC as well as drug discovery and nonclinical development. We believe our book complements Zhang by providing more detailed statistical analyses and examples.

✦ Table of Contents

Front Matter....Pages i-xi
Introduction....Pages 1-9
Statistical Methods for CMC Applications....Pages 11-113
Process Design: Stage 1 of the FDA Process Validation Guidance....Pages 115-154
Process Qualification: Stage 2 of the FDA Process Validation Guidance....Pages 155-172
GMP Monitoring and Continuous Process Verification: Stage 3 of the FDA Process Validation Guidance....Pages 173-191
Analytical Procedures....Pages 193-225
Specifications....Pages 227-267
Stability....Pages 269-327
Analytical Comparability and Similarity....Pages 329-369
Back Matter....Pages 371-379

✦ Subjects

Statistics for Life Sciences, Medicine, Health Sciences;Pharmaceutical Sciences/Technology;Pharmacy