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. áThe 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.áThe mathematical level assumes an elementary understanding of statistical methods. áThe 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. áOne 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). áWe agreed that a more recent book would serve a need in our industry. áSince we began this project, an edited book has been published on the same topic by Zhang (2016). áThe chapters in Zhang discuss statistical methods for CMC as well as drug discovery and nonclinical development. áWe believe our book complements Zhang by providing more detailed statistical analyses and examples.