Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry. 1st ed. 2017

種類:

電子ブック

責任表示:

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

出版情報:

Cham : Springer International Publishing : Imprint: Springer, 2017

著者名:

Burdick, Richard K.

LeBlond, David J.

Pfahler, Lori B.

Quiroz, Jorge.

Sidor, Leslie.

Vukovinsky, Kimberly.

Zhang, Lanju.

SpringerLink (Online service)

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シリーズ名:

Statistics for Biology and Health ;

ISBN:

9783319501864 [3319501860]    

注記:

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.
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 recomm

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