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

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

Part of the Statistics for Biology and Health book series (SBH)

Table of contents

  1. Front Matter
    Pages i-xi
  2. Richard K. Burdick, David J. LeBlond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky et al.
    Pages 1-9
  3. Richard K. Burdick, David J. LeBlond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky et al.
    Pages 11-113
  4. Richard K. Burdick, David J. LeBlond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky et al.
    Pages 115-154
  5. Richard K. Burdick, David J. LeBlond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky et al.
    Pages 155-172
  6. Richard K. Burdick, David J. LeBlond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky et al.
    Pages 173-191
  7. Richard K. Burdick, David J. LeBlond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky et al.
    Pages 193-225
  8. Richard K. Burdick, David J. LeBlond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky et al.
    Pages 227-267
  9. Richard K. Burdick, David J. LeBlond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky et al.
    Pages 269-327
  10. Richard K. Burdick, David J. LeBlond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky et al.
    Pages 329-369
  11. Back Matter
    Pages 371-379

About this book

Introduction

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.

Keywords

Analytical Methods Biosimilarity CMC Statistics Chemistry, Manufacturing and Controls FDA Guidance Pharmaceutical Manufacturing Process Verification Quality by Design Stability Studies

Authors and affiliations

  • Richard K. Burdick
    • 1
  • David J. LeBlond
    • 2
  • Lori B. Pfahler
    • 3
  • Jorge Quiroz
    • 4
  • Leslie Sidor
    • 5
  • Kimberly Vukovinsky
    • 6
  • Lanju Zhang
    • 7
  1. 1.Elion LabsLouisvilleUSA
  2. 2.CMC StatisticsWadsworthUSA
  3. 3.Merck & Co., Inc.TelfordUSA
  4. 4.Merck & Co., Inc.KenilworthUSA
  5. 5.BiogenCambridgeUSA
  6. 6.PfizerOld SaybrookUSA
  7. 7.Nonclinical Statistics, Abbvie Inc.North ChicagoUSA

Bibliographic information

  • DOI https://doi.org/10.1007/978-3-319-50186-4
  • Copyright Information Springer International Publishing AG 2017
  • Publisher Name Springer, Cham
  • eBook Packages Mathematics and Statistics
  • Print ISBN 978-3-319-50184-0
  • Online ISBN 978-3-319-50186-4
  • Series Print ISSN 1431-8776
  • Series Online ISSN 2197-5671
  • Buy this book on publisher's site