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Statistical Methods for CMC Applications

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

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

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Abstract

In this chapter, we provide statistical methods that are useful in CMC applications. Our goal is to provide a description of these methods without delving deeply into the theoretical aspects. References are provided for the reader who desires a more in depth understanding of the material.

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Author information

Authors and Affiliations

  1. Elion Labs, Louisville, Colorado, USA

    Richard K. Burdick

  2. CMC Statistics, Wadsworth, IL, USA

    David J. LeBlond

  3. Merck & Co., Inc., Telford, PA, USA

    Lori B. Pfahler

  4. Merck & Co., Inc., Kenilworth, NJ, USA

    Jorge Quiroz

  5. Biogen, Cambridge, Massachusetts, USA

    Leslie Sidor

  6. Pfizer, Old Saybrook, Connecticut, USA

    Kimberly Vukovinsky

  7. Nonclinical Statistics, Abbvie Inc., North Chicago, IL, USA

    Lanju Zhang

Authors
  1. Richard K. Burdick
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  2. David J. LeBlond
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  3. Lori B. Pfahler
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  4. Jorge Quiroz
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  5. Leslie Sidor
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  6. Kimberly Vukovinsky
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  7. Lanju Zhang
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Burdick, R.K. et al. (2017). Statistical Methods for CMC Applications. In: Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry. Statistics for Biology and Health. Springer, Cham. https://doi.org/10.1007/978-3-319-50186-4_2

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