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Overview of Drug Development and Statistical Tools for Manufacturing and Testing

  • Chapter
Nonclinical Statistics for Pharmaceutical and Biotechnology Industries

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

Abstract

An essential part of the application for marketing approval of a new drug or therapeutic biological product submitted to regulatory authorities is the Chemistry Manufacturing and Controls (CMC) section. It presents the sponsor company’s documentation of sufficient scientific and engineering knowledge to manufacture the product with consistent quality that provides defined clinical efficacy with an acceptable safety profile. The CMC section includes three main parts: (1) Chemical Development (synthesis of a new molecular entity (NME), purification of a new biologic entity (NBE); (2) Pharmaceutical Development (comprised of formulation and process development); (3) Analytical Development (analytical methods for physical, chemical, biological characterization). Specifications are established during development and constitute an important part of the CMC section in defining the product’s quality requirements. This chapter provides an overview of the drug development process, and some statistical tools useful in support of CMC studies. This chapter aims to set the stage for the subsequent 11 chapters in the CMC section of this book which delve in greater detail into important CMC related statistical topics.

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Notes

  1. 1.

    A division of NMEs into large and small molecules is commonly found in the CMC literature. Small molecules are the classical drug mainly chemically synthesized. They are easily manufactured as tablets or capsules. Biological NMEs such as monoclonal antibodies are proteins that are either identical to or closely match endogenous proteins that play a key role in a disease process. They are manufactured as an injection or an infusion typically. Although small molecule drugs still make up 90 % of the drugs on the market, large molecule biological products are becoming increasingly more important.

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Authors and Affiliations

  1. Statistical Sciences Group, GlaxoSmithKline Pharmaceuticals, Upper Providence, PA, 19426, USA

    John Peterson

  2. Nonclinical Statistics and Computing, Janssen R&D LLC, Raritan, NJ, 08869, USA

    Stan Altan

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  1. John Peterson
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  2. Stan Altan
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Correspondence to John Peterson .

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Editors and Affiliations

  1. Nonclinical Statistics, Abbvie Inc, North Chicago, Illinois, USA

    Lanju Zhang

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Peterson, J., Altan, S. (2016). Overview of Drug Development and Statistical Tools for Manufacturing and Testing. In: Zhang, L. (eds) Nonclinical Statistics for Pharmaceutical and Biotechnology Industries. Statistics for Biology and Health. Springer, Cham. https://doi.org/10.1007/978-3-319-23558-5_15

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