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Bioequivalence

A Review of Study Design and Statistical Analysis for Orally Administered Products

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Abstract

Bioequivalence has been the topic of many publications since its development in the late twentieth century for the protection of public health when changing formulations of orally administered products. This review paper describes the international regulations for this purpose and provides an outline of major steps in the development of the bioequivalence two one-sided testing procedure. Study designs and analysis methods used in testing for bioequivalence are also described.

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Notes

  1. To save space we will not display the raw data here, but they are given in full in Patterson and Jones (and are available electronically at http://www.crcpress.com).[6]

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Acknowledgements

The authors are employed by GlaxoSmithKline and Pfizer and gratefully acknowledge the support of their companies.

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Authors and Affiliations

  1. Research and Development, GlaxoSmithKline Pharmaceuticals, 2301 Renaissance Blvd., King of Prussia, PA, 19406, USA

    Scott D. Patterson

  2. Global Research and Development, Pfizer Pharmaceuticals, Sandwich, UK

    Byron Jones

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Correspondence to Scott D. Patterson.

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Patterson, S.D., Jones, B. Bioequivalence. Int J Pharm Med 20, 243–250 (2006). https://doi.org/10.2165/00124363-200620040-00004

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