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Clinical Endpoint Bioequivalence Study

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FDA Bioequivalence Standards

Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series ((AAPS,volume 13))

Abstract

The goal of the clinical endpoint bioequivalence study is to perform a comparison of clinical effects of a test and reference drug in order to infer bioequivalence. The clinical endpoint bioequivalence study is a complex compromise method of determining bioequivalence of products that cannot be evaluated by means of a pharmacokinetic or pharmacodynamic study, or, in some cases, an in vitro study. A clinical study is subject to a very high degree of variability and requires a careful consideration of all aspects of design and data analysis. This chapter discusses the background and special considerations of the clinical endpoint bioequivalence study. Some case examples are discussed in order to highlight special considerations that must go into the development of a protocol for a clinical endpoint bioequivalence study.

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Notes

  1. 1.

    Op. Cit. (2009) Generic drugs—safe, effective, and affordable. Dermatol Ther 22(3): 229–240.

  2. 2.

    Op. Cit. (2010) Generic drug product development: international regulatory requirements for bioequivalence. In: Kanfer I, Shargel L (eds). Informa Healthcare, USA, Inc., New York, NY.

  3. 3.

    Ibid.

  4. 4.

    Op. Cit. (1999), JAMA 282:790–795.

  5. 5.

    Ibid.

  6. 6.

    Op. Cit. (2009) Hepatology 50(6):2014–2021.

  7. 7.

    Op. Cit. (2009) Hepatology 50(6):2019.

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Authors and Affiliations

  1. Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA

    John R. Peters

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  1. John R. Peters
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Correspondence to John R. Peters .

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Editors and Affiliations

  1. Office of Pharmaceutical Science, U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Science, Silver Spring, Maryland, USA

    Lawrence X. Yu

  2. U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Generic Drugs, Silver Spring, Maryland, USA

    Bing V. Li

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Peters, J.R. (2014). Clinical Endpoint Bioequivalence Study. In: Yu, L., Li, B. (eds) FDA Bioequivalence Standards. AAPS Advances in the Pharmaceutical Sciences Series, vol 13. Springer, New York, NY. https://doi.org/10.1007/978-1-4939-1252-0_10

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