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Risk-Based Bioequivalence Recommendations for Antiepileptic Drugs

  • Epilepsy (CW Bazil, Section Editor)
  • Published:
Current Neurology and Neuroscience Reports Aims and scope Submit manuscript

Abstract

Purpose of Review

This review summarizes the current FDA practice in developing risk- and evidence-based product-specific bioequivalence guidances for antiepileptic drugs (AEDs).

Recent Findings

FDA’s product-specific guidance (PSG) for AEDs takes into account the therapeutic index of each AED product. Several PSGs for AEDs recommend fully replicated studies and a reference-scaled average bioequivalence (RS-ABE) approach that permit the simultaneous equivalence comparison of the mean and within-subject variability of the test and reference products.

Summary

The PSGs for AEDs published by FDA reflect the agency’s current thinking on the bioequivalence studies and approval standards for generics of AEDs. Bioequivalence between brand and generic AED products demonstrated in controlled studies with epilepsy patients provides strong scientific support for the soundness of FDA bioequivalence standards.

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Authors and Affiliations

  1. Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD, 20993, USA

    Zhichuan Li, Lanyan Fang, Wenlei Jiang, Myong-Jin Kim & Liang Zhao

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  1. Zhichuan Li
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Correspondence to Lanyan Fang.

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Conflict of Interest

Zhichuan Li, Lanyan Fang, Wenlei Jiang, Myong-Jin Kim, and Liang Zhao declare that they have no conflict of interest.

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This article does not contain any studies with human or animal subjects performed by any of the authors.

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This article is part of the Topical Collection on Epilepsy

This article reflects the views of the authors and should not be construed to represent the views or policies of the US Food and Drug Administration (FDA).

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Cite this article

Li, Z., Fang, L., Jiang, W. et al. Risk-Based Bioequivalence Recommendations for Antiepileptic Drugs. Curr Neurol Neurosci Rep 17, 82 (2017). https://doi.org/10.1007/s11910-017-0795-1

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  • DOI: https://doi.org/10.1007/s11910-017-0795-1

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