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Individual BE Replicate Study Design To Be Analyzed Over Two Years By FDA

Executive Summary

FDA is planning to conduct a two-year evaluation of its recommended replicate design method to determine whether a transition away from average bioequivalence criterion and towards individual and population BE criteria should occur.

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Deponit BE/BA Submissions Supported By FDA Guidances - Schwarz Pharma

Recent FDA guidances on bioequivalence support Schwarz Pharma's argument that it has submitted adequate BE and bioavailability data for its transdermal nitroglycerin product Deponit under the Drug Efficacy Study Implementation program, Schwarz argued in recent correspondence to FDA.

Deponit BE/BA Submissions Supported By FDA Guidances - Schwarz Pharma

Recent FDA guidances on bioequivalence support Schwarz Pharma's argument that it has submitted adequate BE and bioavailability data for its transdermal nitroglycerin product Deponit under the Drug Efficacy Study Implementation program, Schwarz argued in recent correspondence to FDA.

FDA Locally Active Drug BA/BE Guidances Slated for Release In About A Year

Four FDA guidances on drug bioavailability and bioequivalence, including three focused on "locally active drug products," are expected to be issued "in the next year or so," Center for Drug Evaluation and Research Deputy Director for Pharmaceutical Science Roger Williams, MD, told an International Generic Pharmaceutical Alliance conference in Rome June 5.

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