Dear Fellow Pharmaceutical Scientists:
FDA recently published revised guidance on "Statistical Approaches to Establishing Bioequivalence"
Statistical Approaches to Establishing Bioequivalence
| U.S. Food and Drug Administration |
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| Statistical Approaches to Establishing Bioequivalence |
| GUIDANCE DOCUMENT Not for implementation. Contains non-binding recommendations. Requirements for submitting bioavailability (BA) and bioequivalence (BE) data in investigational new drugs (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements; the definitions of BA and BE; and the types of in vitro and in vivo studies that are appropriate to measure BA and establish BE are set forth in part 320 (21 CFR part 320). |
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please feel free to use this forum to discuss your views and raise any points that are of interest for the benefit of our pharmaceutical scientists community in general.
Happy Holiday s to each one of you from your community leadership.
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Prasad Tata M. Pharm, Ph.D., FCP
Sr. Director-PK/BE
American Regent, Inc.
Princeton NJ
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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