Bioavailability and Bioequivalence Studies for Orally Administered Drug Products General Considerations Guidance 2000

This guidance is intended to provide recommendations to sponsors or applicants planning to include BA and BE information for orally administered drug products in the INDs, NDAs, ANDAs, and their supplements. This guidance addresses how to meet the BA and BE requirements set forth in 21 CFR 320 as they apply to dosage forms intended for oral administration. These include tablets, capsules, solutions, suspensions, conventional/immediate release, and modified (extended/ delayed) release drug products. The guidance is also generally applicable to nonorally administered drug products where reliance on systemic exposure measures is suitable to document BA and BE (e.g., transdermal delivery systems and certain rectal and nasal drug products).

This guidance starts with the definitions and a detailed discussion of the terms BA and BE which is then followed by a discussion on the following topics: methods to document BA and BE; comparison of BA measures in BE studies; documentation of BA and BE; and special topics namely food-effect studies, moieties to be measured, long half-life drugs, first point Cmax, orally administered drugs intended for local action and narrow therapeutic range drugs.

This guidance is designed to reduce the need for FDA drug-specific BA/BE guidances. As a result, this guidance replaces a number of previously issued FDA drug-specific guidances which are listed in the Appendix 1 of this guidance.

A concluding remark on the U.S. regulations and guidances is that there are a few pertinent guidances which are at the draft stage that are not covered in this chapter and the reader is strongly encouraged to get familiar with them and follow their progress till issuance of the final version. Probably the most critical ones are the "Exposure-Response" and the "Food-Effect" guidances.

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