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USFDA Guidelines Discussions on - FD Guidelines, SUPAC, 21 CFR PART 11, FDA Bio-equivalence, Integrity, Stability Guidelines and etc.
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This guidance provides recommendations to sponsors and applicants2 submitting bioavailability (BA) information for drug products in investigational new drug applications (INDs), new drug applications (NDAs), and NDA supplements.

This guidance contains recommendations on how to meet the BA requirements set forth in 21 CFR part 320 as they apply to dosage forms intended for oral administration. These dosage forms include tablets, capsules, solutions, suspensions, conventional (e.g., immediate-release (IR) drug products) and modified-release (MR) (e.g., extended-release (ER), delayed-release (DR)) drug products.

The guidance is also applicable to non-orally administered drug products, when it is appropriate to rely on systemic exposure measures to determine the BA of a drug (e.g., transdermal delivery systems and certain vaginal, rectal, and nasal drug products).

The guidance provides recommendations on conducting BA studies during the investigational period for a drug intended to be submitted for approval in an NDA and bioequivalence (BE) studies during the postapproval period for certain changes to drug products with an approved NDA.

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