FDA releases Guidance for Industry on Bioavailability Studies Submitted in NDAs or INDs — General Considerations

April 18, 2022

FDA issued a final guidance to drug sponsors on conducting and submitting bioavailability (BA) studies for drug products in investigational new drug applications (INDs), new drug applications (NDAs), and NDA supplements. Determining the BA of formulations is important during the life cycle of drug products and aids in the FDA’s evaluation of the safety and effectiveness of a product in an IND, NDA, or NDA supplement. To determine the safety and efficacy of a drug product for the proposed indication, the FDA reviews all submitted information, including BA data, exposure-response evaluations, and clinical trial results.

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 post-approval period for certain changes to drug products with an approved NDA.

Read the snapshot for the highlights or listen to the podcast to hear from an expert on FDA’s final guidance on conducting and submitting bioavailability studies for a drug product.

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