Author: [AUTHOR] Published on 4/22/2022 1:00:00 PM
US Food and Drug Administration Announces Availability of a Final Guidance Entitled Bioavailability Studies Submitted in NDAs or INDs – General Considerations
On April 15, 2022, the US Food and Drug Administration (FDA) announced the availability of a final guidance for industry entitled Bioavailability Studies Submitted in NDAs or INDs -- General Considerations. This final guidance provides recommendations to sponsors and applicants submitting bioavailability (BA) information for drug products in investigational new drug applications (INDs), new drug applications (NDAs), and NDA supplements.
BA is defined as the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action. BA data provide an estimate of the amount of the drug absorbed as well as information related to the pharmacokinetics of the drug, the effects of food on the absorption of the drug, and dose proportionality or linearity in the pharmacokinetics of the active moieties.
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). In addition, 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 studies during the post-approval period for certain changes to drug products with an approved NDA.
The “Bioavailability Studies Submitted in NDAs or INDs – General Considerations” guidance is available at: https://go.usa.gov/xu26A. Please refer to the final guidance for more details. To support transparent communication and dissemination of FDA guidance documents, FDA also provides Guidance Snapshots and podcasts as communication tools to provide highlights from guidance documents using visuals and plain language. Please find the Guidance Snapshot and podcast for the Bioavailability Studies Submitted in NDAs or INDs – General Considerations guidance here: https://www.fda.gov/drugs/guidances-drugs/guidance-snapshot-pilot.
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This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.
