Bioavailability studies submitted in NDAs or INDs: general considerations
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services, issuing body. United States. Food and Drug Administration, issuing body. Center for Drug Evaluation and Research (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, April 2022
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Biological Availability Clinical Trials as Topic Drug Approval Drug Evaluation Investigational New Drug Application United States United States. Department of Health and Human Services United States. Food and Drug Administration
- Genre(s):
- Technical Report
- Abstract:
- 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.3 This guidance does not discuss information for demonstrating BE for drug products in abbreviated new drug applications (ANDAs) and ANDA supplements. In August 2021, the FDA issued a separate draft guidance on this topic entitled Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA. Furthermore, this guidance does not provide recommendations on studies conducted in support of demonstrating comparability or biosimilarity for biological products licensed under section 351 of the Public Health Service Act (see the FDA guidances entitled Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product (December 2016) and Considerations in Demonstrating Interchangeability With a Reference Product (May 2019) for more information). This guidance finalizes the FDA guidance entitled Bioavailability Studies Submitted in NDAs or INDs – General Considerations (February 2019). The February 2019 draft of this guidance revised and replaced the draft guidanceBioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations (March 2014). The FDA considered comments received on the March 2014 guidance when issuing the February 2019 draft of this guidance. The FDA recognizes that this guidance cannot address every issue pertaining to the assessment of BA studies for INDs and NDAs. Therefore, sponsors are encouraged to contact the appropriate review division with specific questions not addressed by this guidance. The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (i, 30 pages)).
- NLM Unique ID:
- 9918452382506676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918452382506676