Description
This guidance provides recommendations to sponsors and/or applicants planning to conduct food-effect bioavailability (BA) and fed bioequivalence (BE) studies for orally administered drug products as part of investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements to these applications.
Scope & Applicability
Product Classes
7conventional (e.g., immediate-release (IR) drug products); new IR drug products developed via the pathway under section 505(b)(1)
modified-release (MR) (e.g., extended-release (ER), delayed-release (DR)) drug products; Characterizing the Effects of Alcoholic Beverages on MR Drug Products; alcohol-induced, dose dumping of MR drug products
highly soluble and highly permeable drug substances
The drug product identified by the applicant for comparison; Comparison of ANDA product to RLD for pH adjuster differences
Reference Listed Drug used as the basis for an ANDA submission.
labeling of certain drug products (e.g., controlled-release capsules containing beads).
labeling for certain oral solution products (e.g., cyclosporine oral solution, modified).
Stakeholders
3Individuals who do not have the disease or condition of interest
Entity responsible for submitting applications under section 524B
Entity submitting development data and knowledge; Entity performing the work process for change
Regulatory Context
Attributes
6Cmax may be more informative for safety
time to reach peak exposure
High solubility and high permeability
approximately 50 percent of total caloric content of the meal
approximately 800 to 1000 calories
AUC or Cmin may correlate with efficacy
Identified Hazards
Hazards
1Risk caused by failure of a drug's release mechanism
Related CFR Sections (2)
- 21CFR314.50§ 314.50 Content and format of an NDA.
NDAs and supplements to approved NDAs are required to be submitted in the form and contain the information, as appropriate for the particular submission, required under this section. Three copies of the NDA are required: An archival copy, a review copy, and a field copy. An NDA for a new chemical enRead full regulation →
- 21CFR314.94§ 314.94 Content and format of an ANDA.
ANDAs are required to be submitted in the form and contain the information required under this section. Three copies of the ANDA are required, an archival copy, a review copy, and a field copy. FDA will maintain guidance documents on the format and content of ANDAs to assist applicants in their prepRead full regulation →
See Also (8)
- Final In Vivo Bioavailability-Bioequivalence Studies- Analytical (Status: Final)
- Bioanalytical Method Validation Guidance for Industry (Status: Final)
- Format and Content of the Clinical and Statistical Sections of an Application (Status: Final)
- Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations (Status: Draft)
- Bioavailability Studies Submitted in NDAs or INDs – General Considerations (Status: Final)
- Alternate Source of the Active Pharmaceutical Ingredient in Pending ANDAs: Guidance for Industry (Status: Final)
- Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications (Status: Final)
- Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence) Studies: Guidance for Industry and Investigators (Status: Final)