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# Comments on Bioavailability Studies Draft Guidance
- URL: https://www.fdaweb.com/comments-on-bioavailability-studies-draft-guidance/
- Published: 2019-05-23T12:00:00.000Z
- Updated: 2026-09-15T01:28:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144177

AstraZeneca says an FDA draft guidance on bioavailability (BA) studies submitted in NDAs and INDs mentions bioequivalence several places in the document. The company’s comment [letter](https://www.regulations.gov/document?D=FDA-2018-D-4367-0007&ref=fdaweb.com) says “if demonstration of bioequivalence is not a requirement, we suggest replacing ‘BE studies’ with ‘BA studies’ in this guidance. It is appreciated that BE principles can be used for evaluation of BA studies as stated in the Background.” AZ also asks FDA to summarize the changes between this proposed guidance and the 2014 guidance it will replace. And it provides specific line-by-line comments.

The International Consortium for Innovation and Quality in Pharmaceutical Development [provides](https://www.regulations.gov/document?D=FDA-2018-D-4367-0006&ref=fdaweb.com) both general and specific technical comments on the draft.