Blog — Clinical Pathways

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bioavailability

FDA Releases New Draft Guidance on Data Integrity for In Vivo Bioavailability and Bioequivalence Studies

07/05/2024

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In April 2024, the US Food and Drug Administration (FDA) released a draft guidance for industry titled: Data Integrity for In Vivo Bioavailability and Bioequivalence Studies. The draft guidance explains the difference between data quality and data integrity. While both are necessary to maintain in a clinical study in order to obtain reputable data, they each have important differences.

Bioavailability Studies for NDA or IND Guidance

06/07/2022

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The US Food and Drug Administration (FDA) released a guidance “Bioavailability Studies Submitted in NDAs or INDs – General Considerations” in April 2022. Bioavailability (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.”