US FDA: Data Integrity for In Vivo Bioavailability and Bioequivalence Studies

The draft document “Data Integrity for In Vivo Bioavailability and Bioequivalence Studies” was published on the US FDA website at the beginning of April 2024. The document aims to assist applicants and marketing authorisation holders on achieving and maintaining data integrity for the clinical and bioanalytical part of bioavailability (BA) and bioequivalence (BE) studies for INDs (investigational new drug applications) submission, NDAs (new drug applications), ANDAs (abbreviated new drug applications), for the bioanalytical part of the clinical studies of BLAs (biologic licence applications) as well as for supplements and amendments to these marketing authorisations.

In addition, the recommendations in this guidance apply to the bioanalytical portion of nonclinical studies. The FDA also encourages applicants and testing sites to take these recommendations into consideration when conducting in vitro, pharmacology and toxicology studies.

SOURCES:

https://www.fda.gov/media/177404/download