How to Handle and Reserve Samples from BA / BE Studies

In April 2024, the draft document "Data Integrity for In Vivo Bioavailability and Bioequivalence Studies" was published on the US FDA website. The document is intended to assist applicants and marketing authorization holders (MAHs) in the area of data integrity for the clinical and bioanalytical part of bioequivalence and bioavailability studies.

In addition, a second guidance for study sponsors and/or drug manufacturers, contract research organizations (CROs), site management organizations (SMOs), clinical investigators, and independent third parties has been published. It is intended to provide recommendations regarding the procedure for handling reserve samples from relevant bioavailability (BA) and bioequivalence (BE) studies. The guidance highlights

  • how the test article and reference standard for BA and BE studies should be distributed to the testing facilities,
  • how testing facilities should randomly select samples for testing and material to maintain as reserve samples, and
  • how the reserve samples should be retained.

More information is available in FDA's draft guideline Handling and Retention of Bioavailability and Bioequivalence Testing Samples.

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