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USFDA Guidance: Handling and Retention of Bioavailability (BA) & Bioequivalence (BE) Testing Samples

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research updated and released the draft guidance "Handling and Retention of BA and BE Testing Samples" earlier today (27 March 2024).

The purpose of this guidance is to provide recommendations for applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs), including supplemental applications, and contract research organizations regarding the handling of reserve samples in bioavailability (BA) and bioequivalence (BE) studies, as required by and recommendations on what each party should do in relation to reserve samples.

The guidance highlights:

  1. How the test article (T) and reference standard (RS) for BA and BE studies should be distributed to the testing sites,

  2. How testing sites should randomly select samples for testing and material to maintain as reserve samples,

  3. Addresses on how to retain reserve samples of sufficient quantity to permit FDA to perform five times all the release tests required in an application or supplemental application

  4. Describes the conditions under which the Agency does not generally intend to take enforcement action against an applicant or CRO for retaining less than the number of reserve samples of the test article and reference standard that were used in the BA or BE study.

  5. Clarifying recommendations related to certain other relevant requirements.

The study sponsor and/or drug manufacturer should clarify to the testing sites whether reserve samples are required to be retained and it is recommended that the study protocol and study report include:

  • the method for random selection of the reserve samples;

  • the testing site staff responsible for selecting the reserve samples for retention;

  • the total quantity of reserve samples; the number of shipments of study drug (T and RS) to each testing site;

  • the number of reserve samples from each shipment.

This information will help support evaluation of the study’s integrity. Specific compliance policies are applied to all reserve samples for BA and BE studies, including reserve samples from previously completed BA or BE studies.

Click this LINK to know more on topics such as Sampling Techniques, Retention for Multiple Shipments, Batches, and Studies etc.


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