FDA response during today’s meeting on …

“Understanding How the Public Perceives and Values Pharmaceutical Quality” link

During today’s presentation ( @ 1:58), responding to a question from the floor concerning drug dissolution methods at the FDA, Dr. Cindy Buhse stated that they use USP methods. Unfortunately, Dr. Buhse does not realize that USP methods are based on non-validated/non-qualified (hence non-GMP compliant) dissolution testers. These are the most commonly recommended, i.e., paddle and basket apparatuses. Including a test or tester in the USP does not make it valid or qualified. Validation requires scientific/experimental evidence showing that the testers are good/fit for the intended purpose, which these testers lack.

Scientific studies have clearly shown that these testers do not, and cannot, provide relevant and valid results. It would, therefore, be requested that all the results obtained using these testers should be considered null and void and be removed from product quality evaluations. Furthermore, it should be noted that Citizen Petition is under consideration at the FDA requesting the withdrawal of these testers and corresponding tests from regulatory use (link).

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