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 the use of drug dissolution methods at the FDA, Dr. Cindy Buhse stated that they use USP methods. Unfortunately, it seems that Dr. Buhse does not realize that USP methods are based on non-validated/non-qualified (hence non-GMP compliant) dissolution testers in particular most commonly recommended ones i.e. paddle and basket apparatuses. Inclusion of 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 products quality evaluations. Furthermore, it should be noted that there is Citizen Petition under consideration at the FDA requesting the withdrawal of these testers, and corresponding tests, from the regulatory use (link).

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