Dear regulatory and pharmaceutical scientists, please note that all dissolution tests described in the USP and/or FDA database lack scientific basis and are invalid for assessing any drug product characteristics, including quality. The recommended testers and associated methods have never been validated and/or qualified for the intended purpose. These tests are conducted as a regulatory requirement, which forces people/industry to use the testers and the methods resulting in false claims regarding the quality of products. To be scientifically valid, the tests must be product-independent, and testers must be validated and qualified for testing products for human use. Please pay attention!

(Links for further details 1, 2)

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