Generic Pharmaceuticals, regulatory aspects, bioequivalence investigation, and perception.
Ravi BhushanJürgen MartensPublished in: Expert opinion on drug safety (2024)
The USP, the USFDA and the units alike internationally should enforce pharmaceutical companies to perform stereoselective investigations on generic APIs to show that their PK/PD parameters are (nearly) equal to the standards set by such units for allowing marketing of that API. This should be provided to professionals in the areas of patient care and every country should enforce such regulations at the time of export and import of generics.
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