Generics and discriminatory dissolution tests

Generics are drug products which are considered identical in dose, strength, route of administration, safety, efficacy, and intended use as an innovator’s product. However, generics are different from innovators’ products with regard to formulation and manufacturing attributes. Because of these differences in formulation and manufacturing, it is expected from the generics that they demonstrate that the drug release from their product is similar to those of the corresponding innovators’ product.

This similarity or equivalence in drug release between generic and innovator products is established by conducting bioavailability/bio-equivalence studies. Such bioequivalence studies, in fact, establish that drug release (dissolution) in vivo from both products is the same. A very important point in understanding this principle is that generics strive to achieve similarity of drug release from innovators’ products in vivo having vastly different formulation and manufacturing attributes. Otherwise, generics and innovators’ products would have different bio-availabilities and would not be bioequivalent, Therefore, a difference in formulations or manufacturing attributes, or finding these differences by in vitro dissolution tests, are of no real consequences. Thus, the practice of finding such differences or developing dissolution tests under the terminology of “discriminatory test”, is an erroneous and misguided exercise.

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