http://www.sciencemag.org/cgi/content/full/326/5951/370 A generic drug product is one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use. I. Important facts about generics and generic drug appli...
8. Please add justified specifications for the full range of particle sizedistribution. Alternatively,...
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In the case where a generic drug product uses a different polymorphic form from the RLD, the drug substance should be subjected to stress testing to evaluate the physiochemical changes of the polymorphic form because different polymorphic forms may exhibit different stability characteristics. Forced ...