Simplified Model-Dependent and Model-Independent Approaches for Dissolution Profile Comparison for Oral Products: Regulatory Perspective for Generic Product Development
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DOI: 10.1208/s12249-021-02203-7
Abstract: Dissolution profile comparison among different formulations plays a critical role during new drug as well as generic product development. In the generic product development, dissolution profile comparison is a mandate for biowaivers (BCS-based, for lower… read more here.
Keywords: dissolution profile; profile comparison; model; generic product ... See more keywords