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
An Insight into the Impact of Thermal Process on Dissolution Profile and Physical Characteristics of Theophylline Tablets Made through 3D Printing Compared to Conventional Methods
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DOI: 10.3390/biomedicines10061335
Abstract: The dissolution profile is of great importance in drug delivery and is affected by the manufacturing method. Thus, it is important to study the influence of the thermal process on drug release in emerging technologies… read more here.
Keywords: dissolution; dissolution profile; release; drug ... See more keywords