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
Generic Product Lifecycle Model: A Holistic and Adaptable Approach for Multi-Disciplinary Product–Service Systems
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DOI: 10.3390/app11104516
Abstract: The linear economic model behind contemporary product lifecycle representations contradicts planetary boundaries and the idea of sustainability. At the same time, Circular Economy (CE) driven models lack consideration of profound technological insights. Based on observations… read more here.
Keywords: generic product; product lifecycle; product; lifecycle ... See more keywords
Effect of Excipients on the Quality of Drug Formulation and Immediate Release of Generic Metformin HCl Tablets
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DOI: 10.3390/ph16040539
Abstract: Generic medications are bioequivalent to brand-name medications, but the quality and purity of generic medications are still debatable. The aim of this study was to compare the generic product of metformin (MET) to its branded… read more here.
Keywords: generic product; microscopy; product; release ... See more keywords