论文信息 - Maximizing the Role of Physiologically Based Oral Absorption Modeling in Generic Drug Development

Maximizing the Role of Physiologically Based Oral Absorption Modeling in Generic Drug Development

Physiologically based Oral Absorption Modeling has been gaining traction in the biopharmaceutics aspects of drug product development as a tool to guide formulation development, Quality by Design (QbD), food effect prediction, effect of acid reducing agents, SUPAC activities and influence label language. This opinion piece is intended to provide a perspective on the potential applications of oral absorption modeling in guiding formulation development, bioequivalence predictions and support regulatory interactions in development of generic drug products. This article is protected by copyright. All rights reserved.

Amitava Mitra | A. Mitra

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