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Toxicol Sci 2015 Jul;146(1):2-10

Comparative risk assessment of formulation changes in generic drug products: a pharmacology/toxicology perspective.

Rayavarapu S, Braithwaite E, Dorsam R, Osterhout J, Furlong LA, Shetty D, Peters JR

Abstract

This review highlights general toxicology concerns caused by formulation differences between generic and innovator drugs. It underscores the importance of a scientific, clinically oriented, evidence-based comparative safety evaluation procedure for generic drugs and discusses representative case studies from a pharmacology-toxicology perspective. For consideration by generic drug industry stakeholders, this article provides an overview of comparative risk assessments for generic drug products.

Category: Journal Article, Review
PubMed ID: #26101235 DOI: 10.1093/toxsci/kfv074
Includes FDA Authors from Scientific Area(s): Drugs
Entry Created: 2016-02-19
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