| Literature DB >> 26101235 |
Sree Rayavarapu1, Elena Braithwaite2, Robert Dorsam2, James Osterhout2, Lesley-Anne Furlong2, Daiva Shetty2, John R Peters2.
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. Published by Oxford University Press on behalf of the Society of Toxicology 2015. This work is written by US Government employees and is in the public domain in the US.Keywords: excipients; generics; impurities; reference listed drug; residual solvents; toxicity
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Year: 2015 PMID： 26101235 DOI： 10.1093/toxsci/kfv074
Source DB: PubMed Journal: Toxicol Sci ISSN： 1096-0929 Impact factor: 4.849