Comparative Risk Assessment of Formulation Changes in Generic Drug Products: A Pharmacology/Toxicology Perspective.
نویسندگان
چکیده
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.
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ورودعنوان ژورنال:
- Toxicological sciences : an official journal of the Society of Toxicology
دوره 146 1 شماره
صفحات -
تاریخ انتشار 2015