FORCED DEGRADATION STUDIES: PRACTICAL APPROACH - OVERVIEW OF REGULATORY GUIDANCE AND LITERATURE FOR THE DRUG PRODUCTS AND DRUG SUBSTANCES
Journal Title: International Research Journal of Pharmacy (IRJP) - Year 2013, Vol 4, Issue 5
Abstract
The Objective of the review article is to give a detailed description of the forced degradation studies as per the regulatory guidelines that are associated with various regulatory agencies. This article summarizes the collective views of industry practices on the topic of forced degradation studies. The article includes an overview of existing guidance’s and literature for best practices.
Authors and Affiliations
Kishore Hotha, Satti Phani Reddy, L. K. Ravindranath
Keywords
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- EP ID EP125538
- DOI 10.7897/2230-8407.04517
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