Journal :   Asian Journal of Research in Chemistry

Volume No. :   7

Issue No. :  1

Year :  2014

Pages :   99-102

ISSN Print :  0974-4169

ISSN Online :  0974-4150


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Forced Degradation Study: An Important Tool in Drug Development



Address:   AB Roge1*, PS Tarte1, MM Kumare1, Dr. G R Shendarkar2, Dr. S M Vadvalkar3
1Research Scholar, CRPS, Nanded Pharmacy College, Nanded
2Associate Professor, Nanded Pharmacy College, Nanded
3Head, CRPS, Nanded Pharmacy College, Nanded
*Corresponding Author
DOI No:

ABSTRACT:
Forced degradation studies are used to facilitate the development of analytical methodology, to gain a better understanding of active pharmaceutical ingredient (API) and drug product (DP) stability, and to provide information about degradation pathways and degradation products. The objective of the review article is to furnish comprehensive portrayal of the forced degradation studies as per the regulatory guidelines that are associated with various regulatory agencies. This article recapitulates the collective views of industry practices on the topic of forced degradation studies. This article reiterates a practical interpretation and summary of the available guidance and some suggestions for best practices for conducting forced degradation studies
KEYWORDS:
Active pharmaceutical ingredient (API), Drug product (DP), Forced Degradation, ICH, FDA guidance, Validation, Method Development.
Cite:
AB Roge, PS Tarte, MM Kumare, G R Shendarkar, S M Vadvalkar. Forced Degradation Study: An Important Tool in Drug Development. Asian J. Research Chem 7(1): January 2014; Page 99-102.
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