Volume No. :   3

Issue No. :  4

Year :  2013

ISSN Print :  2231-5683

ISSN Online :  2231-5691


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Forced Degradation Study: An Important Tool in Drug Development

Address:   A.B. Roge1, P.S. Tarte1, M.M. Kumare1, Dr. G.R. Shendarkar2, Dr. S.M. Vadvalkar2
1Research Scholar, CRPS, Nanded Pharmacy College, Nanded
2Associate Professor, Nanded Pharmacy College, Nanded
*Corresponding Author

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.
Active pharmaceutical ingredient (API), Drug product (DP), Forced Degradation, ICH, FDA guidance, Validation, Method Development
A.B. Roge, P.S. Tarte, M.M. Kumare, G.R. Shendarkar, S.M. Vadvalkar. Forced Degradation Study: An Important Tool in Drug Development. Asian J. Pharm. Res. 3(4): Oct. - Dec.2013; Page 198-201.
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