INTERCHANGEABILITY OF MULTISOURCE PHARMACEUTICAL PRODUCT A REVIEW
Journal Title: International Research Journal of Pharmacy (IRJP) - Year 2011, Vol 2, Issue 6
Abstract
Multisource (generic) drug products may contain drug substances and drug products that meet compendial monograph standards of strength, quality, purity, and identity. Pharmaceutical equivalence per se does not ensure equivalent drug product performance as demonstrated by bioequivalence, nor does it ensure therapeutic equivalence. This Stimuli article examines pharmaceutical equivalence and suggests that multisource drug products that meet compendial monograph requirements may not be pharmaceutical equivalents and/or may not have the same drug product performance.
Authors and Affiliations
Sharad Sharma , Nitin Dashputre , Satyavan Dhavale , Mitul Chatterjee , Sanjay Shrivastava
Keywords
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