生物等效性和生物利用度杂志

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Bioequivalence Testing - Industry Perspective

Akula Thukaram Bapuji, Hamsa Lakshmi Venkata Ravikiran, Meda Nagesh, Syed Syedba, Datla Ramaraju, Chinnapu Reddy Jayaprakash Reddy, Sreedasyam Ravinder, Rosi Reddy Yeruva and Sutirtha Roy

Generic drugs are cost effective alternatives for the brand name drugs and the savings are estimated in the average $8 to $10 billion a year. Over the years the prescription of generic drugs has increased from 19% to 60-70% (1984: 19% & 2009- 60-70%). Bioequivalence testing is playing a vital role in generic drug development. But to make a generic drug enter in to a regulated market a company has to meet the stringent criteria in the same way as innovative drugs. But the criterion’s set forth by the regulatories are not always very descriptive and entrepreneur friendly. The prevailing fi erce competition also makes the manufacturers to keep low prices. In order to keep the tight price schedule for generic drugs one must have a clear picture on bioequivalence studies from industry perspective. There are some issues constantly faced by the industry for proper conduct of the BA/BE studies. The review article describes current regulatory requirements from various regulatory agencies and its impact on industry while designing a bioequivalence study and also highlights some of the common areas, which need to be addressed or commented upon. It is the time for industry to partner with regulatories to make bioequivalence studies and intern development of generic drugs more cost effective.