Journal of Bioequivalence & Bioavailability

Meda Nagesh

Publications

• Research Article
  Bioequivalence Testing - Industry Perspective
  Author(s): Akula Thukaram Bapuji, Hamsa Lakshmi Venkata Ravikiran, Meda Nagesh, Syed Syedba, Datla Ramaraju, Chinnapu Reddy Jayaprakash Reddy, Sreedasyam Ravinder, Rosi Reddy Yeruva and Sutirtha RoyAkula 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.. View More»
  DOI: 10.4172/jbb.1000039

  Abstract PDF