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Managing Bioequivalence Studies to Optimize the Quality, Cost, and Speed of Generics Manufacturing

CHAPEL HILL, N.C., Aug. 25, 2011 /PRNewswire/ -- The global generics drug market has grown to $120 billion and with a number of blockbusters set to go off patent, the sector will see even more growth in the coming years. But as organizations involved in generics ramp up their manufacturing efforts, success hinges on the critical bioequivalence studies that are required to bring new generic drugs to market.

Best Practices, LLC conducted a wide-ranging and detailed study to help generics manufacturers identify effective strategies and processes for managing the bioequivalence component of generics development, where quality, cost and speed are all vital success factors. This benchmarking study aims to identify key cost, quality and productivity metrics for the process of conducting bioequivalence studies.

"Pharma Bioequivalence Strategies: Performance Metrics, Processes & Trends" is a new 49-page report that delivers key performance and process benchmarks that generics manufacturers can use to evaluate their own programs and costs. Beyond key benchmarks that drive bioequivalence studies such as studies per ANDA, cost per volunteer, cost per sample, the research study provides a clear picture of organizations' use of outsourcing for bioequivalence (BE) studies. In all, the report identifies:         

  • Key industry metrics for bioequivalence program costs 
  • Geographic trends in bioequivalence testing 
  • Sponsor support activities that drive bioequivalence success 
  • Successful QA structures and strategies in bioequivalence 
  • Trends in use of pilot studies, power and e-submissions  

Go to to review a complimentary summary with samples of metrics such as use of CROs for BE studies in emerging markets, percentage of organizations with quality assurance groups and benefits for use of pilot studies. The study includes insights drawn from primary research involving 20 executives at 18 leading generic pharmaceutical manufacturing companies.


Best Practices, LLC serves 48 of the world's 50 top pharmaceutical companies.  For 17 years, we have conducted work based on the simple yet profound principle that organizations can chart a course to superior economic performance by studying the best business practices, operating tactics and winning strategies of world-class companies.  For more information about the company, go to

SOURCE Best Practices, LLC
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