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Managing Bioequivalence Studies to Optimize Cost, Quality, and Outsourcing of Generics Manufacturing
Date:2/10/2013

CHAPEL HILL, N.C., Feb. 10, 2013 /PRNewswire/ -- The global generics drug market has grown substantially in previous years and is expected to see even more growth in the coming years. Given the rapid progress of the sector, organizations must critically manage and assess bioequivalence studies that are mandatory when bringing new generic drugs to market.

Development, quality, cost and, speed are all vital success factors in the sector of generics. In order to help generics manufacturers identify effective strategies and processes for managing the bioequivalence component of generics development, benchmarking research firm Best Practices, LLC conducted a wide-ranging and detailed study. The benchmark report delivers key performance and process benchmarks that generics manufacturers can use to evaluate their own programs and costs.

"Pharma Bioequivalence Strategies: Performance Metrics, Processes & Trends" is a new 49-page benchmarking study that aims to identify key cost, quality and productivity metrics for the process of conducting bioequivalence studies. Beyond key benchmarks that drive bioequivalence studies such as cost per volunteer, studies per ANDA, and cost per sample, the research also provides a clear picture of organizations' use of outsourcing for bioequivalence.

The study includes insights drawn from primary research involving 20 executives at 18 leading generic pharmaceutical manufacturing companies. Other key topics the study identifies include:

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

SOURCE Best Practices, LLC
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