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

CHAPEL HILL, N.C. – February 8, 2013. 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

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.

Best Practices, LLC is a leading benchmarking, consulting and advisory services firm serving biopharmaceutical and medical device companies worldwide. Best Practices, LLC’s clients include all the top 10 and 48 of the top 50 global healthcare companies. The firm conducts primary research and consulting using its comprehensive proprietary benchmarking tools and analysis. The operational insights, findings and analysis form the basis for our Benchmarking Reports, databases and advisory services to support executives in commercial and R&D operations. Best Practices, LLC believes in the 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.

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