Managing Bioequivalence Studies to Optimize the Quality, Cost, and Speed of Generics Manufacturing
CHAPEL HILL, N.C. – August 25, 2011. 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 http://www.best-in-class.com/rr1109.htm 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.
ABOUT BEST PRACTICES, LLC
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.