Study Details Best Practices in Managing Pharmaceutical Bioequivalence Studies

CHAPEL HILL, N.C., March 25, 2016 /PRNewswire/ -- As the global generics drug market continues to grow substantially, organizations must critically manage and assess bioequivalence studies that are mandatory when bringing new generic drugs to market. One key area that leaders are assessing is whether or not outsourcing is necessary or will help to ensure success.

According to research from benchmarking firm, Best Practices, LLC, a majority of benchmarked companies (56%) outsource fewer than one-quarter of their bioequivalence studies to CROs in less-regulated areas, such as India, China, Russia and Eastern Europe. India gets the lion's share of the outsourcing, with 78% of the Generic companies using CROs there.

The related report, "Pharma Bioequivalence Strategies: Performance Metrics, Processes & Trends," will provide leaders with comparative costs, quality, productivity metrics and best practices that can be used in evaluating the performance of their bioequivalence testing programs.

The study includes insights drawn from primary research involving twenty 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  

To access the full report, or to download a complimentary summary containing insights found in this report, click on the following link: http://www.best-in-class.com/rr1421.htm

For more information on other recent primary research studies, contact us at 919.403.0251. For related research, visit our Best Practices, LLC website at http://www.best-in-class.com/

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.

SOURCE Best Practices, LLC

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