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 percent) 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 percent 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
Click here to access the full report.