If this box remains here for more than 30 seconds, click this link to try again.
Products & Services »
Download FREE Excerpt
26 Data Graphics
4 Best Practices
Single User: Authorizes use by the person who places the order or for whom the order was placed.
Sitewide: Authorizes use of the report for a geographic site. All people at site can view the report for a year and copies can be printed.
Corporate: Authorizes use for the entire company for a year and copies can be printed. No limitations for usage inside the company.
Best Practices, LLC conducted this timely benchmarking research that identifies key cost, quality and productivity metrics for the process of conducting bioequivalence studies required to bring a new generic drug to market. Specifically, this study looks at the growing trend in outsourcing for bioequivalence studies. In addition, the study also includes executive insights, lessons learned and best practices for productivity in the bioequivalence study process. Generic companies can use the comparative metrics in this study to evaluate their current bioequivalence testing programs.
Twenty executives at 18 leading generic pharmaceutical manufacturing companies participated in this benchmarking study. Most benchmark participants hold job titles at the director-level and above, and nearly half work in R&D organizations. The greatest number—42%—are located in the US, with another 37% in India. Qualitative and quantitative data for this study were collected through an online survey instrument.
Sample Key Findings
Use of Less Regulated Regions: A majority of participating companies (56%) outsource fewer than one-quarter of their bioequivalence studies to CROs in less-regulated regions, such as India, China, Russia and Eastern Europe.