Generic pharmaceutical manufacturing companies are expected to increase outsourcing for bioequivalence studies to less regulated countries in the near future. However, selecting a contact research organization (CRO) that is cost efficient and at the same time provides quality results is often challenging. In addition, companies have to make sure that CROs are adhering to protocols and correct guidelines when conducting bioequivalence studies.
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.