Frontage Laboratories conducts bioequivalence (BE) studies and bioavailability (BA) studies and provides related medical writing and regulatory support in China.
The demand for BE/BA studies in China from high quality CROs increased significantly after the Chinese FDA took a more robust approach to the enforcement of quality standards and issues with data deficiencies and, in certain cases, required that certain generics that had already been approved be retested and new bioequivalence studies to be conducted. Since January 1, 2015, Frontage has supported over 70 active applications for approval to the Chinese FDA for equivalence recognition.
BE/BA Studies Capabilities and Support:
- Our Clinical Services team is familiar with the applicable regulations and relevant industry standards required and expected by our customers for standard medical documentation, including consent forms, periodic safety reports, protocols and abstracts.
- Perform studies that track and manage adverse effects of drugs that have already received regulatory approval and may have been released onto the market.
- In compliance with Chinese law, our clinical trial services conducted on patients are done in collaboration with 18 hospitals.
- Experience with a number of drugs and variety of indications such as cancer, infectious disease and central nervous system disease.
Our bioequivalence business unit provides support for international customers seeking to make applications for approval in the United States.
- We supported the first ever ANDA filing by a Chinese company for a generic in the United States, and have continued to build on our experience in this area.
- Significantly, we conducted BE studies on eight out of the first ten ANDA projects submitted by Chinese companies to the US FDA.
- One of our hospital centers at Changchun, China, has received approval by the US FDA, the only bioequivalence center in China to do so.