Biological Equivalence Study (BE Study)
Early testing response at pilot scale! We conduct tests flexibly even in the initial development stage.
Our company conducts BE and PK tests overseas as part of our support for the research and development of generic pharmaceuticals. Under a quality management system based on PMDA guidelines, we provide services that meet the needs of Japanese pharmaceutical companies. The ability to conduct pilot BE/PK tests overseas in a short timeframe and at low cost is a significant advantage, especially for Japanese generic pharmaceutical companies. 【Features】 ■ Responding to the trend of acceptance of overseas test data by PMDA - Appropriate test design is possible based on advanced PMDA materials/policies. ■ Early test response at pilot scale: Flexible testing even in the initial development stage. ■ Competitive pricing compared to Japanese CROs. ■ High-quality data and quick turnaround. - Accelerates decision-making for the next steps without slowing down development speed. ■ Extensive track record of support for Japanese companies: Detailed responses tailored to needs. *For more details, please download the PDF (English version) or feel free to contact us.
- Company:リブラメディシーナ
- Price:Other