Bioavailability and bioequivalence studies
We provide one-stop services for drug bioavailability and bioequivalence studies: Subject selection, clinical trials, SMO services, biological sample testing, data management and statistical analysis.
We can undertake all stages of the clinical study including clinical research center construction, clinical audit, sample management, research program design, management and summary reports. Establish the Phase I Clinical Research Center with eight hospitals, including Hunan Prevention and Treatment Center for Occupational Diseases (湖南省职业病防治院), Brain Hospital of Hunan Province (湖南省脑科医院), Hunan Provincial Maternal and Child Health Care Hospital (湖南省妇幼保健院), Changsha Central Hospital (长沙市中心医院), The Second Nanning People’s Hospital (南宁市第二人民医院), The Second People’s Hospital of Neijiang, Sichuan (四川省内江市第二人民医院), The First Affiliated Hospital of Chengdu Medical College (成都医学院第一附属医院), and Kangya Hospital of Yiyang, Hunan (湖南益阳康雅医院); establish strategic partnerships with more than 20 hospitals including Xiangya Hospital (湘雅医院), The Second Xiangya Hospital (湘雅二院), Hunan Cancer Hospital (湖南省肿瘤医院), and Mengchao Hepatobiliary Hospital of Fujian Medical University (福建医科大学孟超肝胆医院).
Clinical research: According to the GCP and ICH standards, as of July 2018, more than 50 drug bioavailability and bioequivalence (BA/BE) research projects have been completed, and all applications for registration have successfully passed the official on-site inspection.
Bioanalysis: Break the foreign monopoly and adopt the Self-Development Laboratory Information Management System (LIMS); It has established the world’s unique DMPK joint laboratory with Waters in the United States, which is one of Waters’ three joint laboratories in China (Chinese Pharmacopoeia Commission, Duxact and Tsinghua University); since “7.22 CFDA reforms,” the PK/BE study of more than 100 registered drugs has been completed and all ISR values are greater than 99% (industry standard >67%).
Statistical analysis: Provide clinical data management, PK parameter calculation and biostatistics analysis services for more than 30 well-known enterprises at home and abroad according to international standards. The official on-site inspection passing rate is 100%.