Sop Phase I

Laboratory for Phase I Clinical Trials

The laboratory for Phase I clinical trials were certified in June 2005 to perform drug tolerance, pharmacokinetics, and bioequivalence studies. The lab has 13 employees, including 1 physician, 2 study nurses, and 10 pharmacists. Over 80% of the employees have Master’s or PhD degree. The 300 square-meter center hosts 24 beds for Phase I studies and clinical monitoring. Various functional rooms and facilities are in place to ensure patient safety. The analytical lab has the following equipments for fast and accurate bioanalysis to ensure validity and traceability of clinical data:
LC-MS (API 4000 and API 3200) x2
Ultra Performance Liquid Chromatography x1
High Performance Liquid Chromatography x1
Solid Phase Extraction System x1
Pressure Blowing Concentrators x1
-80℃ freezers x2
-20℃ freezers x2
Refrigerators x5
Low Temperature High Speed Centrifuges x2
Vortexes x4
Ultrapure water system x1
Lab Environment Monitoring Systems x3