In June 2019, the laboratory's software and hardware were completed and put into use. The facility is equipped with high-end detection instruments such as LC-MS/MS and microplate readers (with Instrument 3Q Certification), professional software including Watson LIMS (Laboratory Information Management System) and WinNonlin, and possesses an experimental management system that complies with international standards.
In June 2019, the laboratory was fully constructed in terms of software and hardware and put into operation. The facility is equipped with high-end analytical instruments such as LC-MS/MS systems and microplate readers (all instruments qualified with 3Q validation), as well as professional software including the Watson LIMS laboratory information management system and WinNonlin. It has established an experimental management system in line with international standards.
Preclinical & Clinical Pharmacokinetic Evaluation of New Drugs
• Preclinical ADME studies of new drugs
• Clinical pharmacokinetics, mainly for Phase I clinical trials
Preclinical Pharmacology and Efficacy Evaluation of New Drugs
• Disease models and evaluation in non-oncology fields (metabolism, respiratory, cardiovascular & cerebrovascular, urology, immunology, etc.)
• Disease models and evaluation in oncology
Integrated Services for Bioequivalence Study
• Biological sample analysis, BE study design, data processing and statistical analysis, etc.
• Integrated bioequivalence study services through strategic alliances with high-quality clinical research sites and preparation pilot platforms
Pharmacokinetic Evaluation of Macromolecular Drugs
• ELISA-based analysis of monoclonal antibodies and polypeptides
• ADA detection
Improved New Drugs / Prodrugs / Novel Formulations
• Participation in the development of improved new drugs and formulations