Department of clinical pharmacology offers a one-stop clinical research service platform that spans phase I clinical trials, bioanalysis, and model-based new drug clinical evaluation.

The Phase I ward is fully equipped, featuring five research wards with a total of 28 research beds. Additionally, it includes a subject reception room, a trial medication storage room, a multipurpose activity room, a sample processing room, a biological sample storage room, doctor and nurse duty rooms, a documentation room, and other reasonably divided areas. In total, 34 phase I clinical trial projects, including 9 therapeutic biological products and 14 new drugs, has been completed since 2021.

   Bioanalytical Laboratory is equipped with an analytical technology platform that meets ISO 17025 standards. It is equipped with one AB Sciex 5500 triple quadrupole LC-MS/MS and one AB Sciex QTRAP 6500+. The laboratory obtained ISO 17025 accreditation from the China National Accreditation Service for Conformity Assessment (CNAS) in August 2013. It can develop bioanalytical methods that meet scientific research, clinical, and drug registration standards according to specific requirements, for analyzing drug concentrations in humans and animals in various scenarios.

  Additionally, the laboratory is dedicated to integrating clinical pharmacology and quantitative pharmacology research throughout the entire process of new drug clinical trials. We aim to establish a development and simulation platform based on model predictions. Currently, we are equipped with physiological pharmacokinetic software, GastroPlus, and population pharmacokinetic software, Phoenix NLME. These tools enable the establishment of physiological pharmacokinetic models, population pharmacokinetic models, and more for comprehensive quantitative pharmacological research. Our goal is to utilize these model-fitting tools to minimize the time and cost of drug development, thereby enhancing the probability and efficiency of success rate of new drug development.