Featured Stories

The safety evaluation is the main sector, and the certification qualification and the area of ​​the laboratory are hard indicators Pre-clinical research services include safety evaluation research, pharmacokinetics, pharmacology and toxicology, animal models, etc. This stage is mainly to conduct laboratory research and live animal research on lead compounds under laboratory conditions to observe theirRead more

The content of toxicokinetic studies in different toxicity tests, such as the frequency of exposure monitoring and characterization, can be increased or decreased according to research needs. The toxicokinetic studies of different toxicity tests are considered as follows: (1) Single-dose toxicity test The toxicokinetic results of a single-dose toxicity test are helpful for evaluating andRead more

In order to promote and standardize the research and development of radioactive in vivo diagnostic drugs in my country, on February 24, under the deployment of the National Medical Products Administration, the Center for Drug Evaluation organized the formulation of the “Technical Guidelines for Non-clinical Research of Radioactive In vivo Diagnostic Drugs”, which was approvedRead more

01Technical requirements for phase I clinical trial application 1Researcher’s Handbook The Investigator’s Handbook is a summary of the pharmacy, non-clinical and clinical research (if any) data available when the trial drug is being studied in the human body. It aims to provide clinical investigators with information on the research drug to ensure the safety ofRead more

(1. Center for Drug Evaluation of the State Food and Drug Administration, Beijing 100038; 2. Laboratory of Pharmacology and Toxicology, Shanghai Family Planning Research Institute, China Fertility Regulation Drug Toxicology Testing Center, Shanghai 200032; 3. National Population and Planning Key Laboratory of Family Planning Medicines of the Fertility Committee, Shanghai 200032; 4. Institute of ReproductionRead more