Drug Safety Evaluation

Pharmacology & Toxicology Study

We boast professional teams and practical experience in drug safety evaluation and can promise high-quality data and fast turnaround time to support various drug safety evaluation. Our toxicology research can be carried out according to non-GLP or GLP standards. Our research platform has been rated as Shanghai R&D Public Service Platform.

https://www.medicilon.com/services/drug-safety-evaluation/

Safety Pharmacology

We can provide safe pharmacological experiment services using large and small animals to explore the effects of drugs on central nervous system, respiratory system and cardiovascular system, and to support drug R&D.

Histopathological Study

In diagnosis, histopathological diagnosis is considered as the gold standard to determine diseases and their natures. Before the body shows obvious clinical symptoms, the influence of drugs on the body tissues and organs can be found through histopathological examination, so as to provide reference for the prevention and treatment of diseases. In drug filing, all relevant institutions pay great attention to the results of histopathological diagnosis because such results can provide important basis for judging the potential harm degree of the drugs to be filed.

The guidelines issued by various regulatory agencies also require histopathological diagnosis results of short-term toxicity, subchronic toxicity, chronic toxicity and carcinogenicity tests. As a comprehensive CRO enterprise, Medicilon provides considerate services in histopathology.

Clinicopathological Study

Our Clinicopathology Laboratory is a GLP-based medical laboratory affiliated to the Pathology Research Department. The laboratory is mainly responsible for various items including animal biochemistry, hematology, coagulation, urine analysis, microscopic examination of urine sediment, lymphocyte typing, in vitro hemolysis, microscopic examination of marrow smear and animal physical examination, aiming to provide accurate and scientific inspection basis for animal experiments. The laboratory has participated in the room quality assessment by Shanghai Center for Clinical Laboratory and been awarded certificates for three consecutive years with every item qualified.

Drug Safety Evaluation Basic Information

We boast professional teams and practical experience in drug safety evaluation and can promise high-quality data and fast turnaround time to support various drug safety evaluation. Our toxicology research is carried out using different animals, from dose design, experimental research to histological and pathological research (including clinical detection). The research can be carried out according to non-GLP or GLP standards. Our research platform has been rated as Shanghai R&D Public Service Platform.

Toxicokinetics

We boast complete pharmacokinetic, toxicokinetic and analytical research facilities and instruments. Our Toxicology Research Department has been granted AAALAC Accreditation and GLP certificate of NMPA and passed the on-site evaluation, with research globally-recognized capabilities to support filing programs for multiple countries.

https://www.medicilon.com/services/drug-safety-evaluation/