Drug Safety Evaluation Basic Information

Medicilon has experienced teams who are experts in drug safety evaluation and can promise high-quality data and fast turnaround times 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.

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Sino-foreign joint venture

In 2008, Shanghai Medicilon Inc. and MPI Research (an American CRO specializing in non-clinical drug safety evaluation services) established a joint venture - Medicilon Preclinical Research. As part of the joint venture, MPI provided the American GLP system and standard operation procedures for research to Medicilon Preclinical Research. Scientists from MPI provided training sessions for Medicilon Preclinical Research employees, and completed many non-clinical drug evaluation research projects with Medicilon scientists and technicians for clients at home and abroad.

As GLP-based laboratories are important for non-clinical drug researches, Medicilon Preclinical Research became one of the early CRO companies that built preclinical animal laboratories in China after following their American peers’ experience. The joint venture has been granted AAALAC Accreditation and GLP certification by NMPA, and meets the FDA’s GLP standards . Medicilon Preclinical Research is qualified for IND services and has been granted AAALAC Accreditation.

GLP certificate

NMPA granted Medicilon Preclinical Research GLP certification in 2011. Its toxicological research data also meets GLP standards of both the FDA and the OECD.

AAALAC

In 2009, the Medicilon’s preclinical research experiment facilities were granted AAALAC Accreditation, and then again in both 2012 and 2016.

Animal rooms

Medicilon Preclinical Research has rooms for the following animals:
Mice/rats: 13,000Rabbits: 400Guinea pigs: 400Non-human primates: 550Dogs: 700Miniature pigs: 100

Platform construction

Technical Service Platform for Non-human Primate Bio-tech-based Drug Safety Evaluation in ShanghaiTechnical service platform for non-human primate experiment researchDrug discovery and screening platform based on protein crystallographyTechnical service platform for isotope drug metabolism research

Completed projects

Since 2012, Medicilon Preclinical Research has completed over 30 outsourcing services for non-clinical drug safety evaluation and 800 toxicological services. The tests involve micromolecule drugs, bio-tech-based drugs, vaccines (monovalent and multivalent), Chinese medicines, and natural medicines.

Filing of new drugs

Since 2012, Medicilon Preclinical Research has completed nearly 50 complete sets of application materials for GLP toxicology packages, as well as hundreds of individual toxicological studies for non-clinical safety evaluation outsourcing services. The data has been reported to the NMPA, FDA, and TGA to support IND filing.

Relevant laboratories

Relevant articles

Safety Pharmacology Histopathological Study Clinicopathological Study Drug Safety Evaluation Basic Information Toxicokinetics