The preclinical services that Medicilon offers focus on preclinical pharmacokinetic and safety evaluation for foreign and domestic clients.
Our toxicology department has professional teams with rich experience in toxicology studies. We offer high-quality data and rapid turnaround period to support drug discovery and development. Our toxicological studies are conducted in various animal species. The toxicological evaluation from dose design, in-life studies to histology and pathology testing along with toxicokinetics studies are all compliant with GLP or NON-GLP standards. Our study platform is certified as one of the Shanghai Public Service Research Platforms.
- Single Dose Toxicity Test (rodent and non-rodent)
- Repeated Dose Toxicity Study (rodent and non-rodent)
- Safety Pharmacology Test: telemetry and non-telemetry to monitor the electrocardiogram and respiration of dogs and monkeys, rats FOB
- Genotoxicity Tests
- Reproductive Toxicity Test
- Immunogenicity Test
- Toxicokinetic
- Partial Toxicity Test
Joint Operation
A Joint Venture, Medicilon Preclinical Research (MPR), was established and managed from 2008 and 2010 by Medicilon and MPI Research. (A US based CRO specialized in non-clinical drug safety evaluation) During the joint operation, MPI Research introduced US GLP system and SOPs of MPI Research to MPR. The scientists from MPI Research trained the employees of MPR intensively and extensively and completed many non-clinical drug evaluation studies sponsored by both foreign and domestic clients with the scientists and technicians from Medicilon.
GLP Qualification
MPR has been accredited by CFDA as GLP laboratory in 2011 and re-accredited by CFDA in 2014. The toxicity study data is also for US FDA and OECD GLP standards.
AAALAC
MPR has been fully accredited by AAALAC in 2009 and re-accredited by AAALAC in 2012.
The Animal Facilities
- Rodent: 13,000
- Rabbit: 400
- Guinea Pig: 400
- Monkey: 500
- Dog: 700
Platform
- The technical service platform of evaluation of biotech drug safety on non-human primate
- The technical service platform of experiment on non-human primate
- The technical service platform of drug discovery and screening based on protein crystallography
- The technical service platform of evaluation of isotope labeling drug metabolism
The Projects
More than 30 packages of non-clinical drug safety evaluation and about 800 single toxicity studies have been completed since 2012. The test articles include small molecular drugs, biotech drugs, vaccine (monovalent and multivalent ) and traditional Chinese medicine and natural drugs.
New Drug Application
Since 2012, 15 non-clinical safety evaluation packages and more than 60 single toxicity study data generated from MPR were used by the clients in IND application to CFDA, US FDA and Australia TGA separately.
Software
Provantis is used for data collection, processing and storage of drug safety evaluation studies; while Siemens is used for monitoring the animal room environment.
