Medicilon's 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.
Animal Facilities
- 50,000 Sq. ft. total area
- 12,500 Sq. ft. for function area
- 12,500 Sq. ft. for Canine housing: maximum capability for 350 canines
- 12,500 Sq. ft. for Nonhuman Primate housing: maximum capability for 400 NHPs
- 12,500 Sq. ft. for Barrier system for Rodent housing: Separate SPF and non-SPF area; maximum capability for 5000 animals of SPF area and 500 animals of non-SPF area
- Design and Operation of the facility are under international and Chinese regulations
Drug Preclinical Safety Evaluations (SFDA, FDA GLP Compliance)
- Single dose toxicity study
- Repeated dose toxicity study
- Safety pharmacology study
- Genotoxicity study
- Reproductive toxicity study
- Immunogenicity study
- Toxicokinetic study
- Topical toxicity study
Drug evaluation research completed from 2008 to 2010
More than 1000 per year preclinical researches have been completed, including single-dose toxicity studies, repeated-dose toxicity studies, topical toxicity studies, toxicokinetic studies and pharmacokinetic studies, now the company has been expanding the safety evaluation to safety pharmacology study, immunogenicity study, genotoxicity and reproductive toxicity study. At present, evaluation and research of several IND packages are being conducted and will be submitted to FDA soon.
Histopathology Capabilities
- Routine and special staining techniques
- Preparation of slides with high quality
- State-of-the-art automated equipment: Slide and cassette printing (Leica) ;Tissue processing (Leica) ; Hematoxylin & eosin staining(Leica)
- Professional microscopic review by domestic and international pathologists
Clinical Pathology Capabilities
- Hematology
- Eukocyte count (total and 5 part differential), Erythrocyte count, Hemoglobin, Hematocrit, Mean corpuscular hemoglobin, Mean corpuscular volume, Mean corpuscular hemoglobin concentration, Absolute and percent reticulocytes, Platelet count, Blood cell morphology
- Urinalysis
- Volume, Specific gravity, pH, Color and appearance, Protein, Glucose, Bilirubin, Ketones, Blood, Urobilinogen, Nitrite, Leukocyte, Microscopy of centrifuged sediment
- Coagulation
- Prothrombin time, Activated partial thromboplastin time, Thrombin time, Fibrinogen
- Clinical Chemistry
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