跳至主要内容

Toxicology Services


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

评论

此博客中的热门博文

What is preclinical testing?

In the process of  preclinical testing  of a compound or biological agent into a drug, the compound involved must go through the testing phase. First, we need to identify potential targets that can treat the disease. Then, a variety of compounds or preparations are screened out. Any compound that has shown potential as a drug for the treatment of this disease needs to be tested for toxicity before clinical testing to reduce the possibility of injury. preclinical testing What is the basis of preclinical testing? According to US Food and Drug Administration (FDA) regulations, a series of tests are required before a new drug is approved for use. In the first stage, basic research determines a hypothetical target for the treatment of a certain disease, and then screens small molecules or biological compounds to discover any substance with the potential to treat the disease. Then, a  preclinical research  phase followed, before which, as described above, the potential toxicity of the compou

Inventory of the three major in vitro pharmacokinetic research methods

  The metabolic properties of a compound are an essential factor in whether or not it can be used as a drug in the clinical setting, so pharmacokinetic studies of newly synthesized compounds are required in drug development. In vitro incubation with liver microsomes, recombinant CYP450 enzyme lines, and in vitro incubation with hepatocytes are some of the more common in vitro drug metabolism methods. 1. In vitro incubation method with liver microsomes The metabolic stability and metabolic phenotypes of candidate compounds in different species of liver microsomes are good predictors of the metabolic properties of compounds in vivo. They are practical tools for evaluating candidate compounds in the pre-development phase of drug development. Liver microsomes include rat liver microsomes, human liver microsomes, canine liver microsomes, monkey liver microsomes, and mouse liver microsomes. In in vitro incubation of the liver, microsomes are the "gold standard" for in vitro d

Novel Parkinson’s Therapies Possible with New Mouse Model

Parkinson's disease (PD) is a neurodegenerative disorder that is marked by the accumulation of the protein, α-synuclein (αS), into clumps known as Lewy bodies, which diminish neural health. Now, researchers from Brigham and Women's Hospital (BWH) report the development of a mouse model to induce PD-like αS aggregation, leading to resting tremor and abnormal movement control. The mouse responds to L-DOPA, similarly to patients with PD. The team's study (“Abrogating Native α-Synuclein Tetramers in Mice Causes a L-DOPA-Responsive Motor Syndrome Closely Resembling Parkinson’s Disease”) on the use of this transgenic mouse model appears in  Neuron . “α-Synuclein (αS) regulates vesicle exocytosis but forms insoluble deposits in PD. Developing disease-modifying therapies requires animal models that reproduce cardinal features of PD. We recently described a previously unrecognized physiological form of αS, α-helical tetramers, and showed that familial PD-causing missense mutati