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SAFE Service
Preclinical Safety Assessment
Preclinical safety assessment
As a CRO with rich project experiences, SAFE pharmaceutical is capable of adopting international technical standards and standardized quality management system to provide the most comprehensive preclinical safety evaluation programs that meet the requirements of NMPA in China, FDA in the United States, OECD and other national laws and regulations. More than half of SAFE's technical staff have master's degree. Meanwhile, more than half the staff got 10 or more years' experience in national GLP centers.
Service
• Single dose toxicity
Rodent animals and non-rodent animals (including non-human primates)
• Repeated dose toxicity
Rodent animals and non-rodent animals (including non-human primates)
• Genetic toxicity
Ames test, Chromosomal aberration test, Micronucleus test, Mouse lymphoma TK site test
• Carcinogenesis
• Immunogenicity test
• Immuno toxicity
• Drug dependence
• Reproductive toxicity (DART)
General reproductive toxicity test (paragraph I), Teratogenic sensitive period toxicity test (paragraph II), Perinatal toxicity test (paragraph III)
• Safety pharmacology
• Toxicokinetics
• Local toxicity
irritation test, allergy test, hemolysis test, phototoxicity test, etc.
Advantages
• Evaluation of cell products (stem cells, CAR-T, TCR-T, CTL, etc.)
• Dependency test, physical dependence, mental dependence
• Neuropsychiatric evaluation
• Pediatric drug safety evaluation
• Inhalation formulation safety evaluation
• Senior toxicologists and consultants
• Document writing service
Animal species
• Rodents (mouse, rat, guinea pig, hamster)
• Rabbit
• Mini pig
• Beagle dogs
• Non-human primates (cynomolgus monkey, rhesus monkey)
• Multiple disease model animals
Route of administration
• Oral administration
• Intravenous administration (bolus, infusion, continuous administration)
• Intramuscular injection
• Skin administration (skin, subcutaneous, intradermal)
• Nasal administration
• Joint cavity administration
• Arachnoid administration
• intracranial administration
• Inhalation administration
• Transrectal administration
• Transvaginal administration
• Surgical implantation
• Oral spray administration

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