Drug Safety Evaluation (GLP)
Following ICH, NMPA and FDA guidelines, our PK laboratory can design and conduct in vivo and in vitro PK tests, TK tests and other studies according to customers’ needs; providing customers with a complete set of PK evaluation and optimization services. We provide high-quality data and efficient trial cycles to meet the needs of our customers from early drug discovery to IND application.
Service Contents
◆Single dose toxicity (mice, rats, rabbits, dogs, monkeys, miniature pigs, etc.)
◆Repeated dose toxicity (mice, rats, rabbits, dogs, monkeys, miniature pigs, etc.)
◆Safety pharmacology (core battery test (conscious telemetry (implantable, non-implantable available), locomotor, subthreshold hypnosis, rotarod test, FOB test, anesthetized animals), a variety of follow-up and supplemental safety pharmacology studies)
◆Topical toxicity (including ophthalmic, respiratory, reproductive tract, cutaneous and other local routes of administration)
◆Immunogenicity (including cellular immunity, humoral immunity, ADA, and neutralizing antibodies)
◆Genotoxicity (AMES, mammalian cell chromosome aberration test, micronucleus test, TK test for lymphoma cells)
◆Reproductive toxicity (Segment I, II, III rats, Segment II rabbits)
◆Carcinogenicity test (2-year long-term carcinogenicity test in rats, short- and medium-term carcinogenicity test in transgenic mice, rodent initiation-promotion model, carcinogenicity test in neonatal rodent carcinogenicity model)
◆TK test
◆Specialty drug system: pediatric drugs, ophthalmic drugs, cutaneous drugs, cell and gene therapy drugs
◆Routes of administration: oral, transdermal, intradermal, intranasal, intravaginal, inhalation, subcutaneous, intraperitoneal, intramuscular, intravenous, intra-articular, ocular routes, etc.