The technical service capabilities include non-clinical safety evaluation of drugs, pesticides, health food, medical devices and chemicals. We conduct tests on single and repeated dose toxicity, genotoxicity, reproductive toxicity, local tolerance, immunotoxicity, safety pharmacology, carcinogenicity, and toxicokinetics under GLP conditions. In addition, we have rich experience in clinical biological sample analysis, pharmacodynamics research of anti-tumor drugs, early-stage toxicity screening of candidate drugs, mechanism of drug toxicity, and new technology and new method establishment.
NDSEC & UG is the key laboratory of the NMPA for “Innovative Drug Safety Research and Evaluation”, the public technology service platform for “Drug Safety and Druggability Evaluation” of Beijing Economic and Technological Development Zone; “Beijing Engineering Laboratory for Key Technologies of Drug Safety Evaluation” of Beijing Municipal Commission of Development and Reform; High-tech enterprise in Beijing and Zhongguancun etc.
NDSEC & UG has undertaken a number of national, provincial and ministerial-level projects such as the National Major Project of Science and Technology for the “Major New Drug Creation” in the 11th, 12th, and 13th Five-Year Plan.
NDSEC & UG holds several accreditations, includes NMPA good laboratory practice (GLP), CNAS GLP, CMA, Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC). Several safety assessment projects have been successfully used to support FDA's new drug registration application.
2. Characteristic Technology Platforms
2.1 Druggability evaluation platform: Several rapid toxicity screening models in the early stage of new drug have been established, including genotoxicity screening model based on mini-Ames method, in vitro hepatotoxicity screening model based on HepG2 and primary hepatocytes, target organ toxicity screening models based on zebrafish embryos. In addition, we can also evaluate the drug metabolism difference based on liver microsomal enzymes from different species and the bioavailability based on rapid PK model.
2.2 Biological sample analysis platform: The platform dedicated to the evaluation of generic drug consistency, human bioequivalence, non-clinical and clinical PK/PD, non-clinical toxicokinetic, metabolomics, and other technical services.
2.3 Reproductive toxicity evaluation platform: We have excellent expert resources, rich experience, and systematic background data in reproductive toxicity evaluation. According to the domestic and international technical guidelines, we can carry out the fertility and early embryo toxicity test (phase I), rats or rabbits embryo-fetus development toxicity test (phase II), perinatal toxicity test (phase III), one-generation reproductive toxicity test, reproductive toxicity screening test, and so on.
2.4 Inhalation preparations safety evaluation platform: We have been conducting inhalation toxicology research for more than ten years. The completed evaluation items for inhalation preparation including acute inhalation toxicity test, 7-day, 14-day, 28-day, 90-day repeated inhalation toxicity test, respiratory system tissue distribution test, respiratory tract irritation test, allergic test, and respiratory tract cilia toxicity test.
2.5 Pediatric medications safety evaluation platform: We can carry out non-clinical safety evaluation of neonatal and weaned rats, neonatal miniature pigs, juvenile dogs and young monkeys. We have accumulated rich experiences in juvenile animal feeding and health management, physical restraint, drug administration, blood collection and other aspects.
2.6 Photosensitizer safety evaluation platform: We can carry out a complete set of tests on the efficacy, pharmacokinetics, routine toxicology and phototoxicity of photosensitizers. We have established a variety of phototoxicity and photosensitivity evaluation techniques for non-photosensitizers.
We are willing to cooperate with new drug research and development companies or institutions to promote the advancement of new drug research and development.
General Manager: Jinfeng Wei
Tel: 010-67817727, 13911088607
E-mail: weijinfeng@www.myhortonhome.com
