Xishan Zhongke has a professional, stable, and experienced toxicology research technical team that can carry out a full range of preclinical safety evaluations, provide high-quality data and a rapid turnaround period to support various drug safety evaluation studies, and can quickly , timely and good communication feedback; can implement drug preclinical safety evaluation research that meets NMPA, FDA, ICH and other regulations and technical requirements, and complies with GLP specifications. Since its establishment, it has completed more than 1,000 safety evaluation services for more than 200 customers. The company fully uses Pristima data management system software to manage test data to ensure the authenticity, standardization and traceability of the data. Equipped with a professional SEND format conversion team, it can independently complete toxicological research data in SEND format for FDA application projects. Currently, it has completed SEND data conversion for more than 20 projects, of which 4 new drug projects have obtained clinical approval from the US FDA.

Comprehensive toxicology studies can be conducted, including:

  • Dose finding trial
  • Single and repeated toxicology (rodent and non-rodent)
  • Safety pharmacological tests: cardiovascular system (emak telemetry system), central nervous system (functional combination observation FOB), respiratory system (emak whole body tracing system)
  • Local toxicity test (hemolysis, irritation, allergy test)
  • Reproductive toxicity test (section Ⅰ, Ⅱ, Ⅲ)
  • Genotoxicity test (Ames, micronucleus, chromosomal aberration, mouse lymphoma test)
  • Carcinogenicity test
  • Immunogenicity test
  • Toxicokinetic test

Special service evaluation

  • Evaluation of ADCs, antibodies, vaccines and other biological products
  • Pediatric Medication Evaluation
  • Evaluation of inhalation preparations
  • Animal species include: dogs, monkeys, mini pigs, rabbits, guinea pigs, large mice, etc.

animal species

  • Animal species include: dogs, monkeys, mini pigs, rabbits, guinea pigs, large mice, etc.

Routes of administration include

  • Oral administration
  • Transdermal administration
  • Intravenous administration
  • Intramuscular injection administration
  • Administration by subcutaneous injection
  • Intraperitoneal injection
  • Intra-articular injection
  • Nasal administration
  • Vaginal administration
  • Rectal administration
  • Intracranial administration
  • Inhalation administration
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