Pharmacology & Toxicology Study

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Service

• Single dose toxicity tests (rodent and non-rodent)Repeated dose toxicity tests (rodent and non-rodent)Genetic toxicity testsImmunogenicity testsToxicokinetic testsLocal toxicity tests (hemolysis, allergy and irritation tests)Carcinogenicity studiesToxicological tests of new drug administration technology: Inhalation toxicologyADC safety evaluationSafety pharmacological tests: central nervous system research, cardiovascular system (telemetry and non-telemetry technology for dogs and monkeys), respiratory system and hERG.Reproductive toxicity tests [fertility and early embryo development toxicity tests (reproductive phase I), embryo-fetal development toxicity tests (reproductive phase II), perinatal toxicity tests (reproductive phase III), or a combination test of each phase. ]

Toxicology research service platforms

• In addition to common administration routes such as PO and IV, the following characteristic evaluation platforms are also established:
  The inhalation administration platformOphthalmic administration platformThe skin administration platformSublingual administration platformThe young animal evaluation platformThe integrated evaluation technology platform for biological innovative drugs such as antibody, vaccine, ADC and CAR-T cell
  Feature Platform:
  

  Safety Assessment of ADC

  Contains:

  Single dose/Repeat dose toxicity (With TK);Tissue cross-reactivity;ADA test.

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  Safety Assessment of Cell & Gene Therapy Drugs

  Contains:

  Single Dose Toxicity TestingRepeated Dose Toxicity TestImmunogenicity / ImmunotoxicityIn vitro Soft Agar Clone Growth TestIn vivo Tumorigenicity / TumorigenicityFormulation SafetyOther: Express Product Safety

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  Safety Evaluation of Inhalation drug

  Contains:

  PharmacokineticTissue distribution testAcute Toxicity28-day repeated dose toxicityStimulus testAllergy

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Advantages

• With a preclinical research institution in line with international standards established earlier in China, Medicilon is proud to be a senior organization with GLP-based laboratories;Medicilon has cooperated with MPI and followed MPI's quality management system/SOP;Medicilon features comprehensive quality control measures three-level QC management mode; Medicilon has a comprehensive data management software system;Based on international standards, Medicilon has developed and established Provantis GLP Tox, EMPOWER data acquisition and management system, Chromeleon chromatographic data system and LIMS system to strengthen the standardization and traceability of the research process;With Submit software and own port, Medicilon can independently complete toxicological research data in SEND format for filing items to FDA. Medicilon features qualities like AAALAC Accreditation and GLP certificate by NMPA, and has passed the on-site inspection by FDA;Medicilon has successfully completed a number of projects, showing its rich experience in meeting clients’ requirements. With rich experience in filing, Medicilon has successfully complete over 100 filing projects based on IND, with contents involving micromolecule drugs and bio-tech-based drugs (including ADC, antibodies, proteins and polypeptides).
  

Service Cases

Learn more about "Pharmacology & Toxicology Study"

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  [Video]How do we determine the low dose in reproductive toxicity tests

  

  [Article]Medicilon's newly added facilities have obtained the GLP certification of NMPA

  

  [video]Safety Evaluation of Medicilon

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