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Preclinical Research
Pharmacology & Toxicology Study

Pharmacology & Toxicology Study

We use professional teams with significant practical experience in drug safety evaluation and can promise high-quality data and fast turnaround time to support various drug safety evaluation. Our toxicology research can be carried out according to non-GLP or GLP standards. Our research platform has been selected as a Shanghai R&D Public Service Platform. 

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ServicesServices
Medicilon icon-diamond.pngService
  • 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. ]
Medicilon icon-diamond.pngToxicology 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.webp

    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.webp

    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.webp

    Safety Evaluation of Inhalation drug

    Contains:

    PharmacokineticTissue distribution testAcute Toxicity28-day repeated dose toxicityStimulus testAllergy

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Medicilon icon-diamond.pngAdvantages
  • 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).
    Medicilon features qualities like AAALAC Accreditation and GLP certificate by NMPA, and has passed the on-site inspection by FDA
Service Cases

 Medicilon Assisted Regor Therapeutics Group's New-generation Tumor-targeting Inhibitor RGT-419B Getting Approved for Clinical Use.webp

Medicilon Assisted Regor Therapeutics Group's New-generation Tumor-targeting Inhibitor RGT-419B Getting Approved for Clinical Use

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    Medicilon assisted China's First Original Research Highly Selective EP4 Receptor Antagonist YY001 Obtained Clinical Approval.webp

Medicilon assisted China's First Original Research Highly Selective EP4 Receptor Antagonist YY001 Obtained Clinical Approval

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       [Medicilon Assist]KBMAB-16 for the Treatment of Sarcoidosis has been Approved by the FDA for Clinical Trials.webp

[Medicilon Assist]KBMAB-16 for the Treatment of Sarcoidosis has been Approved by the FDA for Clinical Trials

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For more service cases, please contact us:

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