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New Drug Preclinical Trials

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“Administrative Measures for Drug Registration” (Bureau Order No. 28) for pre-clinical provisions
Article 21 Pre-clinical trial of drugs for the purpose of applying for drug registration, including drug synthesis technology, extraction methods, physical and chemical properties and purity, dosage form selection, prescription screening, preparation technology, inspection methods, quality indicators, stability, pharmacology , Toxicology, Animal pharmacokinetics trial, etc. Traditional Chinese medicine preparations also include research on the source, processing and processing of raw medicinal materials; biological products also include the source of starting raw materials, quality standards, storage conditions, biological characteristics, genetic stability and Immunology research, etc.
Article 22: Pre-clinical drug trials shall implement relevant management regulations, among which safety evaluation research must implement the “Non-clinical Drug trials Quality Management Standards.”

Preclinical Studies

Main content of preclinical trial

Main pharmacodynamic experiment
    General pharmacological research
    Acute toxicity test
    Long-term toxicity test
    Animal pharmacokinetic test
    Heritage toxicity test data
    Reproductive toxicity test data
    Carcinogenic test data
    Immunotoxicity and/or immunogenicity studies
    Hemolytic and local irritation studies
    Experiment on the mutual influence of multiple components in compound preparations on efficacy, toxicity and pharmacokinetics
    Dependency experiment

New Drug Preclinical Trials

Characteristics of Preclinical Trial

  • Different products are treated differently

  • Emphasize the quality control of the whole process

  • Determine the content by activity

  • Biological drugs are usually stored at 2~8℃

Medicilon Pharmacology and Toxicology Service

Pharmacology Research

General pharmacology is extensive pharmacological research beyond the main pharmacodynamic effects, including secondary pharmacodynamics and safety pharmacology.
    1. Nervous system: quantitatively and qualitatively evaluate the motor function, behavior change, coordination function, sensory/motor reflex and body temperature changes of animals after administration.
    2. Cardiovascular system: measure changes in blood pressure, electrocardiogram and heart rate before and after administration
    3. Respiratory system: Measure changes in respiratory frequency and respiratory depth before and after administration.

Toxicology Research

  • Single dose toxicity test (rodent and non-rodent)

  • Repeated administration toxicity test (rodent and non-rodent)

  • Safety pharmacology test: central nervous system research, cardiovascular system (telemetry and non-telemetry technology for dogs and monkeys), respiratory system

  • Genetic toxicity test

  • Reproductive toxicity test [fertility and early embryo development toxicity test (reproductive stage I), embryo-fetal development toxicity test (reproductive stage II)]

  • Immunogenicity test

  • Toxicokinetics

  • Local toxicity test (hemolysis, allergy, irritation test)

Pre-clinical laboratory animal selection: According to regulatory requirements, guiding principles and recommendations, and practical experience, choose easy-to-obtain, easy-to-feed, easy-to-operate and manage, eating habits close to humans or eating half of the food can survive healthy.

Shanghai Medicilon is a professional pre-clinical CRO company specializing in outsourcing services for pharmaceutical R&D.

Phone: 86-021-58591500


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