“Administrative Measures for Drug Registration” (Bureau Order No. 28) for pre-clinical provisions
Article 21 Pre-clinical research 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 research, 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 research shall implement relevant management regulations, among which safety evaluation research must implement the “Non-clinical Drug Research Quality Management Standards.”
Main content of preclinical research
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
Characteristics of Preclinical Research
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
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.
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)]
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.