Pre-clinical provisions of the “Administrative Measures for Drug Registration” (Bureau Order No. 28)
Article 21 Pre-clinical research on drugs for drug registration, including drug synthesis process, extraction method, physical and chemical properties and purity, dosage form selection, prescription screening, preparation process, inspection method, quality index, stability, pharmacology , Toxicology, animal pharmacokinetics, etc. Traditional Chinese medicine preparations also include research on the origin, processing and processing of original medicinal materials; biological products also include the origin, quality standards, storage conditions, biological characteristics, genetic stability and Research in immunology, etc.
Drug preclinical research shall implement the relevant management regulations, of which safety evaluation research must implement the “Non-Clinical Drug Quality Management Standards.”
Main contents of preclinical research on biopharmaceuticals
Main pharmacodynamic experiments
General pharmacological research
Acute toxicity test
Long-term toxicity test
Animal pharmacokinetic test
Heritage toxicity test data
Reproductive toxicity test data
Carcinogenicity test data
Immunotoxicity and/or immunogenicity studies
Hemolytic and local irritation studies
Experiments on the mutual effects of the pharmacodynamics, toxicity and pharmacokinetics of multiple components in the compound preparation
Characteristics of preclinical studies of biopharmaceuticals
Different products are treated differently
Emphasize the quality control of the whole process
Determine content by activity
Biological drugs are usually stored at 2~8℃
Medicilon Pharmacology and Toxicology Service
General pharmacology is an extensive pharmacological study beyond the main pharmacodynamic effects, including secondary pharmacodynamics and safety pharmacology.
1. Nervous system: quantitatively and qualitatively evaluate the animal’s motor function, behavior change, coordination function, sensory/motor reflex and body temperature change after administration.
2. Cardiovascular system: measuring changes in blood pressure, electrocardiogram and heart rate before and after administration
3. Respiratory system: measure the change of respiratory frequency and depth of breath before and after administration
Single dose toxicity test (rodent and non-rodent)
Repeated dose toxicity test (rodent and non-rodent)
Safety pharmacological tests: central nervous system research, cardiovascular system (canine and monkey telemetry and non-telemetry technology), respiratory system
Reproductive toxicity test [Fertility and early embryo development toxicity test (reproduction stage I), embryo-fetal development toxicity test (reproduction stage II)]
Local toxicity test (hemolysis, allergy, irritation test)
Selection of pre-clinical laboratory animals: According to regulatory requirements, guidelines, recommendations and practical experience, choose those that are easy to obtain, easy to raise, easy to operate and manage, and have eating habits that are close to humans or eat half of the food can survive healthy.
Medicilon is a professional preclinical CRO company specializing in pharmaceutical R&D outsourcing services.