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Safety pharmacological test/animal pharmacological test

2017-06-26
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Safety pharmacology is mainly to observe the adverse effects of the drug on the central nervous system, cardiovascular system and respiratory system when the drug is in the treatment range or above the treatment range. Additional and/or supplementary safety pharmacology studies that may be carried out as needed should also include observations of the urinary system, autonomic nervous system, digestive system and other organs and tissues. The purpose and significance of safety pharmacology research is to discover undesirable pharmacological effects that may be related to clinical safety, evaluate adverse reactions or pathological effects observed in toxicological tests or clinical studies, and explore the mechanism of adverse reactions.

Test type Animal species Type of drug Route of administration Research content
Safe pharmacology Mouse
Rat
Guinea pig
Rabbit
Beagles
Small molecule
biological
Natural products
vaccine
traditional Chinese medicine
Oral: gavage, capsule
Parenteral: intraperitoneal injection, intravenous injection, intramuscular injection, intradermal injection, subcutaneous injection, continuous infusion, intravitreal injection
Other: nasal feeding, nasal cavity, eyes, rectum, vagina, implant
Cardiovascular system (anaesthetized animals/awake animals)
Central nervous system: spontaneous activity test in mice, runner test in mice, prolonged sleep time test of pentobarbital sodium in mice, subthreshold hypnotic dose test in mice
Cardiovascular system: blood pressure, electrocardiogram, heart rate, etc. before and after administration
Respiratory system: respiration rate and depth of respiration before and after administration
Supplementary test

Safety Pharmacology is mainly to study the potential undesirable adverse effects on physiological functions when drugs are within the therapeutic range or above the therapeutic range, that is, to observe the effects of drugs on the central nervous system, cardiovascular system and respiratory system. influences. Carry out additional and/or supplementary safety pharmacology studies as needed.
Additional safety pharmacology studies (Follow-up Safety Pharmacology Studies): According to the pharmacological action and chemical structure of the drug, possible adverse reactions are expected. If there are doubts about the results of existing animal and/or clinical trials that may affect human safety, additional safety pharmacology studies should be conducted, that is, in-depth studies on the central nervous system, cardiovascular system, and respiratory system.
Supplemental Safety Pharmacology Studies: To evaluate the effects of drugs on the functions of organs other than the central nervous system, cardiovascular system and respiratory system, including the urinary system, autonomic nervous system, gastrointestinal system and other organs and tissues Research.
The research objectives of safety pharmacology include the following aspects: determine the undesired pharmacological effects of drugs that may be related to human safety; evaluate the adverse drug reactions and/or pathophysiological effects of drugs observed in toxicological and/or clinical studies ; The mechanism of adverse drug reactions observed and/or speculated in the research.

The basic principle

(1) Test method

The trial design should be rationally based on the characteristics of the drug and the purpose of clinical use. Choose appropriate and validated methods, including scientific and effective new technologies and new methods. Certain safety pharmacology studies can select test methods based on the model of pharmacodynamic response, the characteristics of pharmacokinetics, and the species of experimental animals. The test can use in vivo and/or in vitro methods.

(2) The phase of research

Safety pharmacology research runs through the entire process of new drug research and can be carried out in stages. Before the drug enters the clinical trial, the study of the core battery (Core Battery) test for the effects on the central nervous system, cardiovascular system and respiratory system should be completed. Additional and/or supplementary safety pharmacology studies can be completed before application for clinical or production, depending on the specific circumstances.

(3) Requirements for implementing GLP

Drug safety evaluation research must implement the “Non-clinical Drug Research Quality Management Practice” (GLP). In principle, safety pharmacology studies must perform GLP. For some special cases that are difficult to meet GLP requirements, proper test management and data storage must also be ensured. The core combination test shall perform GLP. Supplementary or/and supplementary safety pharmacology studies should follow GLP specifications as much as possible.

(4) Test substance

Traditional Chinese medicine and natural medicine: The test substance should be a sample that can fully represent the quality and safety of the samples to be used in clinical trials and/or the samples on the market. The process should be prepared after the process route and key process parameters are determined. Generally, it should be a sample of a pilot scale or above, otherwise there should be sufficient reasons. The name, source, batch number, content (or specification), storage conditions, expiration date and preparation method of the test substance should be indicated, and a quality inspection report should be provided. Due to the particularity of traditional Chinese medicines, it is recommended to use them now, otherwise data should be provided to support the quality stability and uniformity of the test substance after preparation. When the administration time is longer, it should be investigated whether the volume after preparation is swelled with the prolonged storage time, causing the final concentration to be inaccurate. If the volume or method of administration is limited, the drug substance can be used for testing. The solvent and/or auxiliary materials used in the test should be marked with the name, standard, batch number, expiration date, specification and production unit.
Chemical drugs: The test substance should be a sample with relatively stable technology, purity and impurity content that can reflect the quality and safety of the samples to be used in clinical trials and/or the samples on the market. The test substance should be marked with the name, source, batch number, content (or specification), storage conditions, expiration date and preparation method, etc., and a quality inspection report should be provided. The solvent and/or auxiliary materials used in the test should be marked with the name, standard, batch number, expiration date, specifications and production unit, etc., and meet the test requirements.
In the process of drug development, if the process of the test substance changes that may affect its safety, corresponding safety studies should be carried out.
During the chemical drug test, the test substance sample should be analyzed, and the sample analysis report should be provided. Traditional Chinese medicines and natural medicines with basically clear ingredients should also be analyzed for test substance samples.

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