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Safety Pharmacology-ICH S7A and ICH S7B www.medicilon.comban site

Safety pharmacology (safety pharmacology) research is an important part of the non-clinical safety evaluation of new drugs when the dose of the main research drug is within the therapeutic range or above the therapeutic range. There are potential undesired adverse effects. And observed in the study / or speculated adverse drug reaction mechanism so as to maximize the protection of new drugs before entering clinical research or after marketing early detection of possible adverse reactions beyond the therapeutic effect. When some adverse reactions to humans and animals are observed or speculated in other non-clinical trials and clinical trials, safety pharmacology research should be added and supplemented. The objectives of safety pharmacology research include: ① determine the undesired pharmacological effects of drugs that may be related to human safety; ② evaluate the adverse drug reactions and (or) pathophysiology of drugs observed in toxicology and (or) clinical research ③ observed and (or) speculated adverse drug reaction mechanism. Safety pharmacology research runs through the whole process of new drug research and can be carried out in stages. The International Council for Harmonization of Technical Requirements for Registration of Drugs for Human Use (ICH) issued corresponding guidelines for the evaluation of safety pharmacology tests, which were formulated by the corresponding ICH expert groups according to the ICH procedures, and have now been adopted by the European Union, Japan and the United States. Medicilon can provide safe pharmacological experiment services using large and small animals to explore the effects of drugs on central nervous system, respiratory system and cardiovascular system, and to support drug R&D.https://www.medicilon.com/services/drug-safety-evaluation/
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