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The paper presents the aspects of the toxicity, specific activity, pharmacokinetics and pharmacodynamics of aceclofenac, given in various sources describing its preclinical studies.&#x0D;The search for information sources for the study was carried out using domestic and international databases: elibrary and PubMed using contextual queries, including terms of the international nonproprietary name, preclinical studies of pharmacokinetics, pharmacodynamics, and animal species.&#x0D;Aceclofenac is one of the most prescribed drugs for acute and chronic pain. It refers to non-steroidal anti-inflammatory drugs, considered as drugs of first choice in the treatment of inflammation and pain.&#x0D;On the pharmaceutical market of the Russian Federation, aceclofenac is presented in the form of tablets, powder for suspension preparation, cream for external use, which allows it to be prescribed for various diseases. It has shown itself to be highly effective in the symptomatic treatment of diseases of the musculoskeletal system, for the relief of acute and chronic pain.&#x0D;A review of preclinical studies materials cited in various literature sources and including aspects of studying the toxicity, specific activity, pharmacokinetics and pharmacodynamics of aceclofenac, in our opinion, will allow using the data obtained in our study as one of the tools for further registration of generics.

The aspects that describe the pre-clinical studies of aceclofenac, as an instrument of registration of a generic drug