China specific drugs bioequivalence technical guidance summary and consideration
Bioequivalence is an important method to evaluate the consistency of quality and efficacy between generic drug and original drug.The scientificity of test method,applicability of evaluation criteria and standardization of data directly affect the evaluation accuracy of generic drug.In this paper,48 technical guidelines for bioequivalence of specific drugs(including 16 draft for comment)released since August 2020 in China were summarized and sorted,and guidelines for bioequivalence research of specific drugs have been summarized from multiple dimensions.Combined with the relevant experience of international advanced regulatory agencies such as United States,European Union and Japan,in order to improve the quality and efficacy of generic drugs in China,further meet the clinical require of patients and reduce the burden of medication,general considerations were put forward for China bioequivalence guidelines of specific drugs.
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