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14.
Rev Fac Cien Med Univ Nac Cordoba ; 80(2): 85-87, 2023 06 30.
Artigo em Espanhol | MEDLINE | ID: mdl-37402300

RESUMO

Editorial: Variability and discrepancies between Ethics Committees in the evaluation of academic research projects.


Editorial: Variabilidad y discrepancias entre Comités de Ética en la evaluación de proyectos de investigación académica.


Assuntos
Comitês de Ética em Pesquisa , Pesquisa , Humanos , Pesquisa/normas
17.
Zhongguo Zhong Yao Za Zhi ; 48(12): 3404-3408, 2023 Jun.
Artigo em Chinês | MEDLINE | ID: mdl-37382023

RESUMO

Amid the modernization and internationalization of traditional Chinese medicine(TCM), the safety of TCM has attracted much attention. At the moment, the government, scientific research teams, and pharmaceutical enterprises have made great efforts to explore methods and techniques for clinical safety evaluation of TCM. Although considerable achievements have been made, there are still many problems, such as the non-standard terms of adverse reactions of TCM, unclear evaluation indicators, unreasonable judgment methods, lack of evaluation models, out-of-date evaluation standards, and unsound reporting systems. Therefore, it is urgent to further deepen the research mode and method of clinical safety evaluation of TCM. Based on the current national requirements for the life-cycle management of drugs, this study focused on the problems in the five dimensions of clinical safety evaluation of TCM, including normative terms, evaluation modes, judgment methods, evaluation standards, and reporting systems, and proposed suggestions on the development of a life-cycle clinical safety evaluation method that conformed to the characteristics of TCM, hoping to provide a reference for future research.


Assuntos
Avaliação de Medicamentos , Medicina Tradicional Chinesa , Medicina Tradicional Chinesa/normas , Avaliação de Medicamentos/métodos , Avaliação de Medicamentos/normas , Avaliação de Medicamentos/tendências , Indústria Farmacêutica/normas , Indústria Farmacêutica/tendências , Pesquisa/normas , Pesquisa/tendências , Humanos
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