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儿童高风险医疗器械临床试验的证据:范围审查

Kathrin Guerlich1,2, Bernadeta Patro-Golab1, Paulina Dworakowski3

  • 1LMU-Ludwig Maximilians Universität Munich, Division of Metabolic and Nutritional Medicine, Department of Pediatrics, Dr. von Hauner Children's Hospital, LMU University Hospital, Munich, Germany.

Pediatric research
|September 27, 2023
PubMed
概括

高风险儿科医疗器械的临床试验往往缺乏并发控制,并很少招收幼儿. 本综述强调了儿科器械研究和监管合规性方面的挑战.

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