Questioning the Design of Non-Inferiority Trials: The Strange Case for Therapeutic Drug Monitoring Absence in Phase III Trials.
作者信息
Lemaitre Florian, Lalanne Sébastien, Verdier Marie-Clémence
机构信息
Univ Rennes, CHU Rennes, EHESP, Irset (Institut de recherche en santé, environnement et travail) - UMR S 1085, Rennes, France.
INSERM, Centre d'Investigation Clinique 1414, Rennes, France.
出版信息
Clin Pharmacol Ther. 2025 Jan;117(1):25-27. doi: 10.1002/cpt.3408. Epub 2024 Aug 9.
Abstract
摘要
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Questioning the Design of Non-Inferiority Trials: The Strange Case for Therapeutic Drug Monitoring Absence in Phase III Trials.对非劣效性试验设计的质疑：III期试验中缺乏治疗药物监测的奇怪案例。
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