百度试题 题目人体首次临床试验的最大推荐起始剂量(Maximum Recommended Starting Dose,MRSD),应是? A.预期在人体出现首次不良反应的剂量B.患者出现无法耐受的剂量C.预期在人体不出现不良反应的剂量相关知识点: 试题来源: 解析 C 反馈 收藏
人体首次临床试验的最大推荐起始剂量(Maximum Recommended Starting Dose,MRSD),应是? A. 预期在人体出现首次不良反应的剂量 B. 患者出现无法耐受的剂量 C. 预期在人体不出现不良反应的剂量 题目标签:剂量人体如何将EXCEL生成题库手机刷题 如何制作自己的在线小题库 > 手机使用 分享 反馈 收藏 举报 ...
WileyClinical Pharmacology & TherapeuticsChan G, Gray P, Glue P. An evaluation of the FDA draft guidance for estimating the maximum recommended starting dose (MRSD) for first-in-human (FIH) studies. Clin Pharmacol Ther. 2004;75(2):8.
An evaluation of the FDA draft guidance for estimating the maximum recommended starting dose (MRSD) for first-in-human (FIH) studiesAn algorithm for estimating the MRSD for FIH clinical trials was recently proposed by the FDA. To examine the relationship between the MRSDs and clinical findings ...
Although a dose lower than the MRSD can be used as the actual starting dose, the process described in this guidance will derive the maximum recommended starting dose. This algorithm generates an MRSD in units of mg/kg, a common method of dosing used in phase 1 trials, but the equations ...
ICH S6 recommended that the route and frequency of administration should be as close as possible to that proposed for clinical use and consideration could be given to the effects of volume, concentration, formulation, and site of administration suggesting the acceptability of a maximum feasible dose...
CLINICAL PHARMACOLOGY AND THERAPEUTICS -ST LOUIS-ChanG.GrayP.GlueChan G, Gray P, Glue P. An evaluation of the FDA draft guidance for estimating the maximum recommended starting dose (MRSD) for first-in-human (FIH) studies. Clin Pharmacol Ther. 2004;75(2):8....