Characterization of dose-response for count data using a generalized MCP-Mod approach in an adaptive dose-ranging trial.

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作者： Francois,Mercier ^[1] ; Bjoern,Bornkamp ^[2] ; David,Ohlssen ^[3] ; Erik,Wallstroem ^[2]

作者单位： F. Hoffmann-La Roche Ltd., Clinical Pharmacology, Basel, Switzerland. ^[1] Novartis Pharma AG, Basel, Switzerland. ^[2] Novartis Pharmaceutical, East Hanover, NJ, USA. ^[3]

关键词 Emax model dose-finding multiple sclerosis non-linear regression optimal design two-stage design

主题词临床试验, Ⅱ期(主题)(Clinical Trials, Phase II as Topic);计算机模拟(Computer Simulation);数据说明, 统计(Data Interpretation, Statistical);剂量效应关系, 药物(Dose-Response Relationship, Drug);人类(Humans);免疫因子类(Immunologic Factors);线性模型(Linear Models);磁共振成像(Magnetic Resonance Imaging);多发性硬化, 复发缓解性(Multiple Sclerosis, Relapsing-Remitting);非线性动力学(Nonlinear Dynamics);研究设计(Research Design);时间因素(Time Factors);治疗结果(Treatment Outcome);偏差(Uncertainty)

DOI 10.1002/pst.1693

PMID 26083135

发布时间 2015-07-16

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Pharmaceutical statistics

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Characterization of dose-response for count data using a generalized MCP-Mod approach in an adaptive dose-ranging trial.

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Characterization of dose-response for count data using a generalized MCP-Mod approach in an adaptive dose-ranging trial.

Pharmaceutical statistics

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Pharmaceutical statistics

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