Effect of Study Design on Sample Size in Studies Intended to Evaluate Bioequivalence of Inhaled Short-Acting β-Agonist Formulations.

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作者： Yaohui,Zeng ^[1] ; Sachinkumar,Singh ^[2] ; Kai,Wang ^[1] ; Richard C,Ahrens ^[2]

作者单位： Department of Biostatistics, College of Public Health, University of Iowa, Iowa City, IA, USA. ^[1] Stead Family Department of Pediatrics, Carver College of Medicine, University of Iowa, Iowa City, IA, USA. ^[2]

关键词 Emax model Monte Carlo simulation asthma cost analysis pharmacodynamics

主题词投药, 吸入(Administration, Inhalation);肾上腺素能β激动剂(Adrenergic beta-Agonists);哮喘(Asthma);支气管收缩药(Bronchoconstrictor Agents);支气管扩张药(Bronchodilator Agents);临床试验(主题)(Clinical Trials as Topic);成本及成本分析(Costs and Cost Analysis);人类(Humans);氯醋甲胆碱(Methacholine Chloride);蒙特卡罗法(Monte Carlo Method);研究设计(Research Design);治疗等效(Therapeutic Equivalency);美国(United States);美国食品和药物管理局(United States Food and Drug Administration)

DOI 10.1002/jcph.1045

PMID 29281130

发布时间 2019-05-03

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Journal of clinical pharmacology

2018年58卷4期

457-465页

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Effect of Study Design on Sample Size in Studies Intended to Evaluate Bioequivalence of Inhaled Short-Acting β-Agonist Formulations.

Journal of clinical pharmacology

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Journal of clinical pharmacology

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Effect of Study Design on Sample Size in Studies Intended to Evaluate Bioequivalence of Inhaled Short-Acting β-Agonist Formulations.

Journal of clinical pharmacology

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Journal of clinical pharmacology

相关期刊

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