期刊文献+

新药临床研究的可变剂量设计 被引量:5

Design of dose titration in clinical trial of new drug
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摘要 新药研究中剂量与效应关系研究贯穿于各期临床试验中,可变剂量设计具有一定优势。本文列出了设计类型、特点和注意事项,另外用一个降血脂实例进行说明。 Titration to optimal effect is the central principle in the treatment of diseases with medications, and an important approach for the study of dose-response relationship. This paper lists different types, characteristics and important points in the design. An example of rosuvastain calcium is given by the design in clinical trail.
出处 《中国临床药理学与治疗学》 CAS CSCD 2005年第4期479-480,共2页 Chinese Journal of Clinical Pharmacology and Therapeutics
关键词 临床试验 量效关系 试验设计 血脂 可变剂量 剂量滴定 瑞舒伐他汀 clinical trial dose-response relationship changeable dose design blood lipid trail design rosuvastatin
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参考文献4

  • 1ICH E8. General Considerations for Clinical Trials. http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/e8e.html
  • 2Paoletti R, Fahmy M, Mahla G, Mizan J, Southworth H. Rosuvastatin demonstrates greater reduction of low-density lipoprotein cholesterol compared with pravastatin and simvastatin in hypercholesterolaemic patients: a randomized, double-blind study. J Cardior Risk. 2001;8:383-390
  • 3Brown W, Bays H, Hassman D, McKenney J, Chitra R, Hutchinson H, Miller E. Efficacy and safety of rosuvastatin compared with pravastatin and simvastatin in patients with hypercholesterolemia: A randomized, double-blind, 52-week trial. American Heart Journal 2002;144(6):1036-1043
  • 4Martin PD, Mitchell PD, Schneck DW. Pharmacodynamic effects and pharmacokinetics of a new HMG-CoA reductase inhibitor, rosuvastatin, after morning or evening administration in healthy volunteers. BJCP, 2002; 54:472

同被引文献33

  • 1李攻戍,张毅,翁维良.中药新药I期临床试验设计的几个问题[J].中药新药与临床药理,2005,16(2):79-81. 被引量:15
  • 2林友平,彭凌艳,陈颖.复方鱼腥草滴丸治疗急性咽炎和急性卡他性扁桃体炎的临床观察[J].中国中西医结合耳鼻咽喉科杂志,2007,15(2):123-125. 被引量:11
  • 3杨民杰,杨宝峰,王怀良.药理学[M].北京:人民卫生出版社,2005:6-19.
  • 4IVANOVA A, BOLOGNESE JA. Perevozskaya I. Adaptive dose finding based on t-statistic for dose-response trials [ J ]. Statist Med,2008,27(10) :1581 - 1592.
  • 5ICH E8, General Considerations for Clinical Trials [ DB/OL], ( 1998 - 05 ). European Medicines Agency. http ://www. emea. europa, eu/pdfs/human/ich/029195 en. pdf.
  • 6ICH E4. Dose response information to support drug registration E4 [DB/OL]. ( 1994 - 11 ). European Medicines Agency. http:// www. emea. europa, eu/pdfs/human/ich/037895en, pdf.
  • 7CHOW SC, CHANG M. Adaptive Design Methods in Clinical Trials [ M ]. United States of America : Chapman & Hall/CRC ,2007 : 89 - 105.
  • 8YOSHIMURA I,WAKANA A. A performance comparison of maximum contrast method to detect dose dependency [ J ]. Drug lnf J, 1997,31 (2) :423 -432.
  • 9BRETZ F, HSU J, PINHEIRO J,et al. Dose Finding-A Challenge in Statistics[J]. Biota J,2008,50(4) :480 -504.
  • 10BRETZ F, PINHEIRO JC, BRANSON M. Combining multiple comparisons and modeling techniques in dose-response studies [ J]. Biota J,2005,61 ( 3 ) :738 - 748.

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