The challenges of new drugs benefits and risks analysis: Lessons from the ximelagatran FDA Cardiovascular Advisory Committee
作者： Pol F. Boudes
DOI: 10.1016/J.CCT.2006.04.005
关键词:
摘要: … the critical path to a FDA Advisory Committee meeting. The ximelagatran program confirms that the direct inhibition of thrombin with an oral agent could meet an important medical need. …
elsevier.com
sci-hub.se 参考文章(19)
David M. Studdert, Troyen A. Brennan, Michelle M. Mello, Medical Monitoring for Pharmaceutical Injuries Agency for Healthcare Research and Quality. ,(2003)
Keith Powlison, The Path to Growth Harvard Business Review. ,vol. 80, pp. 132- ,(2002)
Ulf G. Eriksson, Ulf Bredberg, Kristina Gislén, Linda C. Johansson, Lars Frison, Martin Ahnoff, David Gustafsson, Pharmacokinetics and pharmacodynamics of ximelagatran, a novel oral direct thrombin inhibitor, in young healthy male subjects European Journal of Clinical Pharmacology. ,vol. 59, pp. 35- 43 ,(2003) , 10.1007/S00228-003-0565-7
Hyman J. Zimmerman, Hepatotoxicity: The Adverse Effects of Drugs and Other Chemicals on the Liver ,(1978)
Hyman J. Zimmerman, Drug-induced liver disease. Drugs. ,vol. 16, pp. 25- 45 ,(1978) , 10.2165/00003495-197816010-00002
Robert Temple, Susan S Ellenberg, None, Placebo-Controlled Trials and Active-Control Trials in the Evaluation of New Treatments. Part 1: Ethical and Scientific Issues Annals of Internal Medicine. ,vol. 133, pp. 455- 463 ,(2000) , 10.7326/0003-4819-133-6-200009190-00014
David M. Studdert, Michelle M. Mello, Troyen A. Brennan, Medical Monitoring for Pharmaceutical Injuries JAMA. ,vol. 289, pp. 889- 894 ,(2003) , 10.1001/JAMA.289.7.889
Benjamin Djulbegovic, Mike Clarke, Scientific and Ethical Issues in Equivalence Trials JAMA. ,vol. 285, pp. 1206- 1208 ,(2001) , 10.1001/JAMA.285.9.1206
S. J Day, Statistics Notes: Blinding in clinical trials and other studies BMJ. ,vol. 321, pp. 504- 504 ,(2000) , 10.1136/BMJ.321.7259.504
Martin R Tramèr, D John M Reynolds, R Andrew Moore, Henry J McQuay, When placebo controlled trials are essential and equivalence trials are inadequate. BMJ. ,vol. 317, pp. 875- 880 ,(1998) , 10.1136/BMJ.317.7162.875