Risk assessment in drug development for symptomatic indications: A framework for the prospective exclusion of unacceptable cardiovascular risk
2006; Wiley; Volume: 79; Issue: 3 Linguagem: Inglês
10.1016/j.clpt.2005.11.012
ISSN1532-6535
AutoresEric P. Brass, Robert A. Lewis, Raymond J. Lipicky, James R. Murphy, William R. Hiatt,
Tópico(s)Pharmaceutical Economics and Policy
ResumoClinical Pharmacology & TherapeuticsVolume 79, Issue 3 p. 165-172 Commentary Risk assessment in drug development for symptomatic indications: A framework for the prospective exclusion of unacceptable cardiovascular risk Eric P. Brass MD, PhD, Eric P. Brass MD, PhD Department of Medicine, Section of Vascular Medicine, University of Colorado Health Sciences Center, Colorado Prevention Center, and National Jewish Medical and Research Center, Denver Center for Clinical Pharmacology and Department of Emergency Medicine, Harbor-UCLA Medical Center, and Los Angeles Biomedical Research Institute, Torrance LIPICKY, LLC, GaithersburgSearch for more papers by this authorRoger J. Lewis MD, PhD, Roger J. Lewis MD, PhD Department of Medicine, Section of Vascular Medicine, University of Colorado Health Sciences Center, Colorado Prevention Center, and National Jewish Medical and Research Center, Denver Center for Clinical Pharmacology and Department of Emergency Medicine, Harbor-UCLA Medical Center, and Los Angeles Biomedical Research Institute, Torrance LIPICKY, LLC, GaithersburgSearch for more papers by this authorRaymond Lipicky MD, Raymond Lipicky MD Department of Medicine, Section of Vascular Medicine, University of Colorado Health Sciences Center, Colorado Prevention Center, and National Jewish Medical and Research Center, Denver Center for Clinical Pharmacology and Department of Emergency Medicine, Harbor-UCLA Medical Center, and Los Angeles Biomedical Research Institute, Torrance LIPICKY, LLC, GaithersburgSearch for more papers by this authorJames Murphy PhD, James Murphy PhD Department of Medicine, Section of Vascular Medicine, University of Colorado Health Sciences Center, Colorado Prevention Center, and National Jewish Medical and Research Center, Denver Center for Clinical Pharmacology and Department of Emergency Medicine, Harbor-UCLA Medical Center, and Los Angeles Biomedical Research Institute, Torrance LIPICKY, LLC, GaithersburgSearch for more papers by this authorWilliam R. Hiatt MD, Corresponding Author William R. Hiatt MD Department of Medicine, Section of Vascular Medicine, University of Colorado Health Sciences Center, Colorado Prevention Center, and National Jewish Medical and Research Center, Denver Center for Clinical Pharmacology and Department of Emergency Medicine, Harbor-UCLA Medical Center, and Los Angeles Biomedical Research Institute, Torrance LIPICKY, LLC, GaithersburgWilliam R. Hiatt, MD, University of Colorado Health Sciences Center, Colorado Prevention Center, 789 Sherman St, Suite 200, Denver, CO, 80203. E-mail: [email protected]Search for more papers by this author Eric P. Brass MD, PhD, Eric P. Brass MD, PhD Department of Medicine, Section of Vascular Medicine, University of Colorado Health Sciences Center, Colorado Prevention Center, and National Jewish Medical and Research Center, Denver Center for Clinical Pharmacology and Department of Emergency Medicine, Harbor-UCLA Medical Center, and Los Angeles Biomedical Research Institute, Torrance LIPICKY, LLC, GaithersburgSearch for more papers by this authorRoger J. Lewis MD, PhD, Roger J. Lewis MD, PhD Department of Medicine, Section of Vascular Medicine, University of Colorado Health Sciences Center, Colorado Prevention Center, and National Jewish Medical and Research Center, Denver Center for Clinical Pharmacology and Department of Emergency Medicine, Harbor-UCLA Medical Center, and Los Angeles Biomedical Research Institute, Torrance LIPICKY, LLC, GaithersburgSearch for more papers by this authorRaymond Lipicky MD, Raymond Lipicky MD Department of Medicine, Section of Vascular Medicine, University of Colorado Health Sciences Center, Colorado Prevention Center, and National Jewish Medical and Research Center, Denver Center for Clinical Pharmacology and Department of Emergency Medicine, Harbor-UCLA Medical Center, and Los Angeles Biomedical Research Institute, Torrance LIPICKY, LLC, GaithersburgSearch for more papers by this authorJames Murphy PhD, James Murphy PhD Department of Medicine, Section of Vascular Medicine, University of Colorado Health Sciences Center, Colorado Prevention Center, and National Jewish Medical and Research Center, Denver Center for Clinical Pharmacology and Department of Emergency Medicine, Harbor-UCLA Medical Center, and Los Angeles Biomedical Research Institute, Torrance LIPICKY, LLC, GaithersburgSearch for more papers by this authorWilliam R. Hiatt MD, Corresponding Author William R. Hiatt MD Department of Medicine, Section of Vascular Medicine, University of Colorado Health Sciences Center, Colorado Prevention Center, and National Jewish Medical and Research Center, Denver Center for Clinical Pharmacology and Department of Emergency Medicine, Harbor-UCLA Medical Center, and Los Angeles Biomedical Research Institute, Torrance LIPICKY, LLC, GaithersburgWilliam R. Hiatt, MD, University of Colorado Health Sciences Center, Colorado Prevention Center, 789 Sherman St, Suite 200, Denver, CO, 80203. E-mail: [email protected]Search for more papers by this author First published: 07 February 2006 https://doi.org/10.1016/j.clpt.2005.11.012Citations: 6Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onEmailFacebookTwitterLinkedInRedditWechat References 1Okie, S. (2005). Safety in numbers—monitoring risk in approved drugs. N Engl J Med 352: 1173–1176. 2Brophy, J. M. (2005). Selling safety—lessons from muraglitazar. JAMA 294: 2633–2635. 3Stevenson, L. W. (1998). Inotropic therapy for heart failure. 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