Assessment and reporting of clinical pharmacology information in drug labeling
2000; Wiley; Volume: 67; Issue: 3 Linguagem: Inglês
10.1067/mcp.2000.104737
ISSN1532-6535
AutoresDaniel A. Spyker, Emily Harvey, B Harvey, Alice Harvey, Barry H. Rumack, Carl C. Peck, A ATKINSONJR, Raymond L. Woosley, D. R. Abernethy, Louis R. Cantilena,
Tópico(s)Pharmacovigilance and Adverse Drug Reactions
ResumoClinical Pharmacology & TherapeuticsVolume 67, Issue 3 p. 196-200 Commentary Assessment and reporting of clinical pharmacology information in drug labeling Daniel A. Spyker PhD, MD, Corresponding Author Daniel A. Spyker PhD, MD [email protected] Purdue Pharma L.P., Norwalk Center for Devices and Radiological Health, US Food and Drug Administration, Rockville Brigham and Women's Hospital, Boston Rocky Mountain Poison and Drug Center, Denver Georgetown University, Washington Clinical Center, National Institutes of Health, Uniformed Services University of the Health Sciences, Bethesda, MdPurdue Pharma L.P., 100 Connecticut Ave, Norwalk, CT 06850-3690.Search for more papers by this authorElisa D. Harvey PhD, DVM, Elisa D. Harvey PhD, DVM Purdue Pharma L.P., Norwalk Center for Devices and Radiological Health, US Food and Drug Administration, Rockville Brigham and Women's Hospital, Boston Rocky Mountain Poison and Drug Center, Denver Georgetown University, Washington Clinical Center, National Institutes of Health, Uniformed Services University of the Health Sciences, Bethesda, MdSearch for more papers by this authorBrian E. Harvey MD, PhD, Brian E. Harvey MD, PhD Purdue Pharma L.P., Norwalk Center for Devices and Radiological Health, US Food and Drug Administration, Rockville Brigham and Women's Hospital, Boston Rocky Mountain Poison and Drug Center, Denver Georgetown University, Washington Clinical Center, National Institutes of Health, Uniformed Services University of the Health Sciences, Bethesda, MdSearch for more papers by this authorAlan M. Harvey MD, MBA, Alan M. Harvey MD, MBA Purdue Pharma L.P., Norwalk Center for Devices and Radiological Health, US Food and Drug Administration, Rockville Brigham and Women's Hospital, Boston Rocky Mountain Poison and Drug Center, Denver Georgetown University, Washington Clinical Center, National Institutes of Health, Uniformed Services University of the Health Sciences, Bethesda, MdSearch for more papers by this authorBarry H. Rumack MD, Barry H. Rumack MD Purdue Pharma L.P., Norwalk Center for Devices and Radiological Health, US Food and Drug Administration, Rockville Brigham and Women's Hospital, Boston Rocky Mountain Poison and Drug Center, Denver Georgetown University, Washington Clinical Center, National Institutes of Health, Uniformed Services University of the Health Sciences, Bethesda, MdSearch for more papers by this authorCarl C. Peck MD, Carl C. Peck MD Purdue Pharma L.P., Norwalk Center for Devices and Radiological Health, US Food and Drug Administration, Rockville Brigham and Women's Hospital, Boston Rocky Mountain Poison and Drug Center, Denver Georgetown University, Washington Clinical Center, National Institutes of Health, Uniformed Services University of the Health Sciences, Bethesda, MdSearch for more papers by this authorArthur J. Atkinson Jr MD, Arthur J. Atkinson Jr MD Purdue Pharma L.P., Norwalk Center for Devices and Radiological Health, US Food and Drug Administration, Rockville Brigham and Women's Hospital, Boston Rocky Mountain Poison and Drug Center, Denver Georgetown University, Washington Clinical Center, National Institutes of Health, Uniformed Services University of the Health Sciences, Bethesda, MdSearch for more papers by this authorRaymond L. Woosley MD, PhD, Raymond L. Woosley MD, PhD Purdue Pharma L.P., Norwalk Center for Devices and Radiological Health, US Food and Drug Administration, Rockville Brigham and Women's Hospital, Boston Rocky Mountain Poison and Drug Center, Denver Georgetown University, Washington Clinical Center, National Institutes of Health, Uniformed Services University of the Health Sciences, Bethesda, MdSearch for more papers by this authorDarrell R. Abernethy MD, PhD, Darrell R. Abernethy MD, PhD Purdue Pharma L.P., Norwalk Center for Devices and Radiological Health, US Food and Drug Administration, Rockville Brigham and Women's Hospital, Boston Rocky Mountain Poison and Drug Center, Denver Georgetown University, Washington Clinical Center, National Institutes of Health, Uniformed Services University of the Health Sciences, Bethesda, MdSearch for more papers by this authorLouis R. Cantilena MD, PhD, Louis R. Cantilena MD, PhD Purdue Pharma L.P., Norwalk Center for Devices and Radiological Health, US Food and Drug Administration, Rockville Brigham and Women's Hospital, Boston Rocky Mountain Poison and Drug Center, Denver Georgetown University, Washington Clinical Center, National Institutes of Health, Uniformed Services University of the Health Sciences, Bethesda, MdSearch for more papers by this author Daniel A. Spyker PhD, MD, Corresponding Author Daniel A. Spyker PhD, MD [email protected] Purdue Pharma L.P., Norwalk Center for Devices and Radiological Health, US Food and Drug Administration, Rockville Brigham and Women's Hospital, Boston Rocky Mountain Poison and Drug Center, Denver Georgetown University, Washington Clinical Center, National Institutes of Health, Uniformed Services University of the Health Sciences, Bethesda, MdPurdue Pharma L.P., 100 Connecticut Ave, Norwalk, CT 06850-3690.Search for more papers by this authorElisa D. Harvey PhD, DVM, Elisa D. Harvey PhD, DVM Purdue Pharma L.P., Norwalk Center for Devices and Radiological Health, US Food and Drug Administration, Rockville Brigham and Women's Hospital, Boston Rocky Mountain Poison and Drug Center, Denver Georgetown University, Washington Clinical Center, National Institutes of Health, Uniformed Services University of the Health Sciences, Bethesda, MdSearch for more papers by this authorBrian E. Harvey MD, PhD, Brian E. Harvey MD, PhD Purdue Pharma L.P., Norwalk Center for Devices and Radiological Health, US Food and Drug Administration, Rockville Brigham and Women's Hospital, Boston Rocky Mountain Poison and Drug Center, Denver Georgetown University, Washington Clinical Center, National Institutes of Health, Uniformed Services University of the Health Sciences, Bethesda, MdSearch for more papers by this authorAlan M. Harvey MD, MBA, Alan M. Harvey MD, MBA Purdue Pharma L.P., Norwalk Center for Devices and Radiological Health, US Food and Drug Administration, Rockville Brigham and Women's Hospital, Boston Rocky Mountain Poison and Drug Center, Denver Georgetown University, Washington Clinical Center, National Institutes of Health, Uniformed Services University of the Health Sciences, Bethesda, MdSearch for more papers by this authorBarry H. Rumack MD, Barry H. Rumack MD Purdue Pharma L.P., Norwalk Center for Devices and Radiological Health, US Food and Drug Administration, Rockville Brigham and Women's Hospital, Boston Rocky Mountain Poison and Drug Center, Denver Georgetown University, Washington Clinical Center, National Institutes of Health, Uniformed Services University of the Health Sciences, Bethesda, MdSearch for more papers by this authorCarl C. Peck MD, Carl C. Peck MD Purdue Pharma L.P., Norwalk Center for Devices and Radiological Health, US Food and Drug Administration, Rockville Brigham and Women's Hospital, Boston Rocky Mountain Poison and Drug Center, Denver Georgetown University, Washington Clinical Center, National Institutes of Health, Uniformed Services University of the Health Sciences, Bethesda, MdSearch for more papers by this authorArthur J. Atkinson Jr MD, Arthur J. Atkinson Jr MD Purdue Pharma L.P., Norwalk Center for Devices and Radiological Health, US Food and Drug Administration, Rockville Brigham and Women's Hospital, Boston Rocky Mountain Poison and Drug Center, Denver Georgetown University, Washington Clinical Center, National Institutes of Health, Uniformed Services University of the Health Sciences, Bethesda, MdSearch for more papers by this authorRaymond L. Woosley MD, PhD, Raymond L. Woosley MD, PhD Purdue Pharma L.P., Norwalk Center for Devices and Radiological Health, US Food and Drug Administration, Rockville Brigham and Women's Hospital, Boston Rocky Mountain Poison and Drug Center, Denver Georgetown University, Washington Clinical Center, National Institutes of Health, Uniformed Services University of the Health Sciences, Bethesda, MdSearch for more papers by this authorDarrell R. Abernethy MD, PhD, Darrell R. Abernethy MD, PhD Purdue Pharma L.P., Norwalk Center for Devices and Radiological Health, US Food and Drug Administration, Rockville Brigham and Women's Hospital, Boston Rocky Mountain Poison and Drug Center, Denver Georgetown University, Washington Clinical Center, National Institutes of Health, Uniformed Services University of the Health Sciences, Bethesda, MdSearch for more papers by this authorLouis R. Cantilena MD, PhD, Louis R. Cantilena MD, PhD Purdue Pharma L.P., Norwalk Center for Devices and Radiological Health, US Food and Drug Administration, Rockville Brigham and Women's Hospital, Boston Rocky Mountain Poison and Drug Center, Denver Georgetown University, Washington Clinical Center, National Institutes of Health, Uniformed Services University of the Health Sciences, Bethesda, MdSearch for more papers by this author First published: 26 March 2000 https://doi.org/10.1067/mcp.2000.104737Citations: 8 No financial support was received for this study. Presented at the Ninety-eighth Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, San Diego, March 5-8, 1997 California (abstract: Clin Pharmacol Ther 1997;61:166). Read 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 References 1 Physicians' desk reference. (1996). 50th ed. Medical Economics: Medical Montvale (NJ). 2 Drug Evaluations Annual. (1995). American Medical Association, Division of Drugs and Toxicology: Chicago (IL). 3Mullen, W. H., Anderson, I. B., Kim, S. Y., Blanc, P. D. and Olson, K. R. (1997). Incorrect overdose management advice in the Physicians' Desk Reference. Annals Emerg Med 29: 255– 261. Citing Literature Volume67, Issue3March 2000Pages 196-200 ReferencesRelatedInformation
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