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Search Images and Extrapolation Risk—Reply

Search Images and Extrapolation Risk—Reply Letters 7. Fadiran EO, Zhang L. Effects of Sex Differences in the Pharmacokinetics of fulfill different purposes, which may lead to differences in the Drugs and Their Impact on the Safety of Medicines in Women. In: number of sex-specific statements. Harrison-Woolrych M, ed. Medicines For Women. Cham: Springer International The label is a regulatory document meant to provide a sum- Publishing; 2015:41-68. mary of the scientific information needed for the safe and ef- fective use of the drug. The drug label cannot contain effi- cacy claims for subpopulations if the evidence for such claims Search Images and Extrapolation Risk does not meet the “substantial evidence” standard. Unlike the To the Editor An Original Investigation by Halpern and 1 2 required subsections for geriatric and pediatric age (sections colleagues and Invited Commentary by Subak and Grady, both 8.4 and 8.5), which must be included in labeling regardless published in a recent issue of JAMA Internal Medicine, sug- of whether there is informative data, sex demographic infor- gest that evaluation of asymptomatic microscopic hematuria mation is not a required subsection. What data on sex-based may not be cost-effective. Their focus was on subsequent rec- differences to include is determined during the http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA Internal Medicine American Medical Association

Search Images and Extrapolation Risk—Reply

JAMA Internal Medicine , Volume 177 (12) – Dec 1, 2017

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References (2)

Publisher
American Medical Association
Copyright
Copyright 2017 American Medical Association. All Rights Reserved.
ISSN
2168-6106
eISSN
2168-6114
DOI
10.1001/jamainternmed.2017.5097
Publisher site
See Article on Publisher Site

Abstract

Letters 7. Fadiran EO, Zhang L. Effects of Sex Differences in the Pharmacokinetics of fulfill different purposes, which may lead to differences in the Drugs and Their Impact on the Safety of Medicines in Women. In: number of sex-specific statements. Harrison-Woolrych M, ed. Medicines For Women. Cham: Springer International The label is a regulatory document meant to provide a sum- Publishing; 2015:41-68. mary of the scientific information needed for the safe and ef- fective use of the drug. The drug label cannot contain effi- cacy claims for subpopulations if the evidence for such claims Search Images and Extrapolation Risk does not meet the “substantial evidence” standard. Unlike the To the Editor An Original Investigation by Halpern and 1 2 required subsections for geriatric and pediatric age (sections colleagues and Invited Commentary by Subak and Grady, both 8.4 and 8.5), which must be included in labeling regardless published in a recent issue of JAMA Internal Medicine, sug- of whether there is informative data, sex demographic infor- gest that evaluation of asymptomatic microscopic hematuria mation is not a required subsection. What data on sex-based may not be cost-effective. Their focus was on subsequent rec- differences to include is determined during the

Journal

JAMA Internal MedicineAmerican Medical Association

Published: Dec 1, 2017

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