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A history of drug regulation in the ...
~
Dowling College.
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A history of drug regulation in the United States 1902--2008: Effects on women's health.
Record Type:
Language materials, printed : Monograph/item
Title/Author:
A history of drug regulation in the United States 1902--2008: Effects on women's health./
Author:
Wessels-Cruz, Kathleen L.
Description:
231 p.
Notes:
Adviser: Albert Inserra.
Contained By:
Dissertation Abstracts International69-04A.
Subject:
Health Sciences, Pharmacy. -
Online resource:
http://pqdd.sinica.edu.tw/twdaoeng/servlet/advanced?query=3313053
ISBN:
9780549616177
A history of drug regulation in the United States 1902--2008: Effects on women's health.
Wessels-Cruz, Kathleen L.
A history of drug regulation in the United States 1902--2008: Effects on women's health.
- 231 p.
Adviser: Albert Inserra.
Thesis (Ed.D.)--Dowling College, 2008.
This study reviewed a history of drug research and regulation, federal policy, and pharmaceutical company involvement in the United States during the 20th century. The historical events that precipitated and formed legislation were analyzed.
ISBN: 9780549616177Subjects--Topical Terms:
1017737
Health Sciences, Pharmacy.
A history of drug regulation in the United States 1902--2008: Effects on women's health.
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231 p.
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Adviser: Albert Inserra.
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Source: Dissertation Abstracts International, Volume: 69-04, Section: A, page: 1515.
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Thesis (Ed.D.)--Dowling College, 2008.
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This study reviewed a history of drug research and regulation, federal policy, and pharmaceutical company involvement in the United States during the 20th century. The historical events that precipitated and formed legislation were analyzed.
520
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During the 20th century, clinical trials for testing the effects of a pharmacologic compound developed, as health events precipitated and legislation began to mandate their design. Women were excluded from clinical trials, both in the early part of the 1900s and later as clinical trials became more organized in the 1960s. The diethylstilbesterol and the thalidomide tragedies raised additional concern; in 1977, women were excluded from early phases of clinical drug trials because these drugs had resulted in death and deformity and raised public outcry for reform in the developing pharmaceutical industry.
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Additionally, women were excluded from clinical testing for the fear that they might be or could become pregnant while in a clinical study, and that a particular drug might have an unknown teratogenic effect on a developing fetus. This study investigated drug research and regulation in the United States during the last century, covering the period from 1902--2008 and analyzed the effects of policy on the exclusion of women in clinical trials and the impact on women's health. There is evidence that pharmacologic compounds act differently in men and women. The therapeutic area of endocrinology and reproductive biology, were the focus, as incidents and regulation in these areas were pivotal throughout the last century. An analysis of past and present policies was performed with recommendations for the future. Additionally, current and emerging drug issues were reviewed, as they may impact women's health.
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This study examined the progression of federal control and drug legislation, the events and tragedies that occurred, the effects that the legislation has had on the health of women and the nation, and the lack of the inclusion of women in clinical trials through a thorough review of public health policy, the Food and Drug Administration, and women's health issues during the twentieth century. This analysis provides an educational background for future policy makers, healthcare practitioners and for the women themselves.
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School code: 1395.
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http://pqdd.sinica.edu.tw/twdaoeng/servlet/advanced?query=3313053
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W9070383
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