Document Detail


Pregnancy exposure registries: academic opportunities and industry responsibility.
MedLine Citation:
PMID:  19107953     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Pregnancy exposure registries systematically evaluate pregnancies and outcomes exposed to a medicinal compound or device during the gestational period. Historically, such programs partner an academic institution with one or more pharmaceutical companies or are run solely by a pharmaceutical company. However, other examples abound. This article describes what a pregnancy exposure registry is, as well as selected methodological challenges they face, using real examples and applications.
Authors:
Diego F Wyszynski
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't; Review    
Journal Detail:
Title:  Birth defects research. Part A, Clinical and molecular teratology     Volume:  85     ISSN:  1542-0760     ISO Abbreviation:  Birth Defects Res. Part A Clin. Mol. Teratol.     Publication Date:  2009 Jan 
Date Detail:
Created Date:  2009-01-15     Completed Date:  2009-02-13     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101155107     Medline TA:  Birth Defects Res A Clin Mol Teratol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  93-101     Citation Subset:  IM    
Affiliation:
Amgen Inc, Global Regulatory Affairs and Safety, One Amgen Center Drive, Thousand Oaks, California 91320, USA. diegow@amgen.com
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MeSH Terms
Descriptor/Qualifier:
Abnormalities, Drug-Induced / epidemiology*,  etiology
Adverse Drug Reaction Reporting Systems / standards*
Data Collection / methods
Databases, Factual / standards
Female
Humans
Infant, Newborn
Pharmaceutical Preparations / adverse effects*
Pregnancy
Pregnancy Complications / drug therapy*
Pregnancy Outcome
Registries / standards*
Chemical
Reg. No./Substance:
0/Pharmaceutical Preparations

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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