| Pregnancy exposure registries: academic opportunities and industry responsibility. | |
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MedLine Citation:
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PMID: 19107953 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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Diego F Wyszynski |
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Publication Detail:
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Type: Journal Article; Research Support, Non-U.S. Gov't; Review |
Journal Detail:
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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:
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Created Date: 2009-01-15 Completed Date: 2009-02-13 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 101155107 Medline TA: Birth Defects Res A Clin Mol Teratol Country: United States |
Other Details:
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Languages: eng Pagination: 93-101 Citation Subset: IM |
Affiliation:
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Amgen Inc, Global Regulatory Affairs and Safety, One Amgen Center Drive, Thousand Oaks, California 91320, USA. diegow@amgen.com |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Abnormalities, Drug-Induced
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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:
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0/Pharmaceutical Preparations |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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