| Better data needed from pregnancy registries. | |
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MedLine Citation:
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PMID: 19107958 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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This article is a consensus position statement from the Research Committee of the Organization of Teratology Information Specialists (OTIS). The Committee believes that more specific information on the timing and dose of drug exposures from pregnancy birth defect registries sponsored by pharmaceutical companies (herein called pregnancy registries) would improve the estimation of risk for developmental toxicity (i.e., growth alteration, structural anomalies, functional/neurobehavioral deficits, or death). Specifically, the Committee believes that the exposure timing should be stated in gestational weeks and days rather than simply weeks. In addition, the Committee believes that the exposure dose should be stated in patient-specific terms, such as body weight (mg/kg) or body surface area (mg/m(2)) rather than simply dose strength. Although the focus of this position is pregnancy registries, it also is applicable to any source of medication-induced embryo-fetal toxicity. |
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Authors:
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Gerald G Briggs; Janine Polifka; |
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Publication Detail:
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Type: Evaluation Studies; Journal Article |
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 Feb |
Date Detail:
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Created Date: 2009-02-12 Completed Date: 2009-04-14 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: 109-11 Citation Subset: IM |
Copyright Information:
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(c) 2008 Wiley-Liss, Inc. |
Affiliation:
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Perinatal Support Service, MemorialCare Center for Women, Miller Children's Hospital, Long Beach Memorial Medical Center, Long Beach, CA 90806, USA. jbriggs@memorialcare.org |
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* Congenital Abnormalities / epidemiology*, etiology Consensus Dose-Response Relationship, Drug Female Humans Pharmaceutical Preparations / adverse effects* Pregnancy Prenatal Exposure Delayed Effects / chemically induced, epidemiology Product Surveillance, Postmarketing / methods, standards Registries* Risk Factors Time Factors |
| Chemical | |
Reg. No./Substance:
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0/Pharmaceutical Preparations |
| Investigator | |
Investigator/Affiliation:
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Elizabeth Balken / ; Anick Berard / ; Stephen Braddock / ; Gerald Briggs / ; Christina Chambers / ; Adrienne Einarson / ; Cecilia Lyons Gaffaney / ; Mara Gaudette / ; Gideon Koren / ; Kenneth Jones / ; Steve Lamm / ; Richard Miller / ; Janine Polifka / ; Sara Riordan / ; Luther Robinson / ; Offie Soldin / ; Katherine Wisner / ; Lori Wolfe / |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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