Abstract
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/m2) 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.
Original language | English (US) |
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Pages (from-to) | 109-111 |
Number of pages | 3 |
Journal | Birth Defects Research Part A - Clinical and Molecular Teratology |
Volume | 85 |
Issue number | 2 |
DOIs | |
State | Published - Feb 2009 |
Externally published | Yes |
Keywords
- Exposure dose
- Exposure timing
- Pregnancy registries
ASJC Scopus subject areas
- Developmental Biology
- Pediatrics, Perinatology, and Child Health
- Embryology