Webfinding of toxicity has been identified, but definitive human data are unavailable. The guidance ... post-weaning (e.g., embryo-fetal death is a subset of mortality resulting … WebThe embryo or fetus may develop abnormally as a result of prenatal chemical exposure. This may show up as the existence of deformed organs, developmental delays, decreased functionality, full or partial organ agenesis, and fetal mortality . Independent of their toxicity to the mother, chemicals can directly impair fetal growth while pregnant.

Guidance for Industry - Food and Drug Administration

WebEmbryo-fetal toxicity: Based on the mechanism of action and animal studies. 胚・胎児毒性：作用機 序と動物実験に基づけば、アドセトリスは胎児に害を及ぼす可能性がありま … WebEnter the email address you signed up with and we'll email you a reset link. gaither tool company jacksonville il

Guidance for Industry

WebJan 15, 2024 · Methods: The aim of this study was to investigate the potential reproductive toxicity on embryo-fetal development of loxoprofen tromethamine (0, 1, 3, and 10 mg/kg/day) and sodium cyclophosphamide (CP) (2.8 mg/kg/day) administered by intravenous injection to pregnant rats during gestation days (GDs) 6-15. Pregnant rats … Web5.3 Embryo-Fetal Toxicity Trastuzumab products can cause fetal harm when administered to a pregnant woman. In post-marketing reports, use of trastuzumab during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. WebNov 5, 2008 · 2. Maternal toxicity. Most of the reports of T-2 toxin-exposure to pregnant mice and rats are focused on embryo/fetal toxicity, with little reference to maternal toxicity [ 13, 30 – 40 ]. Sehata et al. [ 41, 42] examined the maternal toxicity in detail in pregnant rats exposed to a single oral dose of T-2 toxin (2 mg/kg) on day 13 of gestation. gaither tour 2023