Teratogenicity
The capacity of a drug or agent to cause structural or functional birth defects when administered during pregnancy. Most critical during organogenesis (weeks 3-8 in humans). Assessed in preclinical embryo-fetal development studies (ICH S5) in two species, and drugs are classified using the former FDA pregnancy categories (A-X) or the current Pregnancy and Lactation Labeling Rule (PLLR).
示例
- Thalidomide phocomelia (limb malformations)
- Isotretinoin (Accutane) craniofacial and cardiac defects
- Valproic acid neural tube defects (spina bifida)
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The capacity of a drug or agent to cause structural or functional birth defects when administered during pregnancy. Most critical during organogenesis (weeks 3-8 in humans). Assessed in preclinical embryo-fetal …