TGF ‐β1 monoclonal antibody: Assessment of embryo‐fetal toxicity in rats and rabbits

In conclusion, TGF‐β1 mab produced no adverse maternal or embryo‐fetal findings in rats when administered ≤50 mg/kg on GDs 6, 10, and 14. TGF‐β1 mab did not demonstrate maternal toxicity or embryo‐fetal lethality at doses as high as 30 mg/kg when administered on GDs 7, 12, 14, 16, and 18 in rabbits. Fetal growth and morphology were affected only at 30 mg/kg; thus, the no observed adverse effect level was 3 mg/kg in rabbits. The margin of safety for both rats and rabbits was ≥37‐fold the clinical exposure level.
Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - Category: Perinatology & Neonatology Authors: Tags: Research Article Source Type: research