An Enhanced Pre‐ and Postnatal Development Study in Cynomolgus Monkeys with Tabalumab: A Human IgG4 Monoclonal Antibody

In conclusion, the no‐observed‐adverse‐effect level for maternal and developmental toxicity was 30 mg/kg, the highest dose tested. Exposures at 30 mg/kg provide a margin of safety of 16× the anticipated clinical exposure.

Source: Birth Defects Research Part B: Developmental and Reproductive Toxicology - April 1, 2015 Category: Perinatology & Neonatology Authors: William J. Breslin, Kim G. Hilbish, Jennifer A. Martin, Carolyn A. Halstead, Deanna L. Newcomb, Gary J. Chellman Tags: Research Article Source Type: research