BiLu NOAEL 0.2-3.0 µg/kg (~clinical dose); liver, mammary, spleen, marrow, lymphocyte findings; catumaxomab tolerated 1.5 mg/kg mouse, 0.5 mg/kg rat
“In this study, the no observed adverse effect level (NOAEL) for BiLu is considered to be the low dose (0.2 to 3.0 μg/kg).”
✓ VerifiedEMA assessment report, p. 38Source ↗