S8: Immunotoxicity Studies For Human Pharmaceuticals

Description - Figure 1: Flow Diagram for Recommended Immunotoxicity Evaluation

All human pharmaceuticals (non-biologicals). (2.1) identify factors to consider. (2.2) weight of evidence (WoE) review. WoE review warrants additional immunotoxicity testing? No. Additional nonclinical immunotoxicity testing not needed. Yes. (3.0) conduct additional immunotoxicity studies. (3.4) significant changes observed? No. (3.4 Pt1) further nonclinical immunotoxicity testing not needed. Yes. (3.4) sufficient data for risk assessment/risk management? Yes. (3.4 Pt 3) further nonclinical immunotoxicity testing not needed. No. (3.4 Pt 2) consider further immunotoxicity testing.