Simulations Plus Responds To FDA Draft Guidance On Streamlined Nonclinical Safety Studies For Monoclonal Antibodies

Validated engines and AI-orchestrated ecosystem align with the emerging regulatory framework

Simulations Plus, Inc. (NASDAQ:SLP) ("Simulations Plus" or the "Company"), a global leader in model-informed and AI-accelerated drug development that advances biopharma innovation, today responded to the U.S. Food and Drug Administration's draft guidance on streamlined nonclinical safety studies for monospecific monoclonal antibodies. The guidance encourages reduced reliance on animal studies and elevates mechanistic understanding, pharmacokinetics, and integrated weight-of-evidence (WoE) assessments for nonclinical decision-making.