Core clinical engineering and protocols for Regulatory In-Silico Acceptance.
Enacted in late 2022, the FDA Modernization Act 2.0 amended the Federal Food, Drug, and Cosmetic Act to allow sponsors to use qualified alternative testing methods—including computational modeling and microphysiological systems—to demonstrate drug safety and efficacy, ending the 1938 mandate for animal testing.
DrugInference formats computational study reports in strict compliance with OECD QSAR principles: defining clear applicability domains, mechanistic rationales, and internal cross-validation metrics, enabling regulatory reviewers to inspect and trust in-silico pharmacological evidence.