SAD/MAD Studies definition
SAD/MAD Studies means all single ascending dose (“SAD”) Phase 1 Studies and multiple ascending dose (“MAD”) Phase 1 Studies and, if applicable, associated expansions, where the principal purpose is a further determination of safety and pharmacokinetics of the compound after the initial dose escalation studies. SAD/MAD Studies may include studies aimed at exploring trends of biomarker or clinical endpoint-based dose-efficacy relationship, which are prior to commencement of Phase 2 Studies.