Dose-Finding in Early Development (SAD/MAD, 3+3, CRM, MTD): A Compliance-First Playbook
Dose-Finding in Early Development (SAD/MAD, 3+3, CRM, MTD): A Compliance-First Playbook Engineering First-in-Human and Early Dose Escalation for Safety, Learning, and Regulatory Confidence From Toxicology to First Human Milligram: Starting Dose, Cohorts, and Risk Mitigation Dose-finding begins long before the first participant is screened. Early development translates nonclinical evidence into a human-safe starting point, then…