Expansion Cohorts In Clinical Trials Of Oncology Drugs: FDA Issues Guidance
FDA released the final guideline paper in March for first-in-human trial models that include both dosage escalation and various expansion cohorts to assess safety, anti-tumor efficacy, pharmacokinetics (PK), and other features of therapeutic cancer candidates all within a single protocol. The principle is simple: after the optimal Phase 2 dosage has been established during the …
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