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Designing First-In-Human Trials for Small Molecules and Biologics

Martha Donoghue, MD, in the Office of Oncologic Diseases at CDER, discusses key design considerations for first-in-human trials of oncology drugs including, defining patient populations for eligibility, selection of the appropriate starting dose, dose escalation design, minimizing patient risk, dose optimization, and initial assessment of antitumor activity.
Learn more at: https://www.fda.gov/drugs/news-events-human-drugs/oncology-therapy-development-workshop-pivotal-steps-and-avoiding-pitfalls-start-ups-03302021
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