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... -------------------- FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research. Upcoming Training - https://www.fda.gov/cdersbia SBIA Listserv - https://public.govdelivery.com/accoun... SBIA 2021 Playlist - • 2021 CDER Small Business and Industry Assi... SBIA LinkedIn: / cder-small-business-and-industry-assistance SBIA Training Resources - https://www.fda.gov/cdersbialearn Twitter - / fda_drug_info Email - [email protected] Phone - (301) 796-6707 I (866) 405-5367
Getting to First-in-Human for Small Molecules and Biologics
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Regulatory Considerations for Impurity Qualification: ICH Q3A/Q3C/Q3D, RLD & MDD
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Commissioner’s National Priority Voucher (CNPV) Pilot Program Public Hearing
Nonclinical Safety Assessment for Small Molecules and Biologic Drug Development (6of14) REdI 2018
FDA Direct: Faster Reviews, Food Dye Wins and Protecting American DNA
Introduction to the Drug Master File (DMF) Review Process
