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stat.AP2026
Regulatory Expectations for Bayesian Methods in Drug and Biologic Clinical Trials: A Practical Perspective on FDA's 2026 Draft Guidance
Yuan Ji, Ph. D
The U.S. Food and Drug Administration (FDA) released a landmark draft guidance in January 2026 on the use of Bayesian methodology to support primary inference in clinical trials of…
stat.AP2026★ 1 cited
Precision Dose-Finding Design for Phase I Oncology Trials by Integrating Pharmacology Data
Kyong Ju Lee, Yuan Ji
Phase I oncology trials aim to identify a safe dose - often the maximum tolerated dose (MTD) - for subsequent studies. Conventional designs focus on population-level toxicity model…