Statistical Considerations When Planning Phase I Clinical Trials in Oncology – From the Safety Perspective — PMDA Early Consideration Summary
Points to Consider for the Evaluation of the Effects of Food on the Pharmacokinetics of Oral Drug Products — PMDA Early Consideration Summary
Points to Consider for Clinical Evaluation of Drug-Drug Interactions using Endogenous Biomarker — PMDA Early Consideration Summary
Handling of Japanese Data for Confirmation of Comparability of Biosimilars to the Original Biopharmaceuticals — PMDA Early Consideration Summary
Considerations for Determining the Necessity of Comparative Efficacy Studies in Demonstrating Biosimilarity between Biosimilars and Reference Products — PMDA Early Consideration Summary