PK/TK data shape critical regulatory and development decisions. When study design misses the mark, exposure profiles fall short, or execution slips, the result is data that creates uncertainty, delays programs, or invites regulatory scrutiny. This session focuses on how to design and execute PK/TK studies that deliver clear, defensible insights when timelines and confidence matter most.
In this presentation we examine practical approaches to dose selection, matrix and timepoint optimization, and executional rigor, all grounded in real-world regulatory expectations. Attendees will leave with concrete strategies to strengthen data integrity, improve interpretability, and reduce downstream risk in early-phase development.
