This online workshop was held June 10-12, 2025. The event dedicated to the fond memory of two leaders in the world of pharmaceutical statistics, the late Chuck Bon, who was a founding member of SAAMnow, and Sandy Bolton, who together with Chuck co-authored the widely-used book Pharmaceutical Statistics – Practical and Clinical Applications. A tribute to Chuck was given by his son, Stephen, at the opening of the workshop.
Biostatisticians and scientists from industry and the FDA presented on various topics related to statistical and data analysis issues and solutions for ANDAs and 505(b)(2) NDAs. The workshop explored some of the latest methods, research, and regulatory changes addressing how we design and analyze data from bioequivalence (BE) and bioavailability (BA) studies, including in vitro, pharmacokinetic (PK), pharmacodynamic (PD), and clinical endpoint studies. The format of the workshop was three half-day (morning) virtual sessions with five 20- to 30-minute presentations followed by a panel discussion each day.