Session 1 (June 10th): Modeling and Software Platforms to Support Bioequivalence and Bioavailability
Session 2 (June 11th): PK-Based Bioequivalence Studies
Session 3 (June 12th): In Vitro, Pharmacodynamic, and Clinical Endpoint Bioequivalence Studies
About the Workshop:
This workshop is 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 will be given by his son, Stephen, at the opening of the workshop.
Biostatisticians and scientists from industry and the FDA will present on various topics related to statistical and data analysis issues and solutions for ANDAs and 505(b)(2) NDAs. The workshop will explore 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 is three half-day (morning) virtual sessions with five 20- to 30-minute presentations followed by a panel discussion each day.
The first session (June 10, 2025) will cover the latest developments in modeling methods and software platforms to support BE and BA studies. The speakers for the modeling topics will discuss Emax modeling in vasoconstrictor studies, model-integrated evidence approaches for long-acting injectables, physiologically-based PK (PBPK) modeling, and in vitro – in vivo (IVIVC) correlation model development of immediate-release formulations.
The second session (June 11, 2025) will cover the analysis of data from PK-based BE studies, with a focus on resolving thorny statistical issues that often arise in practice. This session will also address data integrity in BE studies and the efforts to evaluate BE data to detect possible data manipulation and fraudulent activities and discuss the use of generative artificial intelligence to support research and regulatory work in FDA.
The third session (June 12, 2025) will cover the latest statistical and data analysis approaches for BE studies with in vitro, PD and clinical endpoints. The in vitro topics will include the analysis of in vitro permeation testing (IVPT) and equilibrium binding studies, the PD presentation will discuss Locke’s method for analyzing BE data in vasoconstrictor studies per ANVISA and FDA guidances, and the clinical endpoint topics will include a deep dive into the emerging requirements for using estimands in the statistical analysis of clinical endpoint BE study data.