What does it take for a generic drug to be considered just as effective as its brand-name counterpart? The answer lies in Bioequivalence.

BE ensures that a generic drug performs in the same manner as its brand-name counterpart. It is defined as the absence of a significant difference in the rate and extent to which the active ingredient becomes available at the site of action when administered under similar conditions. Establishing BE is critical for demonstrating therapeutic equivalence, supporting Abbreviated New Drug Applications (ANDAs), and ultimately ensuring patient safety and treatment efficacy.

In collaboration with the Society of Pharmacometrics and Health Analytics (SOPHAS), we are excited to announce our upcoming course: Bioequivalence Analysis in Drug Development.

Designed for professionals, students, and researchers eager to deepen their understanding of BE study design, regulatory requirements, statistical methodologies, and real-world applications, this course provides you with the skills to design, analyze, and interpret bioequivalence studies, helping you master essential statistical tools for effective drug development.

Details

🗓️ Duration: August–October 2025

📖 Mode: Flipped-classroom

💼Instructors:

Dr. Yoni Nazarathy, Expert Statistical Consultant, PumasAI

Dr. Vijay Ivaturi, CEO, PumasAI

Let’s shape a future where bioequivalence science drives safer, more accessible, and regulatory-aligned therapeutics—built on readiness, precision, and innovation.

Click here to read more and register.