Bioequivalence is one of the most important disciplines in modern drug development especially where generic and complex-generic products play a critical role in expanding patient access to medicines. As formulations grow more complex and trial populations more diverse, the field is moving beyond traditional non-compartmental approaches toward model-based bioequivalence (MBBE), which uses population PK and mechanistic modeling to enable smaller studies, more flexible designs, and stronger inference.

PumasAI is proud to support this transition with two of the leading tools in the space, Pumas, our comprehensive platform for nonlinear mixed-effects modeling and clinical pharmacology, and PumasCP, a GUI purpose-built for modern bioequivalence workflows. Together, they help research and regulatory teams run smarter studies, strengthen their submissions, and accelerate the path from formulation to patient.

Date: November 1 - 6, 2026

Location: Campus San Joaquín, Pontificia Universidad, Católica de Chile.

Sponsor Talk

Date: November 6, 2026 | 11:00 am - 12:30 pm

Speaker: Mélanie Wilbaux, PhD

Topic: Model-Informed Bioequivalence When Conventional Studies Fall Short: From Concept to Regulatory Practice

The talk will introduce model-informed bioequivalence, an approach that pairs validated population PK models with clinical-trial simulation to demonstrate bioequivalence where a standard study is impractical. It will then walk through two real-world programs. The first is a long-acting injectable for HIV, where half-lives of months make full follow-up impractical. The second is a biosimilar for a rare pediatric leukemia, where small patient numbers leave conventional studies underpowered. A single question will run through both: what makes model-based evidence credible enough for a regulator to act on. Together, they will offer a practical look at how pharmacometrics is accelerating the path from development to approval.

Workshop

Date: November 2, 2026 | 8:30 am - 5:30 pm

Instructors: Mike Tagen, PhD, Lucas Pereira

Topic: Model-Informed Bioequivalence (MIBE) using Pumas

Model-based bioequivalence (MBBE) is a key tool in generic drug development. This workshop will provide both an overview of MBBE and hands-on experience with several case studies using Pumas software. Examples include BE for a pediatric drug using adult BE data, reference-scaled average BE of highly variable oral drugs, narrow therapeutic index drugs, and long-acting injectables.

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