On-demand insights: model-informed bioequivalence & biosimilarity
Model-informed strategies are no longer optional - they are the key to de-risking and accelerating bioequivalence & biosimilarity success.
This webinar series provides an introduction to model-informed bioequivalence, including its potential and limitations. You’ll gain an understanding of the techniques physiologically-based biopharmaceutics modeling (PBBM) for virtual bioequivalence and non-linear mixed-effects modeling (NLME) for model-based bioequivalence (MBBE), and how they are transforming approaches to drug development and regulatory submissions.
Topics
Introduction to Model-Informed Bioequivalence and Biosimilarity
Martin Bergstrand
Physiologically Based Modeling for Virtual Bioequivalence
Erik Sjögren
Model-Based Bioequivalence with Non-Linear Mixed-Effects Modeling
Henrik Bjugård Nyberg
Target audience
The methodologies discussed are particularly relevant for project leaders, pharmacokineticists, clinical pharmacologists, formulation scientists, biostatisticians, and professionals in regulatory affairs.
The content is not just theoretical, but directly applicable to professionals specializing in generic drugs and biosimilars. It leverages modeling and simulation to de-risk and accelerate key steps in the development process, from defining relevant quality criteria to model-based approaches for establishing bioequivalence/biosimilarity, providing practical solutions for professionals in the field.
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Related service
Model-Informed Bioequivalence & Biosimilarity services
Our model-informed strategies reduce development risk, meet evolving regulatory standards, support biowaiver approaches, and offer robust, validated alternatives to traditional non-compartmental analysis (NCA) methods.