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On-demand insights: model-informed bioequivalence & biosimilarity

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.

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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

Principal Director, MIDD Scientific Lead

Martin Bergstrand

See bio

Principal Director, PBPK & PBBM Scientific Lead

Erik Sjögren

See bio

Director, System Developer

Henrik Bjugård Nyberg

See bio

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.

Learn more about Model-Informed Bioequivalence & Biosimilarity

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Pharmetheus AB
Kungsängstull 4  
753 19 Uppsala, Sweden

Visiting address:  
Dragarbrunnsgatan 77, 5th floor

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About Pharmetheus

Pharmetheus is a consultancy firm helping clients reduce uncertainty in technical and regulatory processes, increasing confidence in the development of new medicines that can improve patients’ lives.

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