Webinar on Model-Informed Bioequivalence & Biosimilarity

In the rapidly evolving landscape of drug development, demonstrating bioequivalence is a critical step for bringing generic drugs and biosimilars to market. It also plays a significant role in novel drug development, bridging the gap between clinical data from different formulations or manufacturing sites.

The traditional approach, relying heavily on clinical studies, can be resource-intensive and time-consuming. But what if we could use advanced modeling and simulation to streamline this process, making it faster, more efficient, and more cost-effective?

This webinar 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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If you are interested in a similar lecture for your organization, or wish to access the on-demand recording of this webinar, please contact us at marketing@pharmetheus.com

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

Pharmetheus services

Marylore Chenel

Chaired by

Martina Lundberg

There will be time for Q&A during the webinar where Pharmetheus Scientific Advisors: Prof. Andrew Hooker and Regulatory Affairs Senior Consultant Dr. Emma Hansson also will be available to answer participant questions. 

This event has passed.

Date & time: October 14, 15.30-17.00 (GMT+2)
Format: Online webinar
Fee: Free

This webinar, led by experts in the field, is designed for scientists and strategic leaders in pharmaceutical development. It is tailored specifically for novel drug developers who require robust strategies for bridging clinical data across different formulations, manufacturing processes, or for line extensions. The session will demonstrate how model-based approaches can be used to facilitate a range of related development steps.

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.

The methodologies discussed are particularly relevant for your roles as project leaders, pharmacokineticists, clinical pharmacologists, formulation scientists, biostatisticians, and professionals in regulatory affairs. This webinar is designed to provide you with the tools and knowledge you need to excel in your field.