Succeeding Bioequivalence

Succeeding Bioequivalence

Achieving Bioequivalence Is No Longer a Matter of Chance

Succeeding in bioequivalence (BE) studies is no longer a gamble. With sound scientific understanding and a robust development strategy, passing BE can become a predictable and achievable outcome.

Backed by a proven track record of over 300 successful BE studies, our expertise lies in offering comprehensive solutions that minimize uncertainties and maximize your chances of success. We achieve this through a three-pronged orthogonal approach:

In-Vitro Strategy

Going beyond conventional comparative dissolution profiles (CDP), our in-vitro strategy delves deep into the micro-level understanding of physicochemical properties and in-vitro similarities. This includes:

Advanced reverse engineering
PK-relevant dissolution method design
Detailed physicochemical profiling

This enables formulation teams to better predict in-vivo behavior and align with regulatory expectations.

In-Silico Strategy

Leveraging cutting-edge PBPK modeling and AI-based tools, we help develop optimized formulations or evaluate the BE success potential of existing ones. Key aspects include:

Predictive modeling for formulation development
BE success probability estimation
Assessment of possibilities for BE waivers

We have an exclusive partnership with InSilicominds in Malaysia, providing access to advanced modeling solutions that support decision-making and regulatory strategy.

In-Vivo Strategy

Our in-vivo expertise focuses on the strategic execution of BE studies, including:

Selection of the most suitable CRO based on molecule-specific requirements
Designing optimized study protocols (study design, subject numbers, diet considerations)
Real-time monitoring, statistical planning, and regulatory-compliant report preparation

Succeeding Bioequivalence

Succeeding Bioequivalence

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