31. März 2026
Fähzan Ahmad • 31. März 2026
Why achieving biological relevance starts with selecting the right dose
In vitro studies frequently focus on identifying biological effects without fully considering the physiological relevance of the doses used. While higher concentrations can produce more noticeable effects, they may not reflect what occurs in the body.
Regulatory evaluation requires that dose selection aligns with real-world exposure levels, not just experimental convenience.
The issue with high-dose testing
Using excessively high concentrations in in vitro studies can produce exaggerated effects that don't translate to real biological conditions. These concentrations may induce non-specific stress, toxicity, or artifacts that obscure the true biological response.
An effect at high doses doesn’t always mean relevance at realistic exposure levels.
Why dose matters
Dose determines whether an effect is physiologically significant or merely an artifact of excessive exposure. Appropriate dose selection allows for the identification of meaningful, dose-dependent effects that are consistent with in vivo conditions.
Testing doses must align with achievable concentrations in the body, not just what's easy to test in a lab.
Regulatory perspective
Regulators expect dose-response data that reflects possible in vivo exposure levels. This means selecting doses based on relevant pharmacokinetic parameters (e.g., Cmax) and documenting the full dose-response curve, including thresholds and saturation points.
Without considering realistic doses, results lose predictive value for human application.
Conclusion
The right dose isn’t the highest one—it’s the most relevant one.
A dose too high leads to distortion.
A dose too low misses key effects.
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