Researchers studying an overactive bladder treatment have concluded that dose-response models can be used to predict outcomes for doses not studied.
Assessing the dose-response relationship for the antimuscarinic drug fesoterodine wasn't possible using available Phase III trial data because the trials involved only two doses levels. Data on additional doses was required for modeling purposes, so the researchers included stats from earlier-phase trials that studied three doses.
Dose-response data can be obtained directly from clinical trials, the researchers say. They were led by urogynecology professor Linda Cardozo at King's College Hospital in London. However, the study of multiple dosing regimens, which can generate many endpoints, is both costly and problematic. Model-based drug development, by contrast, provides a supplemental means of assessing dosage-increase risk and benefit.
Using the technique, they demonstrated a consistent dose response for fesoterodine in bladder diary endpoints. Their results support the greater efficacy seen with the 8-mg dose found via post hoc analyses of clinical trial data.
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