Studies have shown that the same dose of a pharmaceutical can give a tenfold difference in the levels of active metabolite. In these cases, the given dose leads to a certain number of patients getting an over dose and some not getting enough of the active metabolite. For toxic substances with a small therapeutic window, such as cytostatic, the patient ratio dosed outside of the recommended interval is as high as 50%.
Clinical trial support
We offer our patented method of analyses to companies developing new products, exploring new indications or defining interesting patient groups. In early clinical trial we can help determine the dose interval and in later stages we provide a better understanding of the tox response, and a direct correlation between dose and different patient groups. We also give a better understanding of how the effect is correlated to the active dose, and thus a stronger statistical support for the studies. Monitoring the dose gives a better chance of avoiding undesirable side effects and clearly singles out the patients where the metabolite is presumably to low to provide the desired effect.
We develop tailor made methods with a high sensitivity for all reactive substance that binds covalently to biomarkers. With the help of TailorDose we can monitor how the active dose series on an individual level.