Monitoring the active dose

Everybody deserves to be treated differently

Analyzing the active drug dose

The standard dose regimen today is based on three pillars: flat dosing, where everybody gets the same dose; dose based on weight; and dose based on body surface area (BSA). This allows for a certain degree of dose personalization. What is not accounted for is the plethora of factors that determines how an individual metabolizes and clears the given substance. These factors give a high inter individual variance and determines how much of the active metabolite each patient is exposed to. Individuals receiving the same dose can have several hundred percent difference in exposure. In consequence some patients end up well over the recommended dose interval and some ends up below. In patients undergoing cytostatic treatment the number outside the recommended dose span has been estimated to exceed 50%.

By analyzing the active dose after pharmaceutical administration it is possible to assess each individual’s response to the dose and monitor the patients that falls out of the desired dose range.

Active dose adjustment

Monitoring the active dose can serve several purposes, especially if the measurement is followed by dose adjustments.

During late state clinical trials, the statistical base can be made smaller without compromising with clinical value. Knowing that all participants receives the approved dose makes efficacy easier to assess, shows a better tox profile and reduces the time and money spent on sample collection. The heightened insight into the correlation between dose and effect can also improve statistics and single out groups with discrepant genetic or metabolic behaviors.

By using dose monitoring as a companion diagnostic the treatments will have a higher efficacy and safety. In other words, the best possible care is given.

Benefits

(I)   Patients being wrongly dosed can be eliminated by reanalyzing samples from already closed trials, the statistics can be improved, optimal AUC level can be identified.

(II)   The number of patients, when being actively dose-adjusted with TailorDose®, can be much smaller than today to demonstrate the clinical value, especially valuable at late stages in clinical trials.

(III)  The benefits by using the technology as a companion diagnostic will result in higher efficacy and higher safety. Patients will live longer and stay healthier. Highly valuable for the whole health care system, for society at large, for pharma companies (longer sales periods per patient to a higher price) and especially for the patient and near relatives at both the private and professional level.

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