Appropriate Dose Selection — How to Optimize Clinical Drug by T. Singer (auth.), J. Venitz, W. Sittner (eds.)

By T. Singer (auth.), J. Venitz, W. Sittner (eds.)

Optimal dose individualization has develop into extra vital in enhancing scientific efficacy and defense, given the variety in drug reaction, e.g., because of concurrent health problems or co-medications. for that reason, the position of optimum dose discovering in early scientific drug improvement on the way to maximize profitable scientific use is emphasised. the continuing use of biomarkers – in response to the (known) pharmacology of the drug and/or biology of the underlying ailment – besides exposure–response evaluate all through all stages of drug improvement can quantitatively combine medical pharmacology wisdom, offer early evidence of suggestion, and assist in rational dose choice and rational drug product labeling for medical use.

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Biomarker in preclinical development (pharmacology) Aim To identify pharmacological activity Example Association of blood pressure-lowering effect in suitable animal models with likelihood of having the intended therapeutic activity in patients C. Biomarker in preclinical development (pharmacokinetics) Aim To guide dose selection and dose escalation strategies and to prevent adverse events Example Association between blood levels and desired and undesired effects; PK/PD modeling D. 6 Examples for Using Biomarkers in Early Clinical Development A biomarker or surrogate marker is likely to be of greatest use if the therapeutic effect is difficult to measure, if there is a long delay between drug exposure and effect, if the novel drug acts on a pathway for which the role in disease is not well understood, or in conditions such as stroke, where large groups’ sites may be required to demonstrate efficacy (Rolan et al.

Classification of biomarkers (based on “directness”) Biochemical or other measures of drug action at the molecular target level Physiological measures Pathological assessments Clinical ratings Table 2. Classification of biomarkers (based on mechanism of action) Binding to the drug target (level 1) Activation of the target (level 2) Clinical response (level 3) Table 3. New classification of biomarkers (Danhof et al. , degree of binding to a receptor or inhibition of an agonist). 3 Why Do We Need Biomarkers?

The safety margin provided by microdosing offers the possibility of conducting FIH studies with anti-cancer agents in healthy volunteers. The reliable and rapid recruitment of these subjects at specialized centers offers far more rapid generation of data to address issues related to PK and metabolism. , in the selection of the starting dose and the escalation plan, thus improving the efficiency of the study in terms of the proportion of patients receiving an efficacious dose and of the time required to reach the study’s endpoints.

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