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Dose ranging studies

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Healthy volunteer Phase I clinical studies can be used to start the process of predicting the optimal dose of a medication before it gets tested in large clinical trials. Single low doses initially will be used moving to multiple dosing with bloods taken for plasma concentrations of drug, and dose–concentration curves plotted. Pharmacodynamic responses to the drug, both desired and side effects, will be noted with the aim of selecting a dose range that will give you the desired effect but with few side effects. This range will then be taken into Phase II trials.

Clinical Pharmacology and Therapeutics

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