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The therapeutic index (TI; also referred to as therapeutic ratio) is a quantitative measurement of the relative safety of a drug with regard to risk of overdose. It is a comparison of the amount of a therapeutic agent that causes toxicity to the amount that causes the therapeutic effect. [1] The related terms therapeutic window or safety window ...
Therapeutic drug monitoring (TDM) is a branch of clinical chemistry and clinical pharmacology that specializes in the measurement of medication levels in blood. Its main focus is on drugs with a narrow therapeutic range, i.e. drugs that can easily be under- or overdosed. [ 1 ] TDM aimed at improving patient care by individually adjusting the ...
In pharmacology, potency or biological potency[1] is a measure of a drug's biological activity expressed in terms of the dose required to produce a pharmacological effect of given intensity. [2] A highly potent drug (e.g., fentanyl, clonazepam, risperidone, benperidol, bumetanide) evokes a given response at low concentrations, while a drug of ...
Effective dose (pharmacology) In pharmacology, an effective dose (ED) or effective concentration (EC) is the dose or concentration of a drug that produces a biological response. [1][2] The term "effective dose" is used when measurements are taken in vivo, while "effective concentration" is used when the measurements are taken in vitro. [3]
A dose-ranging study is a clinical trial where different doses of an agent (e.g. a drug) are tested against each other to establish which dose works best and/or is least harmful. Dose-ranging is usually a pre-clinical, phase I or early phase II clinical trial. Typically a dose ranging study will include a placebo group of subjects, and a few ...
In the field of pharmacokinetics, the area under the curve (AUC) is the definite integral of the concentration of a drug in blood plasma as a function of time (this can be done using liquid chromatography–mass spectrometry [ 1 ]). In practice, the drug concentration is measured at certain discrete points in time and the trapezoidal rule is ...
The dose–response relationship, or exposure–response relationship, describes the magnitude of the response of an organism, as a function of exposure (or doses) to a stimulus or stressor (usually a chemical) after a certain exposure time. [1] Dose–response relationships can be described by dose–response curves. This is explained further ...
PK/PD modeling has its importance at each step of the drug development [9] [10] and it has shown its usefulness in many diseases. [11] The Food and Drug Administration also provides guidances for Industry to recommend how exposure-response studies should be performed.