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"P"

pharmacodynamic study
Guideline or reference source
ICHE5(R1) Ethnic factors in the acceptability of foreign clinical data
Definition
A study of a pharmacological or clinical effect of the medicine in individuals to describe the relation of the effect to dose or drug concentration. A pharmacodynamic effect can be a potentially adverse effect (anticholinergic effect with a tricyclic), a measure of activity thought related to clinical benefit (various measures of beta-blockade, effect on ECG intervals, inhibition of ACE or of angiotensin I or II response), a short term desired effect, often a surrogate endpoint (blood pressure, cholesterol), or the ultimate intended clinical benefit (effects on pain, depression, sudden death).
Broader Term
clinical trial
Related Term
pharmacodynamics
 

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