A major aspect of clinical trials is the determination of a dosing regimen that will be effective and reasonably safe. The author presents a brief overview of the major considerations that govern the choice of dosage regimens for clinical trials and dosage recommendations for the labeling of marketed products. They include: (1) determination of the lowest effective dose, (2) determination of a safe dose for patients with liver or renal disease, (3) recommendations for doses in the elderly, (4) determination of the effect of concomitant drugs on drug disposition, and (5) examination of dose proportionality. Association of blood levels with desired therapeutic effect also is discussed.
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