Pharmacokinetic Studies

The guideline states that most of the recognized important differences between younger and older patients have been pharmacokinetic differences, often related to impairment of excretory (renal or hepatic) function or to drug-drug interactions. It is important to determine whether or not the pharmacokinetic behavior of the drug in elderly subjects or patients is different from that in younger adults and to characterize the effects of influences, such as abnormal renal or hepatic function, that are more common in the elderly even though they can occur in any age group. Information regarding age-related differences in the pharmacokinetics of the drug can come, at the sponsor's option, either from a Pharmacokinetic Screen or from formal pharmacokinetic studies, in the elderly and in patients with excretory functional impairment.

The guideline recognizes that for certain drugs and applications (e.g., some topically applied agents, some proteins) technical limitations such as low systemic drug levels may preclude or limit exploration of age-related pharmacokinetic differences.

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