Pharmacokinetics in Renally or Hepatically Impaired Patients

As stated in the guideline, renal impairment is an aging-associated finding that can also occur in younger patients. Therefore, it is a general principle that drugs excreted (parent drug or active metabolites) significantly through renal mechanisms should be studied to define the effects of altered renal function on their pharmacokinetics. Such information is needed for drugs that are the subject of this guideline but it can be obtained in younger subjects with renal impairment.

Similarly, drugs subject to significant hepatic metabolism and/or excretion, or that have active metabolites, may pose special problems in the elderly. Pharmacokinetic studies should be carried out in hepatically impaired young or elderly patient volunteers.

If a Pharmacokinetic Screen approach is chosen by the sponsor, and if patients with documented renal impairment or hepatic impairment (depending on the drug's elimination pattern) are included and the results indicate no medically important pharmacokinetic difference, that information may be sufficient to meet this geriatric guideline's purpose.

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