volume 86, issue 5, P557-561 2009
DOI: 10.1038/clpt.2009.182
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Abstract: Severe renal impairment can, through diverse mechanisms, alter the pharmacokinetics (PK) of drugs that are renally eliminated and even of some drugs that are nonrenally eliminated. Consequently, dose adjustment for new molecular entities in patients with renal insufficiency is a critical issue in drug development. Clinical pharmacology studies undertaken in patients with renal impairment are generally quite small. We therefore recommend that all pertinent pharmacokinetic data relating to subjects with differen…

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