When to conduct a renal impairment study during drug development: US Food and Drug Administration perspective.
To optimize drug therapy for individuals, it is critical to understand how various intrinsic (e.g., age, gender, race, genetics, organ impairment) and extrinsic factors (e.g., diet, smoking, concomitantly administered drugs) affect drug exposure and response.(1) Up to now, it has been far easier to discover effects on exposure caused by these factors, and the US Food and Drug Administration (FDA) has published several guidance documents with recommendations on how to evaluate these factors during drug development.
Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA. shiewmei.huang@fda.hhs.gov
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D000818:Animals; D015195:Drug Design; D017408:Guidelines as Topic; D006801:Humans; D007674:Kidney Diseases / Q000503:physiopathology*; D004364:Pharmaceutical Preparations / Q000378:metabolism*; D010599:Pharmacokinetics; D012107:Research Design; D014481:United States; D014486:United States Food and Drug Administration
D004364:Pharmaceutical Preparations