Research article summary (published 30 Oct 2009):

When to conduct a renal impairment study during drug development: US Food and Drug Administration perspective.

Full Abstract

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.

Author information

Author/s: Huang, S-M (SM); Temple, R (R); Xiao, S (S); Zhang, L (L); Lesko, L J (LJ);

Affiliation: 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(-atsign-)fda.hhs.gov

Journal and publication information

Publication Type: Journal Article

Journal: Clinical pharmacology and therapeutics (Clin Pharmacol Ther), published in United States. (Language: eng)

Reference: 2009-Nov; vol 86 (issue 5) : pp 475-9

Dates: Created 2009/10/21; Completed 2009/11/04;

PMID: 19844224, status: MEDLINE (last retrieval date: 11/4/2009, IMS Date: )

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

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MeSH headings (categories)

This article was linked to the MESH Headings shown below.

Animals Drug Design Guidelines as Topic Humans Kidney Diseases - physiopathology

Pharmaceutical Preparations - metabolism Pharmacokinetics Research Design United States United States Food and Drug Administration

Associated Chemicals: Pharmaceutical Preparations (0)

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