When to conduct a renal impairment study during drug development: US food and drug administration perspective

Clinical Pharmacology and Therapeutics

Volumn 86, Issue 5, 2009, Pages 475-479

  Huang, S M ^a   Temple, R ^b   Xiao, S ^b   Zhang, L ^a   Lesko, L J ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b Center for Drug Evaluation and Research   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CREATININE; KETOCONAZOLE; PALIPERIDONE; ROSUVASTATIN; TELBIVUDINE; TELITHROMYCIN;

AREA UNDER THE CURVE; CREATININE BLOOD LEVEL; CREATININE CLEARANCE; DRUG CLEARANCE; DRUG DEVELOPMENT; DRUG RESEARCH; FOOD AND DRUG ADMINISTRATION; GLOMERULUS FILTRATION RATE; HUMAN; KIDNEY FAILURE; KIDNEY FUNCTION; MAXIMUM PLASMA CONCENTRATION; PHARMACODYNAMICS; PHARMACOKINETICS; PRIORITY JOURNAL; RECOMMENDED DRUG DOSE; SHORT SURVEY; UNITED STATES;

ANIMALS; DRUG DESIGN; GUIDELINES AS TOPIC; HUMANS; KIDNEY DISEASES; PHARMACEUTICAL PREPARATIONS; PHARMACOKINETICS; RESEARCH DESIGN; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 70350219254     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2009.190     Document Type: Short Survey

References (15)

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