Same drug, different dosing: Differences in dosing for drugs approved in the United States, Europe, and Japan

Journal of Clinical Pharmacology

Volumn 48, Issue 8, 2008, Pages 900-908

  Malinowski, Henry J ^a,d   Westelinck, Agnes ^c   Sato, Junko ^b   Ong, Ting ^a  

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

^b PHARMACEUTICALS AND MEDICAL DEVICES AGENCY   (Japan)

^c HOFFMANN LA ROCHE INC   (United States)

^d NONE   (United States)

Author keywords

Dosing; Drug safety; Exposure response; International; Regulatory decisions

Indexed keywords

AMLODIPINE; AMOXICILLIN PLUS CLAVULANIC ACID; BENAZEPRIL; CANDESARTAN; CEFDINIR; CEFUROXIME; CIPROFLOXACIN; CISAPRIDE; CLARITHROMYCIN; DICLOFENAC; DILTIAZEM; DOXAZOSIN; ENALAPRIL; FLUCONAZOLE; ITRACONAZOLE; KETOPROFEN; LANSOPRAZOLE; LEVOFLOXACIN; LISINOPRIL; LOSARTAN; METOPROLOL; NABUMETONE; NIFEDIPINE; OMEPRAZOLE; PERINDOPRIL; QUINAPRIL; SOTALOL; TERBINAFINE; UNINDEXED DRUG; VALSARTAN;

ARTICLE; DRUG DOSE REGIMEN; DRUG INDICATION; DRUG INDUSTRY; DRUG LABELING; DRUG SAFETY; EUROPE; HUMAN; JAPAN; PRESCRIPTION; SUSTAINED RELEASE FORMULATION; UNITED STATES;

DATA COLLECTION; DRUG THERAPY; EUROPEAN UNION; FLUOROBENZENES; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; JAPAN; PHARMACEUTICAL PREPARATIONS; PYRIMIDINES; SULFONAMIDES; UNITED STATES;

EID: 47549096607     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270008319794     Document Type: Article

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