Feasibility of biowaiver extension to Biopharmaceutics Classification System Class III drug products: Cimetidine

Clinical Pharmacokinetics

Volumn 45, Issue 4, 2006, Pages 385-399

  Jantratid, Ekarat ^a,b   Prakongpan, Sompol ^b   Amidon, Gordon L ^c   Dressman, Jennifer B ^a  

^a GOETHE UNIVERSITY   (Germany)

^b MAHIDOL UNIVERSITY   (Thailand)

^c UNIVERSITY OF MICHIGAN   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AEROSIL; CIMEHEXAL; CIMETIDINE; CIMULCER; DURA H2; EUDRAGIT; POLYMETHACRYLIC ACID; RANITIDINE; SIAMIDINE; ULSAMET;

AREA UNDER THE CURVE; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORRELATION ANALYSIS; DISSOLUTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG FORMULATION; DRUG MANUFACTURE; DUODENUM ULCER; FEASIBILITY STUDY; FOOD AND DRUG ADMINISTRATION; HUMAN; MALE; MEAN RESIDENCE TIME; NORMAL HUMAN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; STOMACH ULCER; TABLET COMPRESSION;

ADULT; BIOLOGICAL AVAILABILITY; BIOPHARMACEUTICS; CIMETIDINE; DRUG APPROVAL; EXCIPIENTS; HUMANS; INTESTINAL ABSORPTION; MALE; PERMEABILITY; POLYMETHACRYLIC ACIDS; SOLUBILITY; TABLETS; THERAPEUTIC EQUIVALENCY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 33645503065     PISSN: 03125963     EISSN: 03125963     Source Type: Journal    
DOI: 10.2165/00003088-200645040-00004     Document Type: Article

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