Replicate study design in bioequivalency assessment, pros and cons: bioavailabilities of the antidiabetic drugs pioglitazone and glimepiride present in a fixed-dose combination formulation

Journal of Clinical Pharmacology

Volumn 47, Issue 7, 2007, Pages 806-816

  Karim, Aziz ^a   Zhao, Zhen ^a   Slater, Margaret ^a   Bradford, Dawn ^a   Schuster, Jennifer ^a   Laurent, Aziz ^b  

^a Takeda Global Research   (United States)

^b Pharmaceutical Product Development   (United States)

Author keywords

Bioequivalency; Fixed dose combination; Glimepiride; Intersubject and intrasubject systemic exposure variability; Oral antidiabetics; Pioglitazone; Replicate study design

Indexed keywords

GLIMEPIRIDE; PIOGLITAZONE; 2,4 THIAZOLIDINEDIONE DERIVATIVE; ANTIDIABETIC AGENT; SULFONYLUREA DERIVATIVE;

ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CONTROLLED STUDY; DIZZINESS; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CONCENTRATION; DRUG FATALITY; DRUG FORMULATION; DRUG METABOLISM; FEMALE; HEADACHE; HUMAN; HUMAN EXPERIMENT; MALE; NAUSEA; SEX DIFFERENCE; SINGLE DRUG DOSE; TREMOR; ADOLESCENT; BIOAVAILABILITY; BLOOD; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CROSSOVER PROCEDURE; DRUG COMBINATION; MIDDLE AGED; PHARMACOKINETICS; RANDOMIZED CONTROLLED TRIAL;

ADOLESCENT; ADULT; AREA UNDER CURVE; BIOLOGICAL AVAILABILITY; CROSS-OVER STUDIES; DRUG COMBINATIONS; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; HYPOGLYCEMIC AGENTS; MALE; MIDDLE AGED; SEX FACTORS; SULFONYLUREA COMPOUNDS; THERAPEUTIC EQUIVALENCY; THIAZOLIDINEDIONES;

EID: 34548045534     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270007300954     Document Type: Article

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