Rationale and conditions for the requirement of chiral bioanalytical methods in bioequivalence studies

European Journal of Clinical Pharmacology

Volumn 66, Issue 6, 2010, Pages 599-604

  Torrado, Juan José ^a   Blanco, María ^a   Farré, Magí ^b,c   Roset, Pere ^d   García Arieta, Alfredo ^e  

^a UNIVERSIDAD COMPLUTENSE DE MADRID   (Spain)

^b HOSPITAL DEL MAR   (Spain)

^c UNIVERSITAT AUTÒNOMA DE BARCELONA   (Spain)

^d Centro de Investigaciones Farmaceuticos Grupo Ferrer   (Spain)

^e Department of Human Use Medicines   (Spain)

Author keywords

Bioequivalence; Chirality; Enantiomers; Ibuprofen; Regulatory requirements

Indexed keywords

IBUPROFEN; NONSTEROID ANTIINFLAMMATORY AGENT;

ANALYTIC METHOD; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CHIRAL BIOANALYTICAL METHOD; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; ENANTIOMER; FEMALE; HUMAN; HUMAN EXPERIMENT; MALE; MAXIMUM PLASMA CONCENTRATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; SUSPENSION; TIME TO MAXIMUM PLASMA CONCENTRATION; ANALYSIS OF VARIANCE; BIOASSAY; BLOOD; CHEMICAL MODEL; CROSSOVER PROCEDURE; INTESTINE ABSORPTION; METHODOLOGY; ORAL DRUG ADMINISTRATION; PHARMACOKINETICS; STEREOISOMERISM;

ADMINISTRATION, ORAL; ANALYSIS OF VARIANCE; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; AREA UNDER CURVE; BIOLOGICAL ASSAY; CROSS-OVER STUDIES; HUMANS; IBUPROFEN; INTESTINAL ABSORPTION; MODELS, CHEMICAL; STEREOISOMERISM; THERAPEUTIC EQUIVALENCY;

EID: 77954915706     PISSN: 00316970     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00228-010-0792-7     Document Type: Article

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