A comparison of the intrasubject variation in drug exposure between generic and brand-name drugs: A retrospective analysis of replicate design trials

British Journal of Clinical Pharmacology

Volumn 81, Issue 4, 2016, Pages 667-678

  Yu, Yang ^a,b   Teerenstra, Steven ^b,c   Neef, Cees ^a   Burger, David ^c   Maliepaard, Marc ^b  

^a MAASTRICHT UNIVERSITY   (Netherlands)

^b MEDICINES EVALUATION BOARD   (Netherlands)

^c RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

Author keywords

bioequivalence study; generic drugs; intrasubject variability

Indexed keywords

ALENDRONIC ACID; ATORVASTATIN; CYCLOSPORIN; EBASTINE; EXEMESTANE; MYCOPHENOLATE MOFETIL; ROPINIROLE; GENERIC DRUG;

AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; DRUG EXPOSURE; DRUG FORMULATION; HUMAN; MAXIMUM PLASMA CONCENTRATION; PRIORITY JOURNAL; RETROSPECTIVE STUDY; STUDY DESIGN; BIOLOGICAL MODEL; CLASSIFICATION; CLINICAL TRIAL (TOPIC); DOSE RESPONSE; THERAPEUTIC EQUIVALENCE; TIME FACTOR;

AREA UNDER CURVE; CLINICAL TRIALS AS TOPIC; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUGS, GENERIC; HUMANS; MODELS, BIOLOGICAL; PATIENT-SPECIFIC MODELING; RETROSPECTIVE STUDIES; THERAPEUTIC EQUIVALENCY; TIME FACTORS;

EID: 84961880187     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/bcp.12828     Document Type: Article

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