Use of physiologically based pharmacokinetic models coupled with pharmacodynamic models to assess the clinical relevance of current bioequivalence criteria for generic drug products containing ibuprofen

Journal of Pharmaceutical Sciences

Volumn 103, Issue 10, 2014, Pages 3263-3275

  Cristofoletti, Rodrigo ^a   Dressman, Jennifer B ^b  

^a Agencia Nacional de Vigilancia Sanitaria Brazil   (Brazil)

^b GOETHE UNIVERSITY   (Germany)

Author keywords

Bioequivalence; Biopharmaceutics; Biowaiver; Dissolution; Doseresponse; Ibuprofen; Pharmacokinetic pharmacodynamic models

Indexed keywords

IBUPROFEN; NONSTEROID ANTIINFLAMMATORY AGENT;

ADULT; ANALGESIA; ANTIPYRETIC ACTIVITY; ARTICLE; BIOEQUIVALENCE; CHILD; DISSOLUTION; DOSE RESPONSE; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG DISTRIBUTION; DRUG ELIMINATION; DRUG SOLUBILITY; HUMAN; MOLECULAR WEIGHT; SENSITIVITY ANALYSIS; SMALL INTESTINE; STOMACH EMPTYING; STOMACH PH; THERAPEUTIC EQUIVALENCE; TOOTH PAIN; ADOLESCENT; BIOLOGICAL MODEL; PHARMACOKINETICS; PRESCHOOL CHILD; YOUNG ADULT;

ADOLESCENT; ADULT; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; CHILD; CHILD, PRESCHOOL; HUMANS; IBUPROFEN; MODELS, BIOLOGICAL; PHARMACOKINETICS; THERAPEUTIC EQUIVALENCY; YOUNG ADULT;

EID: 84923333444     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.24076     Document Type: Article

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