Proposals for model-based paediatric medicinal development within the current European Union regulatory framework

British Journal of Clinical Pharmacology

Volumn 68, Issue 4, 2009, Pages 493-501

  Manolis, Efthymios ^a   Pons, Gérard ^b  

^a EUROPEAN MEDICINES AGENCY   (United Kingdom)

^b HÔPITAL SAINT VINCENT DE PAUL   (France)

Author keywords

Modelling and simulation; Paediatric drug development; Regulatory science

Indexed keywords

NEW DRUG;

ALGORITHM; CHILD; DATA ANALYSIS; DRUG RESEARCH; EUROPEAN UNION; HUMAN; MODEL; PRACTICE GUIDELINE; PREDICTION; PRIORITY JOURNAL; REVIEW; SIMULATION;

CHEMISTRY, PHARMACEUTICAL; CHILD; CHILD, PRESCHOOL; DRUG EVALUATION; EUROPEAN UNION; HUMANS; LEGISLATION, DRUG; MODELS, CHEMICAL; PEDIATRICS;

EID: 70449105165     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2009.03484.x     Document Type: Review

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