Adaptive trials in paediatric development: Dealing with heterogeneity and uncertainty in pharmacokinetic differences in children

British Journal of Clinical Pharmacology

Volumn 74, Issue 2, 2012, Pages 346-353

  Cella, Massimo ^a   Danhof, Meindert ^a   Della Pasqua, Oscar ^a,b  

^a LEIDEN UNIVERSITY   (Netherlands)

^b GLAXOSMITHKLINE   (United Kingdom)

Author keywords

Adaptive design; Dose adjustment; Model based drug development; Paediatric drug development; Paediatric drug prescription; Pharmacokinetic bridging

Indexed keywords

ABACAVIR;

ADOLESCENT; AREA UNDER THE CURVE; ARTICLE; CHILD; CHILD DEVELOPMENT; CLINICAL ASSESSMENT; DOSE CALCULATION; DRUG DISTRIBUTION; DRUG DOSE REGIMEN; DRUG EXPOSURE; GENETIC HETEROGENEITY; HUMAN; MAJOR CLINICAL STUDY; PRACTICE GUIDELINE; PRESCHOOL CHILD; PRIORITY JOURNAL; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); SCHOOL CHILD; SIMULATION; STUDY DESIGN;

ADOLESCENT; AGE FACTORS; AGING; AREA UNDER CURVE; CHILD; CHILD, PRESCHOOL; COMPUTER SIMULATION; DIDEOXYNUCLEOSIDES; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG DOSAGE CALCULATIONS; HUMANS; MEDICATION ERRORS; MODELS, BIOLOGICAL; PATIENT SAFETY; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; REVERSE TRANSCRIPTASE INHIBITORS; UNCERTAINTY;

EID: 84863729151     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2012.04187.x     Document Type: Article

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