Clarification on precision criteria to derive sample size when designing pediatric pharmacokinetic studies

Journal of Clinical Pharmacology

Volumn 52, Issue 10, 2012, Pages 1601-1606

  Wang, Yaning ^a   Jadhav, Pravin R ^a   Lala, Mallika ^a   Gobburu, Jogarao V ^a  

^a Center for Drug Evaluation and Research   (United States)

Author keywords

pediatric drug development; pharmacokinetics; precision; regulatory requirement

Indexed keywords

ACCURACY; ARTICLE; CLINICAL TRIAL (TOPIC); DRUG SAFETY; DRUG SCREENING; FEASIBILITY STUDY; HUMAN; SAMPLE SIZE; SAMPLING;

ADOLESCENT; CHILD; CHILD, PRESCHOOL; CLINICAL TRIALS AS TOPIC; HUMANS; INFANT; MODELS, BIOLOGICAL; PHARMACOKINETICS; SAMPLE SIZE;

EID: 84870474781     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270011422812     Document Type: Article

References (9)

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