Leveraging prior quantitative knowledge in guiding pediatric drug development: A case study

Pharmaceutical Statistics

Volumn 8, Issue 3, 2009, Pages 216-224

  Jadhav, Pravin R ^a   Zhang, Jialu ^a   Gobburu, Jogarao V S ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

BPCA; Clinical trial simulations; Exclusivity; FDAAA; Pediatrics; Power; PREA; Trial design

Indexed keywords

FENOLDOPAM MESILATE; PLACEBO;

ADULT; AGE DISTRIBUTION; ARTICLE; BLOOD PRESSURE REGULATION; CASE STUDY; CHILD; CLINICAL STUDY; CONTROLLED STUDY; DRUG DESIGN; DRUG DOSE REGIMEN; DRUG DOSE TITRATION; DRUG MEGADOSE; DRUG RESEARCH; DRUG SENSITIVITY; FOOD AND DRUG ADMINISTRATION; HUMAN; LOW DRUG DOSE; PEDIATRICS; POPULATION RESEARCH; QUANTITATIVE STUDY; SAMPLE SIZE; STATISTICAL MODEL;

CHILD; CLINICAL TRIALS AS TOPIC; DRUG DISCOVERY; EVALUATION STUDIES AS TOPIC; HUMANS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 73349143952     PISSN: 15391604     EISSN: 15391612     Source Type: Journal    
DOI: 10.1002/pst.394     Document Type: Article

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