Proton pump inhibitor use in infants: FDA reviewer experience

Journal of Pediatric Gastroenterology and Nutrition

Volumn 54, Issue 1, 2012, Pages 8-14

  Chen, Ii Lun ^a   Gao, Wen Yi ^a   Johnson, Aisha P ^a   Niak, Ali ^a   Troiani, John ^a   Korvick, Joyce ^a   Snow, Nancy ^a   Estes, Kristina ^c   Taylor, Amy ^b   Griebel, Donna ^a  

^a Division of Applied Pharmacology Research   (United States)

^b Office of New Drugs   (United States)

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

Author keywords

Advisory Committee; clinical trials; efficacy; GERD; infants; proton pump inhibitor; safety

Indexed keywords

ESOMEPRAZOLE; LANSOPRAZOLE; OMEPRAZOLE; PANTOPRAZOLE; PLACEBO; PROTON PUMP INHIBITOR;

AREA UNDER THE CURVE; COUGHING; DATA EXTRACTION; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; FEVER; FOOD AND DRUG ADMINISTRATION; GASTROESOPHAGEAL REFLUX; HUMAN; INFANT DISEASE; LARYNGITIS; LONG TERM CARE; MAXIMUM PLASMA CONCENTRATION; OTITIS MEDIA; PATIENT SAFETY; PRIORITY JOURNAL; REVIEW; RHINITIS; SIDE EFFECT; SINGLE DRUG DOSE; UPPER RESPIRATORY TRACT INFECTION;

ADVISORY COMMITTEES; GASTROESOPHAGEAL REFLUX; HUMANS; INFANT; OUTCOME ASSESSMENT (HEALTH CARE); PROTON PUMP INHIBITORS; TREATMENT FAILURE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84855359641     PISSN: 02772116     EISSN: 15364801     Source Type: Journal    
DOI: 10.1097/MPG.0b013e31823890b4     Document Type: Review

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