Mechanisms to provide safe and effective drugs for children

Pediatrics

Volumn 134, Issue 2, 2014, Pages

  Laughon, Matthew M ^a   Benjamin Jr , Daniel K ^b  

^a UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

^b DUKE CLINICAL RESEARCH INSTITUTE   (United States)

Author keywords

Clinical trials; Off label drug use; Pediatric exclusivity

Indexed keywords

ANTIINFECTIVE AGENT; ANTINEOPLASTIC AGENT; HORMONE;

CHILD; CHILD HEALTH; CLINICAL PHARMACOLOGY; CLINICAL STUDY; DRUG EFFICACY; DRUG INDUSTRY; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; GOVERNMENT; HUMAN; NOTE; PRIORITY JOURNAL; UNITED STATES;

CLINICAL TRIALS; OFF-LABEL DRUG USE; PEDIATRIC EXCLUSIVITY;

DRUG INDUSTRY; DRUG LABELING; DRUG THERAPY; HUMANS; MARKETING; PATIENT SELECTION; RESEARCH SUBJECTS;

EID: 84905271416     PISSN: 00314005     EISSN: 10984275     Source Type: Journal    
DOI: 10.1542/peds.2014-1585     Document Type: Note

References (3)

1. Wharton GT, Murphy MD, Avant D, et al. Impact of pediatric exclusivity on drug labeling and demonstrations of efficacy. Pediatrics. 2014;134(2). Available at: www.pediatrics.org/cgi/content/full/134/2/e512
2. Benjamin DK Jr, Smith PB, Murphy MD, et al. Peer-reviewed publication of clinical trials completed for pediatric exclusivity. JAMA. 2006;296(10):1266- 1273 (Pubitemid 44394898)
3. Benjamin DK Jr, Smith PB, Jadhav P, et al. Pediatric antihypertensive trial failures: analysis of end points and dose range. Hypertension. 2008;51(4):834-840 (Pubitemid 351654692)