The trials and tribulations of doing drug research in children

CMAJ. Canadian Medical Association Journal

Volumn 169, Issue 10, 2003, Pages 1033-1034

  Matsui, Doreen ^a,b   Kwan, Charisse ^a   Steer, Erin ^a   Rieder, Michael J ^a  

^a UNIVERSITY OF WESTERN ONTARIO   (Canada)

^b CHILDREN S HOSPITAL OF WESTERN ONTARIO   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

BIOAVAILABILITY; COMMUNITY; DRUG RESEARCH; DRUG SCREENING; DRUG USE; INVESTMENT; MEDICAL ASSESSMENT; MEDICAL EDUCATION; MEDICAL ETHICS; MEDICAL INFORMATION; MEDICAL RESEARCH; NOTE; PHYSICIAN; POLICY; QUALITY OF LIFE; RISK FACTOR;

EID: 0344515527     PISSN: 08203946     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Note

References (12)

1. Steinbrook R. Testing medications in children. N Engl J Med 2002;347:1462-70.
2. Moore TJ, Weiss SR, Kaplan S, Blaisdell CJ. Reported adverse drug events in infants and children under 2 years of age. Pediatrics 2002;110:e53.
3. Abi Khaled L, Ahmad F, Brogan T, Fearnley J, Graham J, MacLeod S, et al. Prescription medication use by one million Canadian children. Paediatr Child Health 2003;8(Suppl A):6A-56A.
4. Kwan C, Steer E, Rieder MJ, Matsui D. Barriers to drug investigation in children in Canada: perspectives from academic and community practice. Paediatr Child Health 2002;7(Suppl A):44A.
5. Cohen SN. The Pediatric Pharmacology Research Unit (PPRU) Network and its role in meeting pediatric labeling needs. Pediatrics 1999;104:644-5.
6. Food and Drug Administration Modernization Act of 1997, Public Law 105-115, 105th Congress, 111 Stat 2296 (1997 Nov 21).
7. Department of Health and Human Services, US Food and Drug Administration. The pediatric exclusivity provision: January 2001 status report to Congress. Rockville (MD): The Administration; 2001.
8. Department of Health and Human Services, Food and Drug Administration. Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients; final rule. Federal Register 1998;63 (231):66631-72.
9. US Food and Drug Administration Center for Drug Evaluation and Research. Pediatric drug development. Available: www.fda.gov/cder/pediatric/ (accessed 2003 July 18).
10. Best Pharmaceuticals for Children Act, Public Law 107-109, 107th Congress, 115 Stat 1408 (2002 Jan 4).
11. Conroy S. Unlicensed and off-label drug use: issues and recommendations. Pediatr Drugs 2002;4:353-9.
12. Medical Research Council of Canada, Natural Sciences and Engineering Research Council of Canada and Social Sciences and Humanities Research Council of Canada. Tri-Council policy statement: Ethical conduct for research involving humans. Ottawa: The Councils; 1998.