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Volumn 30, Issue 4, 1996, Pages 1149-1162

Strategies for pediatric drug evaluation: A view from the trenches

Author keywords

Children; Clinical trials; Ethical guidelines; Pediatric labeling; Pediatric regulations

Indexed keywords

AMPICILLIN; METHOTREXATE; ORPHAN DRUG; PLACEBO;

EID: 0029827507     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286159603000434     Document Type: Review
Times cited : (7)

References (15)
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    • Morselli et al. (eds). New York: Raven Press
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    • Gilman, J.T.1    Gal, P.2
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    • (1989) Clin Pharmacokinet. , vol.17 , Issue.1 SUPPL. , pp. 29-67
    • Kearns, G.L.1    Reed, M.D.2
  • 6
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    • Children as participants in medical research
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    • (1988) Pediatr Clin North Am. , vol.35 , Issue.6 , pp. 1389-1401
    • Grodin, M.A.1    Alpert, J.J.2
  • 7
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    • Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Populations
    • Committee on Drugs
    • Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Populations, Committee on Drugs. Pediatrics. 1995;95(2):286-294.
    • (1995) Pediatrics , vol.95 , Issue.2 , pp. 286-294
  • 8
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    • Mar 8
    • Additional protection for children involved as subjects in research. Federal Register. Mar 8, 1983; 48:114-117.
    • (1983) Federal Register , vol.48 , pp. 114-117
  • 9
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    • Pharmacokinetic studies in pediatric patients
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    • (1992) Clin Pharmacokinet. , vol.23 , Issue.1 , pp. 10-29
    • Kauffman, R.E.1    Kearns, G.L.2
  • 11
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    • Department of Health and Human Services, Food and Drug Administration 21 CRF Part 201. Specific requirements on content and formal of labeling for human prescription drugs; Revision of "Pediatric Use" Subsection in the Labeling; Final Rule
    • December 13
    • Federal Register, Part II, Department of Health and Human Services, Food and Drug Administration 21 CRF Part 201. Specific requirements on content and formal of labeling for human prescription drugs; Revision of "Pediatric Use" Subsection in the Labeling; Final Rule. December 13, 1994.
    • (1994) Federal Register , Issue.2 PART
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* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.