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Volumn , Issue , 2006, Pages 25-32

Paediatric drug development - Historical background of regulatory initiatives

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EID: 52449110548     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1159/000097773     Document Type: Chapter
Times cited : (3)

References (18)
  • 2
    • 0033030202 scopus 로고    scopus 로고
    • Status of new medicines approved by the European medi-cines evaluation Agency regarding paediatric use
    • Impicciatore P, Choonara I: Status of new medicines approved by the European Medi-cines Evaluation Agency regarding paediatric use. Br J Clin Pharmacol 1999; 48: 15-18.
    • (1999) Br J Clin Pharmacol , vol.48 , pp. 15-18
    • Impicciatore, P.1    Choonara, I.2
  • 5
    • 0034825508 scopus 로고    scopus 로고
    • Incidence of adverse drug reactions in paediatric in/out patients: a systematic review and meta-analysis of prospective studies
    • Impicciatore P, Choonara I, Clarkson A, Provasi D, Pandolfini C: Incidence of adverse drug reactions in paediatric in/out patients: a systematic review and meta-analysis of prospective studies. Br J Clin Pharmacol 2001; 52: 77-83.
    • (2001) Br J Clin Pharmacol , vol.52 , pp. 77-83
    • Impicciatore, P.1    Choonara, I.2    Clarkson, A.3    Provasi, D.4    Pandolfini, C.5
  • 7
    • 0036352593 scopus 로고    scopus 로고
    • Drug toxicity and adverse drug reactions in children: a brief historical review
    • Choonara I, Rieder MJ: Drug toxicity and adverse drug reactions in children: a brief historical review. Paed Perinatal Drug Ther 2002; 5: 12-18.
    • (2002) Paed Perinatal Drug , vol.5 , pp. 12-18
    • Choonara, I.1    Rieder, M.J.2
  • 8
    • 0020606709 scopus 로고
    • Studies on the efficacy and potential hazards of methylene blue therapy in aniline-induced methaemoglobinaemia
    • Harry JW, Keitt AS: Studies on the efficacy and potential hazards of methylene blue therapy in aniline-induced methaemoglobinaemia. Br J Haematol 1983; 54: 29-41.
    • (1983) Br J Haematol , vol.54 , pp. 29-41
    • Harry, J.W.1    Keitt, A.S.2
  • 9
    • 0023245293 scopus 로고
    • Cyanosis in infants caused by nitrates in well water
    • Comby HH: Cyanosis in infants caused by nitrates in well water. JAMA 1987; 257: 2788-2792.
    • (1987) JAMA , vol.257 , pp. 2788-2792
    • Comby, H.H.1
  • 10
    • 84942481986 scopus 로고
    • Pathologic effects of elixir of sulphanilamide (diethylen glycol) poisoning
    • Geiling EMK, Cannon PR: Pathologic effects of elixir of sulphanilamide (diethylen glycol) poisoning. JAMA 1938; 111: 919-926.
    • (1983) JAMA , vol.111 , pp. 919-926
    • Geiling, E.M.K.1    Cannon, P.R.2
  • 11
    • 0000022275 scopus 로고
    • A difference in mortality rate and incidence of kernicterus among premature infants allotted to two prophylactic antibacterial regimens
    • Silverman WA, et al: A difference in mortality rate and incidence of kernicterus among premature infants allotted to two prophylactic antibacterial regimens. Pediatrics 1956; 18: 614-624.
    • (1956) Pediatrics , vol.18 , pp. 614-624
    • Silverman, W.A.1
  • 14
    • 0026516640 scopus 로고
    • Valproate metabolites in serum and urine during antiepileptic therapy in children with infantile spasms: abnormal me-tabolite pattern associated with reversible hepatotoxicity
    • Fisher E, Siemes H, Pund R, Wittfoht W, Nau H: Valproate metabolites in serum and urine during antiepileptic therapy in children with infantile spasms: abnormal me-tabolite pattern associated with reversible hepatotoxicity. Epilepsia 1992; 33: 165-171.
    • (1992) Epilepsia , vol.33 , pp. 165-171
    • Fisher, E.1    Siemes, H.2    Pund, R.3    Wittfoht, W.4    Nau, H.5
  • 15
    • 0038186605 scopus 로고    scopus 로고
    • American academy of pediatrics: Acetaminophen toxicity in children
    • American Academy of Pediatrics: Acetaminophen toxicity in children. Pediatrics 2001; 108: 1020-1024. http://medicines.mhra.gov.uk/ourwork/monitorsafequalmed/safetymessages/ssrioverview_101203.htm
    • (2001) Pediatrics , vol.108 , pp. 1020-1024
  • 16
    • 5344225688 scopus 로고    scopus 로고
    • Antidepressants and pediatric depression: the risk of doing nothing
    • Brent DA: Antidepressants and pediatric depression: the risk of doing nothing. N Engl J Med 2004; 351: 1598-1601. http://www.fda.gov/cder/pediatric/
    • (2004) N Engl J Med , vol.351 , pp. 1598-1601
    • Brent, D.A.1
  • 18
    • 0036432605 scopus 로고    scopus 로고
    • Lack of effect of the Euro-pean guidance on clinical investigation of medicines in children
    • t'Jong GW, Stricker BHCh, Choonara I, van den Anker JN: Lack of effect of the Euro-pean guidance on clinical investigation of medicines in children. Acta Paediatr 2002; 91: 1233-1238.
    • (2002) Acta Paediatr , vol.91 , pp. 1233-1238
    • t'Jong, G.W.1    Stricker, B.H.C.2    Choonara, I.3    van den Anker, J.N.4


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