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Volumn 49, Issue 2, 2000, Pages 93-97

Drug trials in children: Problems and the way forward

Author keywords

Clinical trials; Licensed; Medicines in children; Off label; Paediatric drug therapy; Unlicensed

Indexed keywords

BLOOD SAMPLING; CHILD; DRUG FORMULATION; DRUG INDUSTRY; DRUG SCREENING; DRUG TOXICITY; ETHICS; PRIORITY JOURNAL; SHORT SURVEY;

EID: 0033984630     PISSN: 03065251     EISSN: None     Source Type: Journal    
DOI: 10.1046/j.1365-2125.2000.00125.x     Document Type: Short Survey
Times cited : (85)

References (35)
  • 1
    • 0004070976 scopus 로고    scopus 로고
    • London. British Paediatric Association, May
    • 1 Licensing medicines for children. London. British Paediatric Association, May 1996.
    • (1996) Licensing Medicines for Children
  • 2
    • 0030043616 scopus 로고    scopus 로고
    • Use of 'off-label' and unlicensed drugs in paediatric intensive care unit
    • 2 Turner S, Gill A, Nunn T, Choonara I, Hewitt B. Use of 'off-label' and unlicensed drugs in paediatric intensive care unit. Lancet 1996; 347: 549-550.
    • (1996) Lancet , vol.347 , pp. 549-550
    • Turner, S.1    Gill, A.2    Nunn, T.3    Choonara, I.4    Hewitt, B.5
  • 6
    • 0029163420 scopus 로고
    • Lorazepam versus diazepam in the acute treatment of epileptic seizures and status cpilepticus
    • 6 Appleton R, Sweency A, Choonara I, Robson J, Molyneux E. Lorazepam versus diazepam in the acute treatment of epileptic seizures and status cpilepticus. Dev Med Child Neurol 1995; 37: 682-688.
    • (1995) Dev Med Child Neurol , vol.37 , pp. 682-688
    • Appleton, R.1    Sweency, A.2    Choonara, I.3    Robson, J.4    Molyneux, E.5
  • 7
    • 0028046595 scopus 로고
    • A prospective study of the adverse effects of midazolam on withdrawal in critically ill children
    • 7 Hughes J. Gill A, Leach HJ, et al. A prospective study of the adverse effects of midazolam on withdrawal in critically ill children. Acta Paediatr 1994; 83: 1194-1199.
    • (1994) Acta Paediatr , vol.83 , pp. 1194-1199
    • Hughes, J.1    Gill, A.2    Leach, H.J.3
  • 9
    • 0031863681 scopus 로고    scopus 로고
    • Licensing of medicines
    • 9 Choonara I, Dunne J. Licensing of medicines. Arch Dis Child 1998; 78: 402-403.
    • (1998) Arch Dis Child , vol.78 , pp. 402-403
    • Choonara, I.1    Dunne, J.2
  • 10
    • 0032986946 scopus 로고    scopus 로고
    • Paediatric prescribing: Using unlicensed drugs and medicines outside their licensed indications
    • 10 Collier J. Paediatric prescribing: using unlicensed drugs and medicines outside their licensed indications. Br J Clin Pharmacol 1999; 48: 5-8.
    • (1999) Br J Clin Pharmacol , vol.48 , pp. 5-8
    • Collier, J.1
  • 11
    • 0033030202 scopus 로고    scopus 로고
    • Status of new medicines approved by the European Medicines Evaluation Agency regarding paediatric use
    • 11 Impicciatore P, Choonara I. Status of new medicines approved by the European Medicines 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
  • 14
    • 0028577492 scopus 로고
    • Population pharmacokinetics of midazolam in neonates
    • 14 Burtin P, Jacqz-Aigrain E, Girard P, et al. Population pharmacokinetics of midazolam in neonates. Clin Pharmacol Ther 1994; 56: 615-625.
    • (1994) Clin Pharmacol Ther , vol.56 , pp. 615-625
    • Burtin, P.1    Jacqz-Aigrain, E.2    Girard, P.3
  • 15
    • 4243236395 scopus 로고    scopus 로고
    • Morphine and morphine-6-glucuronide in the plasma and cerebrospinal Quid of children
    • 15 Hain RDW, Hardcastle A, Pinkerton CR, Aheme GW. Morphine and morphine-6-glucuronide in the plasma and cerebrospinal Quid of children. Arch Dis Child 1999; 80(Suppl 1): A9.
    • (1999) Arch Dis Child , vol.80 , Issue.SUPPL. 1
    • Hain, R.D.W.1    Hardcastle, A.2    Pinkerton, C.R.3    Aheme, G.W.4
  • 16
    • 0030025176 scopus 로고    scopus 로고
    • Steady state plasma concentrations of midazolam in critically ill infants and children
    • 16 Hughes J, Gill AM, Mulhearn H, Powell H, Choonara I. Steady state plasma concentrations of midazolam in critically ill infants and children. Ann Pharmacother 1996; 30: 27-30.
    • (1996) Ann Pharmacother , vol.30 , pp. 27-30
    • Hughes, J.1    Gill, A.M.2    Mulhearn, H.3    Powell, H.4    Choonara, I.5
  • 17
    • 0029931224 scopus 로고    scopus 로고
    • Morphine, morphine-6-glucuronide and morphine-3-glucuronide pharmacokinetics in newborn infants receiving diamorphine infusions
    • 17 Barrett DA, Barker DP, Rutter N, Pawula M, Shaw PN. Morphine, morphine-6-glucuronide and morphine-3-glucuronide pharmacokinetics in newborn infants receiving diamorphine infusions. Br J Clin Pharmacol 1996; 41: 531-537.
    • (1996) Br J Clin Pharmacol , vol.41 , pp. 531-537
    • Barrett, D.A.1    Barker, D.P.2    Rutter, N.3    Pawula, M.4    Shaw, P.N.5
  • 18
    • 0029839445 scopus 로고    scopus 로고
    • Drug toxicity and surveillance in children
    • 18 Choonara I, Gill A, Nunn A. Drug toxicity and surveillance in children. Br J Clin Pharmacol 1996; 42: 407-410.
    • (1996) Br J Clin Pharmacol , vol.42 , pp. 407-410
    • Choonara, I.1    Gill, A.2    Nunn, A.3
  • 19
    • 0026516640 scopus 로고
    • Valproate metabolites in serum and urine during antiepileptic therapy in children with infantile spasms; abnormal metabolite pattern associated with reversible hepatotoxicity
    • 19 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 metabolite 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
  • 20
  • 21
    • 0025826953 scopus 로고
    • Paracetamol poisoning in children and hcpatotoxicity
    • 21 Penna A, Buchanan N. Paracetamol poisoning in children and hcpatotoxicity. Br J Clin Pharmacol 1991; 32: 143-149.
    • (1991) Br J Clin Pharmacol , vol.32 , pp. 143-149
    • Penna, A.1    Buchanan, N.2
  • 22
    • 0024535104 scopus 로고
    • Urinary excretion of 6β-hydroxycortisol and the time course measurement of enzyme induction in man
    • 22 Ohnhaus EE, Breckenridge AM, Park BK. Urinary excretion of 6β-hydroxycortisol and the time course measurement of enzyme induction in man. Eur J Clin Pharmacol 1989; 36: 39-46.
    • (1989) Eur J Clin Pharmacol , vol.36 , pp. 39-46
    • Ohnhaus, E.E.1    Breckenridge, A.M.2    Park, B.K.3
  • 24
    • 0027999366 scopus 로고
    • Inhibition of caffeine metabolism by ciprofloxacin in children with cystic fibrosis as measured by the caffeine breath test
    • 24 Parker AC. Preston T, Heaf D, Kitteringham NR, Choonara I. Inhibition of caffeine metabolism by ciprofloxacin in children with cystic fibrosis as measured by the caffeine breath test. Br J Clin Pharmacol 1994; 38: 573-576.
    • (1994) Br J Clin Pharmacol , vol.38 , pp. 573-576
    • Parker, A.C.1    Preston, T.2    Heaf, D.3    Kitteringham, N.R.4    Choonara, I.5
  • 26
    • 0031594230 scopus 로고    scopus 로고
    • Induction of CYP1A2 activity by carbamazepine in children using the caffeine breath test
    • 26 Parker AC, Pritchard P, Preston T, Choonara I. Induction of CYP1A2 activity by carbamazepine in children using the caffeine breath test. Br J Clin Pharmacol 1998; 45: 176-178.
    • (1998) Br J Clin Pharmacol , vol.45 , pp. 176-178
    • Parker, A.C.1    Pritchard, P.2    Preston, T.3    Choonara, I.4
  • 27
    • 0026750647 scopus 로고
    • The Human Hepatic Cytochromes P450 involved in drug metabolism
    • 27 Wrighton SA, Stevens JC. The Human Hepatic Cytochromes P450 involved in drug metabolism. Crit Rev Toxicology 1992; 22: 1-21.
    • (1992) Crit Rev Toxicology , vol.22 , pp. 1-21
    • Wrighton, S.A.1    Stevens, J.C.2
  • 29
    • 0022446057 scopus 로고
    • Tenfold errors in administration of drug doses: A neglected iatrogenic disease in pediatrics
    • 29 Koren G, Barzilay Z, Greenwald M. Tenfold errors in administration of drug doses: a neglected iatrogenic disease in pediatrics. Pediatrics 1986; 77: 848-849.
    • (1986) Pediatrics , vol.77 , pp. 848-849
    • Koren, G.1    Barzilay, Z.2    Greenwald, M.3
  • 30
    • 0029849222 scopus 로고    scopus 로고
    • FDA Center for Drug Evaluation and Research (CDER) Pediatric Plan and New Regulations
    • 30 Roberts R, Maldonado S. FDA Center for Drug Evaluation and Research (CDER) Pediatric Plan and New Regulations. Drug Information Journal 1996; 30: 1125-1127.
    • (1996) Drug Information Journal , vol.30 , pp. 1125-1127
    • Roberts, R.1    Maldonado, S.2
  • 31
    • 0003074565 scopus 로고    scopus 로고
    • Licensing of Medicines for Children in the USA
    • 31 Nahata MC. Licensing of Medicines for Children in the USA. Paediatric Perinatal Drug Ther 1997; 1: 50-51.
    • (1997) Paediatric Perinatal Drug Ther , vol.1 , pp. 50-51
    • Nahata, M.C.1
  • 32
    • 0032558219 scopus 로고    scopus 로고
    • Children are not small adults
    • 32 Moore P. Children are not small adults. Lancet 1998; 352: 630.
    • (1998) Lancet , vol.352 , pp. 630
    • Moore, P.1
  • 33
    • 0032717908 scopus 로고    scopus 로고
    • The Paediatric Pharmacology Research Unit Network. Proof of Concept
    • 33 Kearns G. The Paediatric Pharmacology Research Unit Network. Proof of Concept. Paediatric and Perinatal Drug Therapy 1999; 3: 9-14.
    • (1999) Paediatric and Perinatal Drug Therapy , vol.3 , pp. 9-14
    • Kearns, G.1
  • 34
    • 0032426482 scopus 로고    scopus 로고
    • The safety of medicines used in children
    • 34 Brown EG, Choonara I. The safety of medicines used in children. Int J Pharmaceut Med 1998; 12: 285-288.
    • (1998) Int J Pharmaceut Med , vol.12 , pp. 285-288
    • Brown, E.G.1    Choonara, I.2
  • 35
    • 0032894078 scopus 로고    scopus 로고
    • Respiratory depression in children receiving diazepam for acute seizures-a prospective study
    • 35 Norris E, Marzouk O, Nunn AJ, McIntyre J, Choonara I. Respiratory depression in children receiving diazepam for acute seizures-a prospective study. Dev Med Child Neurol 1999; 41: 340-343.
    • (1999) Dev Med Child Neurol , vol.41 , pp. 340-343
    • Norris, E.1    Marzouk, O.2    Nunn, A.J.3    McIntyre, J.4    Choonara, I.5


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.