Paediatric clinical pharmacology - At the beginning of a new era

European Journal of Clinical Pharmacology

Volumn 64, Issue 2, 2008, Pages 201-205

  Hoppu, Kalle ^a,b  

^a HELSINKI UNIVERSITY CENTRAL HOSPITAL   (Finland)

^b UNIVERSITY OF HELSINKI   (Finland)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL PHARMACOLOGY; CLINICAL PRACTICE; CLINICAL TRIAL; DECISION MAKING; DRUG SURVEILLANCE PROGRAM; ECONOMIC ASPECT; ETHICS; HUMAN; LAW; MEDICAL RESEARCH; NONHUMAN; PEDIATRICS; PHARMACOGENETICS; PRIORITY JOURNAL; PUBLIC HEALTH; QUALITATIVE ANALYSIS; REVIEW; RISK ASSESSMENT; SAFETY; TECHNOLOGY; WORLD HEALTH ORGANIZATION;

BIOMEDICAL RESEARCH; CHILD; HISTORY, 20TH CENTURY; HISTORY, 21ST CENTURY; HUMANS; LEGISLATION, DRUG; PEDIATRICS; PHARMACEUTICAL PREPARATIONS; PHARMACOLOGY, CLINICAL;

EID: 39149118018     PISSN: 00316970     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00228-007-0390-5     Document Type: Review

References (43)

1. Dost FH, Repges R (1968) Zur Beschreibung der Pharmakokinetik der Bromsulphalein-Ausscheiding unter Verwendung des Analog-Computers. Pharmacologia Clinica (Eur J Clin Pharmacol) 1(1):1-7
2. Silverman W, Andersen D, Blanc W, Crozier D (1956) A difference in mortality rate and incidence of kernicterus among premature infants allotted to two prophylactic antibacterial regimens. Pediatrics 18:614-625
3. Burns L, Hodgman J, Cass A (1959) Fatal circulatory collapse in premature infants receiving chloramphenicol. N Engl J Med 261(26):1318-1321
4. Krauer B, Spring P, Dettli L (1968) Zur Pharmakokinetik der Sulphonamide im ersten Lebensjahr. Pharmacologia Clinica (Eur J Clin Pharmacol) 1:47-53
5. (1980) European Journal of Clinical Pharmacology 18(1):1-128
6. Kearns GL, Abdel-Rahman SM, Alander SW, Blowey DL, Leeder JS, Kauffman RE (2003) Developmental pharmacology-drug disposition, action, and therapy in infants and children. N Engl J Med 349(12):1157-1167
7. Jacqz-Aigrain E, Choonara I (eds) (2006) Paediatric clinical pharmacology. Informa Healthcare
8. Yaffe SJ, Aranda JV (eds) (2005) Neonatal and pediatric pharmacology. Therapeutic principles in practice. Lippincott Williams & Wilkins, Philadelphia
9. Gill D (2004) Ethical principles and operational guidelines for good clinical practice in paediatric research. Recommendations of the Ethics Working Group of the Confederation of European Specialists in Paediatrics (CESP). Eur J Pediatr 163(2):53-57
10. Abdel-Rahman SM, Reed MD, Wells TG, Kearns GL (2007) Considerations in the rational design and conduct of phase I/II pediatric clinical trials: avoiding the problems and pitfalls. Clin Pharmacol Ther 81(4):483-494
11. Caldwell PH, Murphy SB, Butow PN, Craig JC (2004) Clinical trials in children. Lancet 364(9436):803-811
12. Schreiner MS (2003) Paediatric clinical trials: redressing the imbalance. Nat Rev Drug Discov 2(12):949-961
13. Steinbrook R (2002) Testing medications in children. N Engl J Med 347(18):1462-1470
14. Fanta S, Jönsson S, Backman J, Karlsson M, Hoppu K (2007) Developmental pharmacokinetics of ciclosporin-a population pharmacokinetic study in paediatric renal transplant candidates. Br J Clin Pharmacol. DOI 10.1111/j.1365-2125.2007.03003.x
15. Blake MJ, Gaedigk A, Pearce RE, Bomgaars LR, Christensen ML, Stowe C, James LP, Wilson JT, Kearns GL, Leeder JS (2007) Ontogeny of dextromethorphan O- and N-demethylation in the first year of life. Clin Pharmacol Ther 81(4):510-516
16. Balakrishnan K, Grieve J, Tordoff J, Norris P, Reith D (2006) Pediatric licensing status and the availability of suitable formulations for new medical entities approved in the United States between 1998 and 2002. J Clin Pharmacol 46(9):1038-1043
17. Hoppu K, Jaakkola R (1996) Children. The orphans of drug therapy-a longstanding, still current problem (in Finnish with English summary). TABU 4(5):6-10
18. Chui J, Tordoff J, Kennedy J, Reith D (2004) Trends in accessibility to medicines for children in New Zealand: 1998-2002. Br J Clin Pharmacol 57(3):322-327
19. Ceci A, Felisi M, Baiardi P, Bonifazi F, Catapano M, Giaquinto C, Nicolosi A, Sturkenboom M, Neubert A, Wong I (2006) Medicines for children licensed by the European Medicines Agency (EMEA): the balance after 10 years. Eur J Clin Pharmacol 62(11):947-952
20. Conroy S, Choonara I, Impicciatore P, Mohn A, Arnell H, Rane A, Knoeppel C, Seyberth H, Pandolfini C, Raffaeli M, Rocchi F, Bonati M, Jong G, de Hoog M, van den Anker J (2000) Survey of unlicensed and off label drug use in paediatric wards in European countries. BMJ 320:79-82
21. 't Jong GW, Vulto AG, de Hoog M, Schimmel KJM, Tibboel D, van den Anker J (2001) A survey of the use of off-label and unlicensed drugs in a Dutch children's hospital. Pediatrics 108:1089-1093
22. American Academy of Pediatrics, Committee on Drugs (2002) Uses of drugs not prescribed in the package insert (off-label uses). Pediatrics 110(1):181-183
23. Gazarian M, Kelly M, McPhee JR, Graudins LV, Ward RL, Campbell T (2006) Off-label use of medicines: consensus recommendations for evaluating appropriateness. Med J Austr 185(10):544-548
24. Balakrishnan K, Tordoff J, Norris P, Reith D (2007) Establishing a baseline for the monitoring of medicines availability for children in the UK: 1998-2002. Br J Clin Pharmacol 63(1):85-91
25. Choonara I, Conroy S (2002) Unlicensed and off-label drug use in children: implications for safety. Drug Saf 25(1):1-5
26. Roberts R, Rodriguez W, Murphy D, Crescenzi T (2003) Pediatric drug labeling. Improving the safety and efficacy of pediatric therapies. JAMA 290(7):905-911
27. Ward RM, Kauffman R (2007) Future of pediatric therapeutics: reauthorization of BPCA and PREA. Clin Pharmacol Ther 81(4):477-479
28. Li JS, Eisenstein EL, Grabowski HG, Reid ED, Mangum B, Schulman KA, Goldsmith JV, Murphy MD, Califf RM, Benjamin DK Jr (2007) Economic return of clinical trials performed under the pediatric exclusivity program. JAMA 297(5):480-488
29. (2006) Regulation (EC) no 1901/2006 of the European Parliament and of the Council on Medicinal Products for Paediatric Use and Amending Regulation (EEC) no. 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) no. 726/2004. http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-1/ reg_2006_1901/reg_2006_1901_en.pdf)
30. Dunne J (2007) The European regulation on medicines for paediatric use. Paed Resp Rev 8(2):177-183
31. Chui J, Tordoff J, Reith D (2005) Changes in availability of paediatric medicines in Australia between 1998 and 2002. Br J Clin Pharmacol 59(6):736-742
32. (2007) Resolution WHA60.20: Better medicines for children. http://www.who.int/gb/ebwha/pdf_files/WHA60/A60_R20-en.pdf)
33. Hill S, Gray A, Weber M (2007) Setting standards for essential children's medicines. Bull World Health Organ 85(9):650
34. Cohen SN (1999) The Pediatric Pharmacology Research Unit (PPRU) Network and its role in meeting pediatric labeling needs. Pediatrics 104(3 Pt 2):644-645
35. Bonati M, Breitkreutz J, Choonara I, Hoppu K, Jacqz-Aigrain E, Langendries J-P, Pons G, Rane A, Seyberth H, van den Acker J (2006) Paediatric clinical pharmacology in Europe. Paed Perinat Drug Ther 7(3):134-137
36. Peto R, Baigent C (1998) Trials: the next 50 years. Large scale randomised evidence of moderate benefits. BMJ 317(7167):1170-1171
37. Committee For Medicinal Products For Human Use (CHMP) (2006) Guideline on clinical trials in small populations (CHMP/EWP/83561/2005). European Medicines Agency, London
38. (2007) Promoting safety of medicines for children. WHO, Geneva
39. Mathis LL, Iyasu S (2007) Safety monitoring of drugs granted exclusivity under the Best Pharmaceuticals for Children Act: what the FDA has learned. Clin Pharmacol Ther 82(2):133-134
40. Committee For Medicinal Products For Human Use (CHMP) (2007) Guideline on conduct of pharmacovigilance for medicines used by the paediatric population (EMEA/CHMP/PhVWP/235910/2005-rev.1). European Medicines Agency, London. http://www.emea.europa.eu/pdfs/human/phvwp/23591005enfinal.pdf)
41. Hoppu K (2006) 2006: An exceptional year for international paediatric clinical pharmacology. Pharmacol Int (67):6-7
42. Stephenson T (2007) "Bonne Annee", "Gutes Neues Jahr"? Will 2007 be a "Happy New Year" for children's medicines in Europe? Arch Dis Child 92(8):661-663
43. MacLeod S, Peterson R, Wang Y, Li Z, Gui Y, Schaller J (2007) Challenges in international pediatric pharmacology. A milestone meeting in Shanghai. Ped Drugs 9(4):215-218