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Volumn 18, Issue 5, 2009, Pages 401-411

Opening the white boxes: The licensing documentation of efficacy and safety of psychotropic medicines for children

Author keywords

Children; Citalopram; Denmark; Efficacy; Licensing files; Methylphenidate; Safety

Indexed keywords

CITALOPRAM; METHYLPHENIDATE; PSYCHOTROPIC AGENT;

EID: 67649410690     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.1735     Document Type: Article
Times cited : (8)

References (42)
  • 1
    • 1442310685 scopus 로고    scopus 로고
    • Clinical trials in children and healthy volunteers. Quality and characteristics of notifications reviewed by the regulatory agencies in Finland
    • Keinonen T, Miettinen P, Saano V, Ylitalo P. Clinical trials in children and healthy volunteers. Quality and characteristics of notifications reviewed by the regulatory agencies in Finland. Paediatr Perinat Drug Ther 2003; 5: 175-182.
    • (2003) Paediatr Perinat Drug Ther , vol.5 , pp. 175-182
    • Keinonen, T.1    Miettinen, P.2    Saano, V.3    Ylitalo, P.4
  • 3
    • 0342301745 scopus 로고    scopus 로고
    • Lamotrigine-associated rash: Risk/benefit considerations in adults and children
    • Guberman AH, Besag FM, Brodie MJ, et al. Lamotrigine-associated rash: risk/benefit considerations in adults and children. Epilepsia 1999; 40: 985-991.
    • (1999) Epilepsia , vol.40 , pp. 985-991
    • Guberman, A.H.1    Besag, F.M.2    Brodie, M.J.3
  • 4
    • 40949116599 scopus 로고    scopus 로고
    • Assuring trial safety for children
    • Anonymous
    • Anonymous. Assuring trial safety for children. Lancet 2007; 371(9618): 1046.
    • (2007) Lancet , vol.371 , Issue.9618 , pp. 1046
  • 5
    • 0442324864 scopus 로고    scopus 로고
    • Assessment of health-related quality of life in children: A review of conceptual, methodological, and regulatory Issues
    • Matza LS, Swensen AR, Flood EM, Secnik K, Leidy NK. Assessment of health-related quality of life in children: a review of conceptual, methodological, and regulatory Issues. Value in Health 2004; 7: 79-7992.
    • (2004) Value in Health , vol.7 , pp. 79-7992
    • Matza, L.S.1    Swensen, A.R.2    Flood, E.M.3    Secnik, K.4    Leidy, N.K.5
  • 6
    • 69049088769 scopus 로고    scopus 로고
    • Regulation EC No. 1901/2006 of the European Parliament and of the Council of 12 December 2006 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.
    • Regulation EC No. 1901/2006 of the European Parliament and of the Council of 12 December 2006 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.
  • 7
    • 13144292424 scopus 로고    scopus 로고
    • Available at Accessed April 7, 2008
    • FDA Modernization Act of 1997. Available at www.fda.gov/cdrh/modact/ modguid.html Accessed April 7, 2008.
    • FDA Modernization Act of 1997
  • 8
    • 18744414518 scopus 로고    scopus 로고
    • Clinical trials of medication in children, 1996-2002
    • Sammons HM, Choorara I. Clinical trials of medication in children, 1996-2002. Eur J Clin Pharmacol 2005; 61: 165-167.
    • (2005) Eur J Clin Pharmacol , vol.61 , pp. 165-167
    • Sammons, H.M.1    Choorara, I.2
  • 9
    • 69049091908 scopus 로고    scopus 로고
    • Process for Handling Referrals to FDA under 21 CFR 50.54 Additional Safeguards for Children in Clinical Investigations12/22/2006. Available at www.fda.gov/cber/gdlns/childclininv.pdf Accessed April 7, 2008.
    • Process for Handling Referrals to FDA under 21 CFR 50.54 Additional Safeguards for Children in Clinical Investigations12/22/2006. Available at www.fda.gov/cber/gdlns/childclininv.pdf Accessed April 7, 2008.
  • 11
    • 1442311131 scopus 로고    scopus 로고
    • Facing the evidence: Antidepressant treatment in children and adolescents
    • Garland EJ. Facing the evidence: antidepressant treatment in children and adolescents. CMAJ 2004; 170: 489-491.
    • (2004) CMAJ , vol.170 , pp. 489-491
    • Garland, E.J.1
  • 12
    • 1442286563 scopus 로고    scopus 로고
    • Antidepressants and adverse effects in young patients: Uncovering the evidence
    • Herxheimer A, Barbara M. Antidepressants and adverse effects in young patients: uncovering the evidence. CMAJ 2004; 170: 487-488.
    • (2004) CMAJ , vol.170 , pp. 487-488
    • Herxheimer, A.1    Barbara, M.2
  • 13
    • 69049094936 scopus 로고    scopus 로고
    • Available at Accessed February 12, 2008
    • Medstat. Available at www.medstat.dk Accessed February 12, 2008.
    • Medstat
  • 14
    • 85102539083 scopus 로고    scopus 로고
    • 4th edn, John Wiley & Sons Ltd: West Sussex
    • Strom BL. Pharmacoepidemiology (4th edn). John Wiley & Sons Ltd: West Sussex, 2005.
    • (2005) Pharmacoepidemiology
    • Strom, B.L.1
  • 15
    • 0346789007 scopus 로고    scopus 로고
    • Efficacy and safety of Ritalin LA, a new, once daily, extended-release dosage form of methylphenidate, in children with attention deficit hyperactivity disorder
    • Biederman J, Quinn D, Weiss M, et al. Efficacy and safety of Ritalin LA, a new, once daily, extended-release dosage form of methylphenidate, in children with attention deficit hyperactivity disorder. Paediatr Drugs 2003; 5: 833-841.
    • (2003) Paediatr Drugs , vol.5 , pp. 833-841
    • Biederman, J.1    Quinn, D.2    Weiss, M.3
  • 16
    • 0042825435 scopus 로고    scopus 로고
    • Comparative efficacy of two once daily methylphenidate formulations (Ritalin® LA and Concerta®) and placebo in children with attention deficit hyperactivity disorder across the school day
    • Lopez F, Silva R, Muniz R. Comparative efficacy of two once daily methylphenidate formulations (Ritalin® LA and Concerta®) and placebo in children with attention deficit hyperactivity disorder across the school day. Paediatr Drugs 2003; 5: 545-555.
    • (2003) Paediatr Drugs , vol.5 , pp. 545-555
    • Lopez, F.1    Silva, R.2    Muniz, R.3
  • 17
    • 26444609135 scopus 로고    scopus 로고
    • Efficacy of two long-acting methylphenidate formulations in children with attention-deficit/hyperactivity disorder in a laboratory classroom setting
    • Silva R, Muniz R, Pestreich LK, Bram SM, Childress A, Lopez FA. Efficacy of two long-acting methylphenidate formulations in children with attention-deficit/hyperactivity disorder in a laboratory classroom setting. J Child Adolesc Psychopharmacol 2005; 15: 637-654.
    • (2005) J Child Adolesc Psychopharmacol , vol.15 , pp. 637-654
    • Silva, R.1    Muniz, R.2    Pestreich, L.K.3    Bram, S.M.4    Childress, A.5    Lopez, F.A.6
  • 22
    • 69049086610 scopus 로고    scopus 로고
    • Safety and tolerability of citalopram in children and adolescents
    • Monte Carlo
    • Rodseth D, Jayrajh J. Safety and tolerability of citalopram in children and adolescents. Poster, 2nd IFMAD meeting, Monte Carlo 2001.
    • (2001) Poster, 2nd IFMAD meeting
    • Rodseth, D.1    Jayrajh, J.2
  • 23
    • 69049118074 scopus 로고    scopus 로고
    • Department of Health and Ageing, Australian Government 2006: Public Summary Document for Methylphenidate hydrochloride, extended release tablets, 18 mg, 36mg and 54 mg, Concerta® March 2006. Available at http://www.health.gov.au/ Accessed June 2, 2008.
    • Department of Health and Ageing, Australian Government 2006: Public Summary Document for Methylphenidate hydrochloride, extended release tablets, 18 mg, 36mg and 54 mg, Concerta® March 2006. Available at http://www.health.gov.au/ Accessed June 2, 2008.
  • 24
    • 4243949263 scopus 로고    scopus 로고
    • Comparison of the efficacy and safety of OROS methylphenidate HCL with methylphenidate three times daily and placebo in children with ADHD
    • Swanson JM. Comparison of the efficacy and safety of OROS methylphenidate HCL with methylphenidate three times daily and placebo in children with ADHD. Paediatr Res 2000; 47: 34A.
    • (2000) Paediatr Res , vol.47
    • Swanson, J.M.1
  • 25
    • 17544402536 scopus 로고    scopus 로고
    • Once a day Concerta methylphenidate versus three-time-daily methylphenidate in laboratory and natural settings
    • Pelham WE, Gnagy EM, Burrows-Maclean L, et al. Once a day Concerta methylphenidate versus three-time-daily methylphenidate in laboratory and natural settings. Pediatrics 2001; 107(6): E105.
    • (2001) Pediatrics , vol.107 , Issue.6
    • Pelham, W.E.1    Gnagy, E.M.2    Burrows-Maclean, L.3
  • 26
    • 17944364081 scopus 로고    scopus 로고
    • Randomised controlled trial of OROS methylphenidate once a day in children with attention deficit/hyperactivity disorder
    • Wolraich ML, Greenhill LL, Pelham W, et al. Randomised controlled trial of OROS methylphenidate once a day in children with attention deficit/hyperactivity disorder. Pediatrics 2001; 108: 883-892.
    • (2001) Pediatrics , vol.108 , pp. 883-892
    • Wolraich, M.L.1    Greenhill, L.L.2    Pelham, W.3
  • 27
    • 33645740561 scopus 로고    scopus 로고
    • A randomised, controlled, effectiveness trial of OROS-methylphenidate compared to usual care with immediate release methylphenidate in attention deficit-hyperactivity disorder
    • Steele M, Weiss M, Swanson J, Wang J, Prinzo RS, Binder CF. A randomised, controlled, effectiveness trial of OROS-methylphenidate compared to usual care with immediate release methylphenidate in attention deficit-hyperactivity disorder. Can J Clin Pharmacol. 2006; 13: e50-e62.
    • (2006) Can J Clin Pharmacol , vol.13
    • Steele, M.1    Weiss, M.2    Swanson, J.3    Wang, J.4    Prinzo, R.S.5    Binder, C.F.6
  • 28
    • 19244370172 scopus 로고    scopus 로고
    • A dose-response study of OROS® methylphenidate in children with attention-deficit/ hyperactivity disorder
    • Stein MA, Sarampote CS,Waldman ID, et al. A dose-response study of OROS® methylphenidate in children with attention-deficit/ hyperactivity disorder. Pediatrics 2003; 112: e404-413.
    • (2003) Pediatrics , vol.112
    • Stein, M.A.1    Sarampote, C.S.2    Waldman, I.D.3
  • 29
    • 1642367699 scopus 로고    scopus 로고
    • A comparison of once-daily extended-release methylphenidate formulations in children with attention-deficit/hyperactivity disorder in the laboratory school (the Comacs Study)
    • Swanson JM, Wigal SB, Wigal T, et al. A comparison of once-daily extended-release methylphenidate formulations in children with attention-deficit/hyperactivity disorder in the laboratory school (the Comacs Study). Pediatrics 2004; 113: e206-e216.
    • (2004) Pediatrics , vol.113
    • Swanson, J.M.1    Wigal, S.B.2    Wigal, T.3
  • 30
    • 34250832736 scopus 로고    scopus 로고
    • The worldwide prevalence of ADHD: A systematic review and metaregression analysis
    • Polanczyk G, deLima MS, Horta BL, Biederman J, Rohde LA. The worldwide prevalence of ADHD: a systematic review and metaregression analysis. Am J Psychiatry 2007; 164: 942-948.
    • (2007) Am J Psychiatry , vol.164 , pp. 942-948
    • Polanczyk, G.1    deLima, M.S.2    Horta, B.L.3    Biederman, J.4    Rohde, L.A.5
  • 31
    • 69049088770 scopus 로고    scopus 로고
    • Guideline on clinical investigation of medicinal products for the treatment of obsessive compulsive disorder. CHMP/EWP/4279/02 London, 20 January 2005. Available at Accessed January 26, 2008
    • Guideline on clinical investigation of medicinal products for the treatment of obsessive compulsive disorder. CHMP/EWP/4279/02 London, 20 January 2005. Available at http://www.emea.europa.eu/pdfs/human/ewp/ 427902en.pdf Accessed January 26, 2008.
  • 32
    • 37749012096 scopus 로고    scopus 로고
    • Attention-deficit/ hyperactivity disorder in pediatric patients with epilepsy: Review of pharmacological treatment
    • Torres AR, Whitney J, Gonzalez-Heydrich J. Attention-deficit/ hyperactivity disorder in pediatric patients with epilepsy: review of pharmacological treatment. Epilepsy Behav 2008; 12: 217-233.
    • (2008) Epilepsy Behav , vol.12 , pp. 217-233
    • Torres, A.R.1    Whitney, J.2    Gonzalez-Heydrich, J.3
  • 33
    • 42549141631 scopus 로고    scopus 로고
    • Psychopharmacology of aggression in children and adolescents with autism: A critical review of efficacy and tolerability
    • Parikh MS, Kolevzon A, Hollander E. Psychopharmacology of aggression in children and adolescents with autism: a critical review of efficacy and tolerability. J Child Adolesc Psychopharmacol 2008; 18: 157-178.
    • (2008) J Child Adolesc Psychopharmacol , vol.18 , pp. 157-178
    • Parikh, M.S.1    Kolevzon, A.2    Hollander, E.3
  • 34
    • 0032761064 scopus 로고    scopus 로고
    • Psychotic side effects of psychostimulants: A 5-year review
    • Cherland E, Fitzpatrick R. Psychotic side effects of psychostimulants: a 5-year review. Can J Psychiatry 1999; 44: 811-813.
    • (1999) Can J Psychiatry , vol.44 , pp. 811-813
    • Cherland, E.1    Fitzpatrick, R.2
  • 35
    • 33645032330 scopus 로고    scopus 로고
    • The flawed basis for FDA post-marketing safety decisions: The example of anti-depressants and children
    • Klein DF. The flawed basis for FDA post-marketing safety decisions: the example of anti-depressants and children. Neuropsychopharmacology 2006; 31: 689-699.
    • (2006) Neuropsychopharmacology , vol.31 , pp. 689-699
    • Klein, D.F.1
  • 36
    • 69049099983 scopus 로고    scopus 로고
    • Committee for Medicinal Products for Human Use July 2007 Plenary Meeting Monthly report EMEA/318931/2007. Available at http://www.emea.europa.eu/ pdfs/human/press/pr/31893107en.pdf
    • Committee for Medicinal Products for Human Use July 2007 Plenary Meeting Monthly report EMEA/318931/2007. Available at http://www.emea.europa.eu/ pdfs/human/press/pr/31893107en.pdf
  • 37
    • 69049094935 scopus 로고    scopus 로고
    • Press Release: Meeting highlights from the Committee for Medicinal Products for Human Use, Ref. EMEA/431407/2007 London, 19 July 2007.
    • Press Release: Meeting highlights from the Committee for Medicinal Products for Human Use, Ref. EMEA/431407/2007 London, 19 July 2007.
  • 38
    • 69049105363 scopus 로고
    • Clinical trials: Towards a different model
    • Hansen EH, Launsø L. Clinical trials: towards a different model. J Pharm Clin 1987; 6: 67-74.
    • (1987) J Pharm Clin , vol.6 , pp. 67-74
    • Hansen, E.H.1    Launsø, L.2
  • 39
    • 0025457997 scopus 로고
    • Technology assessment of pharmaceuticals - the necessity of user perspective
    • Hansen EH. Technology assessment of pharmaceuticals - the necessity of user perspective. Cah Sociol Demogr Med 1990; 30: 313-327.
    • (1990) Cah Sociol Demogr Med , vol.30 , pp. 313-327
    • Hansen, E.H.1
  • 40
    • 0026664334 scopus 로고
    • Technology assessment in a user perspective - experiences with drug technology
    • Hansen EH. Technology assessment in a user perspective - experiences with drug technology. Int J Technol Assess Health Care 1992; 8: 150-165.
    • (1992) Int J Technol Assess Health Care , vol.8 , pp. 150-165
    • Hansen, E.H.1
  • 41
    • 34547845289 scopus 로고    scopus 로고
    • Creating knowledge about adverse drug reactions: A critical analysis of the Danish reporting system from 1968 to 2005
    • Aagaard L, Soendergaard B, Kampmann JP, Hansen EH. Creating knowledge about adverse drug reactions: a critical analysis of the Danish reporting system from 1968 to 2005. Soc Sci Med 2007; 65: 1296-1309.
    • (2007) Soc Sci Med , vol.65 , pp. 1296-1309
    • Aagaard, L.1    Soendergaard, B.2    Kampmann, J.P.3    Hansen, E.H.4
  • 42
    • 39849088723 scopus 로고    scopus 로고
    • Knowledge creation about ADRs - turning the perspective from the rear view mirror to the projector?
    • Aagaard L, Soendergaad B, Stenver DI, Hansen EH. Knowledge creation about ADRs - turning the perspective from the rear view mirror to the projector? Br J Clin Pharmacol 2007; 65: 364-376.
    • (2007) Br J Clin Pharmacol , vol.65 , pp. 364-376
    • Aagaard, L.1    Soendergaad, B.2    Stenver, D.I.3    Hansen, E.H.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.