메뉴 건너뛰기




Volumn 17, Issue 1, 2015, Pages 37-42

Ethics of Drug Studies in the Newborn

Author keywords

[No Author keywords available]

Indexed keywords

CHLORAMPHENICOL;

EID: 84921835753     PISSN: 11745878     EISSN: 11792019     Source Type: Journal    
DOI: 10.1007/s40272-014-0099-8     Document Type: Article
Times cited : (15)

References (35)
  • 1
    • 84921884934 scopus 로고    scopus 로고
    • Food and Drug Administration Modernization Act of 1997. (Public Law 105–115); 1997. Available from:. Accessed 27 July 2014
    • Food and Drug Administration Modernization Act of 1997. (Public Law 105–115); 1997. Available from: http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDAMA/FullTextofFDAMAlaw/default.htm. Accessed 27 July 2014.
  • 2
    • 84921890632 scopus 로고    scopus 로고
    • US Food and Drug Administration Safety and Innovation Act. (Public Law 112–144); 2012. Available from:. Accessed 27 July 2014
    • US Food and Drug Administration Safety and Innovation Act. (Public Law 112–144); 2012. Available from: http://www.gpo.gov/fdsys/pkg/PLAW-112publ144/pdf/PLAW-112publ144.pdf. Accessed 27 July 2014.
  • 3
    • 84921853646 scopus 로고    scopus 로고
    • The European Parliament and the Council of the European Union. Paediatric Regulation (EC No 1901/2006). 2006. Accessed 10 Oct 2014
    • The European Parliament and the Council of the European Union. Paediatric Regulation (EC No 1901/2006). 2006. http://ec.europa.eu/health/human-use/paediatric-medicines/index_en.htm. Accessed 10 Oct 2014.
  • 4
    • 84921880844 scopus 로고    scopus 로고
    • US Food and Drug Administration Pediatric Exclusivity Statistics. Last update July 28, 2014. Available from:. Accessed 29 July 2014
    • US Food and Drug Administration Pediatric Exclusivity Statistics. Last update July 28, 2014. Available from: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm050006.htm. Accessed 29 July 2014.
  • 5
    • 84921891132 scopus 로고    scopus 로고
    • US Food and Drug Administration New Pediatric Labeling Information Database. Last update July 28, 2014. Available from:. Accessed 28 July 2014
    • US Food and Drug Administration New Pediatric Labeling Information Database. Last update July 28, 2014. Available from: http://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?sd=labelingdatabase. Accessed 28 July 2014.
  • 7
    • 0036305225 scopus 로고    scopus 로고
    • Uses of drugs not described in the package insert (off-label uses)
    • American Academy of Pediatrics Committee on Drugs. Uses of drugs not described in the package insert (off-label uses). Pediatrics. 2002;110(1 Pt 1):181–3.
    • (2002) Pediatrics , vol.110 , pp. 181-183
    • American Academy of Pediatrics Committee on Drugs1
  • 8
    • 84970176594 scopus 로고
    • Pediatric drug investigation: current ethical guidelines
    • Mirkin BL, (ed), Year Book Medical Publishers, Inc., Chicago:
    • Lebacqz K. Pediatric drug investigation: current ethical guidelines. In: Mirkin BL, editor. Clinical pharmacology and therapeutics, a pediatric perspective. Chicago: Year Book Medical Publishers, Inc.; 1978. p. 279–97.
    • (1978) Clinical pharmacology and therapeutics, a pediatric perspective , pp. 279-297
    • Lebacqz, K.1
  • 9
    • 84921863858 scopus 로고    scopus 로고
    • Belmont Report: Ethical principles and guidelines for the protection of human subjects of research. Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 1979. Available from:. Accessed 24 July 2014
    • Belmont Report: Ethical principles and guidelines for the protection of human subjects of research. Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 1979. Available from: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html. Accessed 24 July 2014.
  • 10
    • 0028950350 scopus 로고
    • Committee on Drugs, American Academy of Pediatrics
    • Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Committee on Drugs, American Academy of Pediatrics. Pediatrics. 1995;95(2):286–94.
    • (1995) Pediatrics , vol.95 , Issue.2 , pp. 286-294
  • 11
    • 77950583461 scopus 로고    scopus 로고
    • Clinical report—guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations
    • PID: 20351010
    • Shaddy RE, Denne SC, Committee on Drugs and Committee on Pediatric Research. Clinical report—guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Pediatrics. 2010;125(4):850–60.
    • (2010) Pediatrics , vol.125 , Issue.4 , pp. 850-860
    • Shaddy, R.E.1    Denne, S.C.2    Committee on Drugs and Committee on Pediatric Research3
  • 12
    • 84921878618 scopus 로고    scopus 로고
    • Ethical considerations in conducting pediatric research
    • Mulberg AE, Murphy D, Dunne J, Mathis LL, (eds), Wiley, Hoboken:
    • Roth-Cline MD, Nelson RM. Ethical considerations in conducting pediatric research. In: Mulberg AE, Murphy D, Dunne J, Mathis LL, editors. Pediatric drug development, concepts and applications. Hoboken: Wiley; 2013. p. 83–97.
    • (2013) Pediatric drug development, concepts and applications , pp. 83-97
    • Roth-Cline, M.D.1    Nelson, R.M.2
  • 13
    • 84921835941 scopus 로고    scopus 로고
    • The consent and assent process in pediatric clinical trials
    • Mulberg AE, Murphy D, Dunne J, Mathis LL, (eds), Wiley, Hoboken:
    • Simar MR. The consent and assent process in pediatric clinical trials. In: Mulberg AE, Murphy D, Dunne J, Mathis LL, editors. Pediatic drug development, concepts and applications. Hoboken: Wiley; 2013. p. 94–104.
    • (2013) Pediatic drug development, concepts and applications , pp. 94-104
    • Simar, M.R.1
  • 14
    • 84921876794 scopus 로고    scopus 로고
    • ‘Last Update’
    • The Spinal Muscular Atrophy Drug Development Pipeline. 2014 ‘Last Update’ January 22, 2014. Available from: http://www.fsma.org/Research/DrugPipeline/. Accessed 27 July 2014.
    • (2014) January 22, 2014. Available from:
  • 15
    • 0003222493 scopus 로고
    • Fatal and circulatory collapse in premature infants receiving chloramphenicol
    • COI: 1:STN:280:DyaF3c7is1KksA%3D%3D, PID: 13806261
    • Burns LE, Hodgeman JE, Cass AB. Fatal and circulatory collapse in premature infants receiving chloramphenicol. N Engl J Med. 1959;261(26):1318–21.
    • (1959) N Engl J Med , vol.261 , Issue.26 , pp. 1318-1321
    • Burns, L.E.1    Hodgeman, J.E.2    Cass, A.B.3
  • 16
    • 84921863542 scopus 로고    scopus 로고
    • International Congress on Harmonization: Clinical Investigation of Medicinal Products in the Paediatric Population. ICH E11. Last update 2001. Available from:. Accessed 28 July 2014
    • International Congress on Harmonization: Clinical Investigation of Medicinal Products in the Paediatric Population. ICH E11. Last update 2001. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002926.pdf. Accessed 28 July 2014.
  • 19
    • 77952784840 scopus 로고    scopus 로고
    • Target ranges of oxygen saturation in extremely preterm infants
    • COI: 1:CAS:528:DC%2BC3cXmslOrtLw%3D, PID: 20472937
    • Carlo WA, Finer NN, Walsh MC, Rich W, Gantz MG, Laptook AR, et al. Target ranges of oxygen saturation in extremely preterm infants. N Engl J Med. 2010;362(21):1959–69.
    • (2010) N Engl J Med , vol.362 , Issue.21 , pp. 1959-1969
    • Carlo, W.A.1    Finer, N.N.2    Walsh, M.C.3    Rich, W.4    Gantz, M.G.5    Laptook, A.R.6
  • 20
    • 84889690322 scopus 로고    scopus 로고
    • What are reasonably foreseeable risks?
    • PID: 24256530
    • Resnik DB. What are reasonably foreseeable risks? Am J Bioeth. 2013;13(12):29–30.
    • (2013) Am J Bioeth , vol.13 , Issue.12 , pp. 29-30
    • Resnik, D.B.1
  • 22
    • 84877733673 scopus 로고    scopus 로고
    • Informed consent and SUPPORT
    • COI: 1:CAS:528:DC%2BC3sXnsl2gs70%3D, PID: 23593944
    • Drazen JM, Solomon CG, Greene MF. Informed consent and SUPPORT. N Engl J Med. 2013;368(20):1929–31.
    • (2013) N Engl J Med , vol.368 , Issue.20 , pp. 1929-1931
    • Drazen, J.M.1    Solomon, C.G.2    Greene, M.F.3
  • 23
    • 84879099673 scopus 로고    scopus 로고
    • In support of SUPPORT—a view from the NIH
    • COI: 1:CAS:528:DC%2BC3sXhtVSnu77J, PID: 23738511
    • Hudson KL, Guttmacher AE, Collins FS. In support of SUPPORT—a view from the NIH. N Engl J Med. 2013;368(25):2349–51.
    • (2013) N Engl J Med , vol.368 , Issue.25 , pp. 2349-2351
    • Hudson, K.L.1    Guttmacher, A.E.2    Collins, F.S.3
  • 24
    • 77957110462 scopus 로고    scopus 로고
    • Target ranges of oxygen saturation in extremely preterm infants
    • COI: 1:CAS:528:DC%2BC3cXht1Sit7%2FE, PID: 20860514, (author reply -6)
    • Tarnow-Mordi WO, Darlow B, Doyle L. Target ranges of oxygen saturation in extremely preterm infants. N Engl J Med. 2010;363(13):1285 (author reply -6).
    • (2010) N Engl J Med , vol.363 , Issue.13 , pp. 1285
    • Tarnow-Mordi, W.O.1    Darlow, B.2    Doyle, L.3
  • 25
    • 79960001765 scopus 로고    scopus 로고
    • The development of medicines for children. Part of a series on pediatric pharmacology, guest edited by Gianvincenzo Zuccotti, Emilio Clementi, and Massimo Molteni
    • PID: 21376810
    • Rocchi F, Tomasi P. The development of medicines for children. Part of a series on pediatric pharmacology, guest edited by Gianvincenzo Zuccotti, Emilio Clementi, and Massimo Molteni. Pharmacol Res. 2011;64(3):169–75.
    • (2011) Pharmacol Res , vol.64 , Issue.3 , pp. 169-175
    • Rocchi, F.1    Tomasi, P.2
  • 26
    • 84873456965 scopus 로고    scopus 로고
    • Population pharmacokinetic analysis during the first 2 years of life: an overview
    • COI: 1:CAS:528:DC%2BC3sXhsFemsbk%3D, PID: 23179579
    • Marsot A, Boulamery A, Bruguerolle B, Simon N. Population pharmacokinetic analysis during the first 2 years of life: an overview. Clin Pharmacokinet. 2012;51(12):787–98.
    • (2012) Clin Pharmacokinet , vol.51 , Issue.12 , pp. 787-798
    • Marsot, A.1    Boulamery, A.2    Bruguerolle, B.3    Simon, N.4
  • 27
    • 79951623383 scopus 로고    scopus 로고
    • Microassay of drugs and modern measurement techniques
    • PID: 21320232
    • Millership JS. Microassay of drugs and modern measurement techniques. Paediatr Anaesth. 2011;21(3):197–205.
    • (2011) Paediatr Anaesth , vol.21 , Issue.3 , pp. 197-205
    • Millership, J.S.1
  • 28
    • 84879974352 scopus 로고    scopus 로고
    • Individual and center-level factors affecting mortality among extremely low birth weight infants
    • PID: 23753096
    • Alleman BW, Bell EF, Li L, Dagle JM, Smith PB, Ambalavanan N, et al. Individual and center-level factors affecting mortality among extremely low birth weight infants. Pediatrics. 2013;132(1):e175–84.
    • (2013) Pediatrics , vol.132 , Issue.1 , pp. e175-e184
    • Alleman, B.W.1    Bell, E.F.2    Li, L.3    Dagle, J.M.4    Smith, P.B.5    Ambalavanan, N.6
  • 29
    • 0027482521 scopus 로고
    • The limit of viability–neonatal outcome of infants born at 22–25 weeks’ gestation
    • COI: 1:STN:280:DyaK2c%2FkvF2qtA%3D%3D, PID: 8179651
    • Allen MC, Donohue PK, Dusman AE. The limit of viability–neonatal outcome of infants born at 22–25 weeks’ gestation. N Engl J Med. 1993;329(22):1597–601.
    • (1993) N Engl J Med , vol.329 , Issue.22 , pp. 1597-1601
    • Allen, M.C.1    Donohue, P.K.2    Dusman, A.E.3
  • 30
    • 84872507763 scopus 로고    scopus 로고
    • Outcome at two years of age in a Swiss national cohort of extremely preterm infants born between 2000 and 2008
    • PID: 23272671
    • Schlapbach LJ, Adams M, Proietti E, Aebischer M, Grunt S, Borradori-Tolsa C, et al. Outcome at two years of age in a Swiss national cohort of extremely preterm infants born between 2000 and 2008. BMC Pediatr. 2012;12:198.
    • (2012) BMC Pediatr , vol.12 , pp. 198
    • Schlapbach, L.J.1    Adams, M.2    Proietti, E.3    Aebischer, M.4    Grunt, S.5    Borradori-Tolsa, C.6
  • 31
    • 84921849051 scopus 로고    scopus 로고
    • Office for Health Research Protection (OHRP)—Categories of Research. Categories of research that may be reviewed by the Institutional Review Board (IRB) through an expedited review procedure. Categories of Research (2)(b). Last update 1998. Available from:. Accessed 29 July 2014
    • Office for Health Research Protection (OHRP)—Categories of Research. Categories of research that may be reviewed by the Institutional Review Board (IRB) through an expedited review procedure. Categories of Research (2)(b). Last update 1998. Available from: http://www.hhs.gov/ohrp/policy/expedited98.html. Accessed 29 July 2014.
  • 32
    • 80052931159 scopus 로고    scopus 로고
    • Population pharmacokinetics of meropenem in plasma and cerebrospinal fluid of infants with suspected or complicated intra-abdominal infections
    • PID: 21829139
    • Smith PB, Cohen-Wolkowiez M, Castro LM, Poindexter B, Bidegain M, Weitkamp JH, et al. Population pharmacokinetics of meropenem in plasma and cerebrospinal fluid of infants with suspected or complicated intra-abdominal infections. Pediatr Infect Dis J. 2011;30(10):844–9.
    • (2011) Pediatr Infect Dis J , vol.30 , Issue.10 , pp. 844-849
    • Smith, P.B.1    Cohen-Wolkowiez, M.2    Castro, L.M.3    Poindexter, B.4    Bidegain, M.5    Weitkamp, J.H.6
  • 34
    • 84900507506 scopus 로고    scopus 로고
    • The pharmacokinetics of methadone and its metabolites in neonates, infants, and children
    • PID: 24666686
    • Ward RM, Drover DR, Hammer GB, Stemland CJ, Kern S, Tristani-Firouzi M, et al. The pharmacokinetics of methadone and its metabolites in neonates, infants, and children. Paediatr Anaesth. 2014;24(6):591–601.
    • (2014) Paediatr Anaesth , vol.24 , Issue.6 , pp. 591-601
    • Ward, R.M.1    Drover, D.R.2    Hammer, G.B.3    Stemland, C.J.4    Kern, S.5    Tristani-Firouzi, M.6


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.