-
1
-
-
84921884934
-
-
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
-
-
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
-
-
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
-
-
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
-
-
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.
-
-
-
-
6
-
-
84893503265
-
Drug labeling and exposure in neonates
-
PID: 24322269
-
Laughon MM, Avant D, Tripathi N, Hornik CP, Cohen-Wolkowiez M, Clark RH, et al. Drug labeling and exposure in neonates. JAMA Pediatr. 2014;168(2):130–6.
-
(2014)
JAMA Pediatr
, vol.168
, Issue.2
, pp. 130-136
-
-
Laughon, M.M.1
Avant, D.2
Tripathi, N.3
Hornik, C.P.4
Cohen-Wolkowiez, M.5
Clark, R.H.6
-
7
-
-
0036305225
-
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
-
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
-
-
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
-
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
-
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
-
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
-
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
-
‘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
-
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
-
-
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.
-
-
-
-
17
-
-
85018342292
-
-
(eds), Wiley, Hoboken:
-
Mulberg AE, Murphy D, Dunne J, Mathis LL, editors. Pediatric drug development. Concepts and application. 2nd ed. Hoboken: Wiley; 2013.
-
(2013)
Pediatric drug development. Concepts and application
-
-
Mulberg, A.E.1
Murphy, D.2
Dunne, J.3
Mathis, L.L.4
-
19
-
-
77952784840
-
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
-
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
-
21
-
-
84879094814
-
The OHRP and SUPPORT
-
PID: 23738513
-
Wilfond BS, Magnus D, Antommaria AH, Appelbaum P, Aschner J, Barrington KJ, et al. The OHRP and SUPPORT. N Engl J Med. 2013;368(25):e36.
-
(2013)
N Engl J Med
, vol.368
, Issue.25
, pp. e36
-
-
Wilfond, B.S.1
Magnus, D.2
Antommaria, A.H.3
Appelbaum, P.4
Aschner, J.5
Barrington, K.J.6
-
22
-
-
84877733673
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
-
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
-
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
-
33
-
-
55849102471
-
Population pharmacokinetics of fluconazole in young infants
-
COI: 1:CAS:528:DC%2BD1cXhtlCgs7jL, PID: 18809946
-
Wade KC, Wu D, Kaufman DA, Ward RM, Benjamin DK Jr, Sullivan JE, et al. Population pharmacokinetics of fluconazole in young infants. Antimicrob Agents Chemother. 2008;52(11):4043–9.
-
(2008)
Antimicrob Agents Chemother
, vol.52
, Issue.11
, pp. 4043-4049
-
-
Wade, K.C.1
Wu, D.2
Kaufman, D.A.3
Ward, R.M.4
Benjamin, D.K.5
Sullivan, J.E.6
-
34
-
-
84900507506
-
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
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