-
1
-
-
83155188467
-
Learning about the safety of drugs: A half-century of evolution
-
J. Avorn Learning about the safety of drugs: a half-century of evolution N Engl J Med 365 2011 2151 2153
-
(2011)
N Engl J Med
, vol.365
, pp. 2151-2153
-
-
Avorn, J.1
-
3
-
-
80051823470
-
Fatal cardiovascular collapse of infants receiving large amounts of chloramphenicol
-
J.M. Sutherland Fatal cardiovascular collapse of infants receiving large amounts of chloramphenicol AMA J Dis Child 97 1959 761 767
-
(1959)
AMA J Dis Child
, vol.97
, pp. 761-767
-
-
Sutherland, J.M.1
-
4
-
-
0000022275
-
A difference in mortality rate and incidence of kernicterus among premature infants allotted to two prophylactic antibacterial regimens
-
D.H. Andersen, W.A. Blanc, D.N. Crozier, and W.A. Silverman A difference in mortality rate and incidence of kernicterus among premature infants allotted to two prophylactic antibacterial regimens Pediatrics 18 1956 614 625
-
(1956)
Pediatrics
, vol.18
, pp. 614-625
-
-
Andersen, D.H.1
Blanc, W.A.2
Crozier, D.N.3
Silverman, W.A.4
-
5
-
-
0001741097
-
Novobiocin and neonatal hyperbilirubinemia: An investigation of the relationship in an epidemic of neonatal hyperbilirubinemia
-
J.M. Sutherland, and W.H. Keller Novobiocin and neonatal hyperbilirubinemia: an investigation of the relationship in an epidemic of neonatal hyperbilirubinemia Arch Pediatr Adolesc Med 101 1961 447 453
-
(1961)
Arch Pediatr Adolesc Med
, vol.101
, pp. 447-453
-
-
Sutherland, J.M.1
Keller, W.H.2
-
6
-
-
0021796152
-
Relationship of prolonged pharmacologic serum levels of vitamin E to incidence of sepsis and necrotizing enterocolitis in infants with birth weight 1,500 grams or less
-
L. Johnson, F.W. Bowen Jr., S. Abbasi, N. Herrmann, M. Weston, and L. Sacks Relationship of prolonged pharmacologic serum levels of vitamin E to incidence of sepsis and necrotizing enterocolitis in infants with birth weight 1,500 grams or less Pediatrics 75 1985 619 638 (Pubitemid 15079510)
-
(1985)
Pediatrics
, vol.75
, Issue.4
, pp. 619-638
-
-
Johnson, L.1
Bowen Jr., F.W.2
Abbasi, S.3
-
7
-
-
0013818733
-
Antibiotics for the newborn infant; A discussion of dosages
-
S.J. Yaffe Antibiotics for the newborn infant; a discussion of dosages Clin Pediatr (Phila) 4 1965 639 643
-
(1965)
Clin Pediatr (Phila)
, vol.4
, pp. 639-643
-
-
Yaffe, S.J.1
-
8
-
-
0037368831
-
Reflections on errors in neonatology: II. The "Heroic" years, 1950 to 1970
-
DOI 10.1038/sj.jp.7210843
-
A.F. Robertson Reflections on errors in neonatology: II. The "heroic" years, 1950 to 1970 J Perinatol 23 2003 154 161 (Pubitemid 36511745)
-
(2003)
Journal of Perinatology
, vol.23
, Issue.2
, pp. 154-161
-
-
Robertson, A.F.1
-
10
-
-
33750062269
-
Selected Proceedings of the NICHD/FDA newborn drug development initiative: Part II
-
DOI 10.1016/j.clinthera.2006.09.003, PII S0149291806002104
-
G.P. Giacoia, and D.R. Mattison Selected proceedings of the NICHD/FDA newborn drug development initiative: part II Clin Ther 28 2006 1337 1341 (Pubitemid 44585281)
-
(2006)
Clinical Therapeutics
, vol.28
, Issue.9
, pp. 1337-1341
-
-
Giacoia, G.P.1
Mattison, D.R.2
-
14
-
-
33947355479
-
Future of pediatric therapeutics: Reauthorization of BPCA and PREA
-
DOI 10.1038/sj.clpt.6100109, PII 6100109
-
R.M. Ward, and R. Kauffman Future of pediatric therapeutics: reauthorization of BPCA and PREA Clin Pharmacol Ther 81 2007 477 479 (Pubitemid 46452311)
-
(2007)
Clinical Pharmacology and Therapeutics
, vol.81
, Issue.4
, pp. 477-479
-
-
Ward, R.M.1
Kauffman, R.2
-
17
-
-
72149126826
-
-
US Food and Drug Administration Accessed December 29, 2011.
-
US Food and Drug Administration. Pediatric exclusivity labeling changes. http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/ PediatricTherapeuticsResearch/UCM163159.pdf. Accessed December 29, 2011.
-
Pediatric Exclusivity Labeling Changes
-
-
-
18
-
-
70450153933
-
Clinical trials in neonates: A therapeutic imperative
-
R.M. Ward, and S.E. Kern Clinical trials in neonates: a therapeutic imperative Clin Pharmacol Ther 86 2009 585 587
-
(2009)
Clin Pharmacol Ther
, vol.86
, pp. 585-587
-
-
Ward, R.M.1
Kern, S.E.2
-
19
-
-
70450145495
-
Neonatal pharmacology: Rational therapeutics for the most vulnerable
-
L. James, and S. Ito Neonatal pharmacology: rational therapeutics for the most vulnerable Clin Pharmacol Ther 86 2009 573 577
-
(2009)
Clin Pharmacol Ther
, vol.86
, pp. 573-577
-
-
James, L.1
Ito, S.2
-
20
-
-
84871370415
-
-
US National Institutes of Health. ClinicalTrials.gov Registry. Accessed March 12, 2012.
-
US National Institutes of Health. ClinicalTrials.gov Registry. www.clinicaltrials.gov. Accessed March 12, 2012.
-
-
-
-
21
-
-
0014244852
-
Therapeutic orphans
-
H. Shirkey Therapeutic orphans J Pediatr 72 1968 119 120
-
(1968)
J Pediatr
, vol.72
, pp. 119-120
-
-
Shirkey, H.1
-
22
-
-
0018691539
-
Drug utilization and reported adverse reactions in hospitalized children
-
A.A. Mitchell, P. Goldman, S. Shapiro, and D. Slone Drug utilization and reported adverse reactions in hospitalized children Am J Epidemiol 110 1979 196 204 (Pubitemid 10209703)
-
(1979)
American Journal of Epidemiology
, vol.110
, Issue.2
, pp. 196-204
-
-
Mitchell, A.A.1
Goldman, P.2
Shapiro, S.3
Slone, D.4
-
24
-
-
84857058983
-
Off-label and unlicensed medicine use and adverse drug reactions in children: A narrative review of the literature
-
J. Mason, M. Pirmohamed, and T. Nunn Off-label and unlicensed medicine use and adverse drug reactions in children: a narrative review of the literature Eur J Clin Pharmacol 68 2012 21 28
-
(2012)
Eur J Clin Pharmacol
, vol.68
, pp. 21-28
-
-
Mason, J.1
Pirmohamed, M.2
Nunn, T.3
-
25
-
-
79958834743
-
Neonatal pharmacology: Pharmacokinetics
-
P.J. Johnson Neonatal pharmacology: pharmacokinetics Neonatal Netw 30 2011 54 61
-
(2011)
Neonatal Netw
, vol.30
, pp. 54-61
-
-
Johnson, P.J.1
-
26
-
-
67651160651
-
Essentials for starting a pediatric clinical study (1): Pharmacokinetics in children
-
T. Yokoi Essentials for starting a pediatric clinical study (1): pharmacokinetics in children J Toxicol Sci 34 Suppl 2 2009 SP307 SP312
-
(2009)
J Toxicol Sci
, vol.34
, Issue.SUPPL. 2
-
-
Yokoi, T.1
-
27
-
-
0032005988
-
Delayed ontogenesis of CYP1A2 in the human liver
-
M. Sonnier, and T. Cresteil Delayed ontogenesis of CYP1A2 in the human liver Eur J Biochem 251 1998 893 898 (Pubitemid 28108986)
-
(1998)
European Journal of Biochemistry
, vol.251
, Issue.3
, pp. 893-898
-
-
Sonnier, M.1
Cresteil, T.2
-
28
-
-
0036185967
-
Unlicensed and off-label drug use in children: Implications for safety
-
I. Choonara, and S. Conroy Unlicensed and off-label drug use in children: implications for safety Drug Saf 25 2002 1 5 (Pubitemid 34208327)
-
(2002)
Drug Safety
, vol.25
, Issue.1
, pp. 1-5
-
-
Choonara, I.1
Conroy, S.2
-
29
-
-
0034642054
-
Unapproved and off-label use of drugs in a children's hospital
-
G.W. t Jong, A.G. Vulto, M. de Hoog, K.J. Schimmel, D. Tibboel, and J.N. van den Anker Unapproved and off-label use of drugs in a children's hospital N Engl J Med 343 2000 1125
-
(2000)
N Engl J Med
, vol.343
, pp. 1125
-
-
Jong, G.W.T.1
Vulto, A.G.2
De Hoog, M.3
Schimmel, K.J.4
Tibboel, D.5
Van Den Anker, J.N.6
-
30
-
-
0036120466
-
Unlicensed and off-label medication use in a neonatal intensive care unit: A prospective study
-
J. Barr, G. Brenner-Zada, E. Heiman, G. Pareth, M. Bulkowstein, and R. Greenberg Unlicensed and off-label medication use in a neonatal intensive care unit: a prospective study Am J Perinatol 19 2002 67 72 (Pubitemid 34229581)
-
(2002)
American Journal of Perinatology
, vol.19
, Issue.2
, pp. 67-72
-
-
Barr, J.1
Brenner-Zada, G.2
Heiman, E.3
Pareth, G.4
Bulkowstein, M.5
Greenberg, R.6
Berkovitch, M.7
-
31
-
-
33745315699
-
Reported medication use in the neonatal intensive care unit: Data from a large national data set
-
DOI 10.1542/peds.2005-1707
-
R.H. Clark, B.T. Bloom, A.R. Spitzer, and D.R. Gerstmann Reported medication use in the neonatal intensive care unit: data from a large national data set Pediatrics 117 2006 1979 1987 (Pubitemid 46071242)
-
(2006)
Pediatrics
, vol.117
, Issue.6
, pp. 1979-1987
-
-
Clark, R.H.1
Bloom, B.T.2
Spitzer, A.R.3
Gerstmann, D.R.4
-
33
-
-
84871393362
-
-
US National Institutes of Health Accessed March 15, 2012.
-
US National Institutes of Health. Pediatric trials network. http://pediatrictrials.org. Accessed March 15, 2012.
-
Pediatric Trials Network
-
-
-
34
-
-
27744574703
-
Newborns and drug studies: The NICHD/FDA newborn drug development initiative
-
DOI 10.1016/j.clinthera.2005.06.008
-
G.P. Giacoia, and D.R. Mattison Newborns and drug studies: the NICHD/FDA newborn drug development initiative Clin Ther 27 2005 796 813 (Pubitemid 41583528)
-
(2005)
Clinical Therapeutics
, vol.27
, Issue.6
, pp. 796-813
-
-
Giacoia, G.P.1
Mattison, D.R.2
-
35
-
-
3042558817
-
Ethical Conduct of clinical research involving children
-
Committee on Clinical Research Involving Children Committee on Clinical Research Involving Children Washington, DC
-
Committee on Clinical Research Involving Children Ethical Conduct of clinical research involving children M.J. Field, and R.E. Behrman Ethical conduct of clinical research involving children 2004 Committee on Clinical Research Involving Children Washington, DC
-
(2004)
Ethical Conduct of Clinical Research Involving Children
-
-
Field, M.J.1
Behrman, R.E.2
-
36
-
-
33750039170
-
Criteria supporting the study of drugs in the newborn
-
DOI 10.1016/j.clinthera.2006.09.007, PII S0149291806002141
-
R.M. Ward, W.E. Benitz, D.K. Benjamin Jr., L. Blackmon, G.P. Giacoia, and M. Hudak Criteria supporting the study of drugs in the newborn Clin Ther 28 2006 1385 1398 (Pubitemid 44585284)
-
(2006)
Clinical Therapeutics
, vol.28
, Issue.9
, pp. 1385-1398
-
-
Ward, R.M.1
Benitz, W.E.2
Benjamin Jr., D.K.3
Blackmon, L.4
Giacoia, G.P.5
Hudak, M.6
Lasky, T.7
Rodriguez, W.8
Selen, A.9
-
38
-
-
79951765993
-
Physiologically-based pharmacokinetics in drug development and regulatory science
-
M. Rowland, C. Peck, and G. Tucker Physiologically-based pharmacokinetics in drug development and regulatory science Annu Rev Pharmacol Toxicol 51 2011 45 73
-
(2011)
Annu Rev Pharmacol Toxicol
, vol.51
, pp. 45-73
-
-
Rowland, M.1
Peck, C.2
Tucker, G.3
-
39
-
-
70450270796
-
Developmental pharmacogenetics: A general paradigm for application to neonatal pharmacology and toxicology
-
J.S. Leeder Developmental pharmacogenetics: a general paradigm for application to neonatal pharmacology and toxicology Clin Pharmacol Ther 86 2009 678 682
-
(2009)
Clin Pharmacol Ther
, vol.86
, pp. 678-682
-
-
Leeder, J.S.1
-
40
-
-
79961142004
-
Paediatric drug development: Are population models predictive of pharmacokinetics across paediatric populations?
-
M. Cella, W. Zhao, E. Jacqz-Aigrain, D. Burger, M. Danhof, and O. Della Pasqua Paediatric drug development: are population models predictive of pharmacokinetics across paediatric populations? Br J Clin Pharmacol 72 2011 454 464
-
(2011)
Br J Clin Pharmacol
, vol.72
, pp. 454-464
-
-
Cella, M.1
Zhao, W.2
Jacqz-Aigrain, E.3
Burger, D.4
Danhof, M.5
Della Pasqua, O.6
-
41
-
-
70450257804
-
Clinical trial simulations in pediatric patients using realistic covariates: Application to teduglutide, a glucagon-like peptide-2 analog in neonates and infants with short-bowel syndrome
-
M. Mouksassi, J. Marier, J. Cyran, and A. Vinks Clinical trial simulations in pediatric patients using realistic covariates: application to teduglutide, a glucagon-like peptide-2 analog in neonates and infants with short-bowel syndrome Clin Pharmacol Ther 86 2009 667 671
-
(2009)
Clin Pharmacol Ther
, vol.86
, pp. 667-671
-
-
Mouksassi, M.1
Marier, J.2
Cyran, J.3
Vinks, A.4
-
42
-
-
84871360647
-
-
Hearing on reauthorization of PDUFA: What it means for jobs, innovation, and patients. Washington, DC: Energy and Commerce Committee, Health Subcommittee 2nd Session; 2012 (testimony of Daniel Frattarelli)
-
Hearing on reauthorization of PDUFA: What it means for jobs, innovation, and patients. Washington, DC: Energy and Commerce Committee, Health Subcommittee. 112th Congress, 2nd Session; 2012 (testimony of Daniel Frattarelli).
-
112th Congress
-
-
-
43
-
-
80051800077
-
Important role of population pharmacokinetic/pharmacodynamic modeling in pediatric therapeutics
-
A.A. Vinks Important role of population pharmacokinetic/pharmacodynamic modeling in pediatric therapeutics J Pediatr 159 2011 361 363
-
(2011)
J Pediatr
, vol.159
, pp. 361-363
-
-
Vinks, A.A.1
|