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Results: 1 to 20 of 25

1.

Clinical trials of drugs used off-label in neonates: ethical issues and alternative study designs.

Amin SB, McDermott MP, Shamoo AE.

Account Res. 2008 Jul-Sep;15(3):168-87. doi: 10.1080/08989620802194392.

PMID:
18792537
[PubMed - indexed for MEDLINE]
Free PMC Article
2.

Criteria supporting the study of drugs in the newborn.

Ward RM, Benitz WE, Benjamin DK Jr, Blackmon L, Giacoia GP, Hudak M, Lasky T, Rodriguez W, Selen A.

Clin Ther. 2006 Sep;28(9):1385-98. Review.

PMID:
17062311
[PubMed - indexed for MEDLINE]
3.

Ethical challenges in neonatal research: Summary report of the ethics group of the newborn drug development initiative.

Baer GR, Nelson RM; Ethics Group of the Newborn Drug Development Initiative.

Clin Ther. 2006 Sep;28(9):1399-407. Review.

PMID:
17062312
[PubMed - indexed for MEDLINE]
4.

Drug studies in newborns: a therapeutic imperative.

Giacoia GP, Taylor-Zapata P, Zajicek A.

Clin Perinatol. 2012 Mar;39(1):11-23. doi: 10.1016/j.clp.2011.12.016. Epub 2012 Jan 21. Review.

PMID:
22341533
[PubMed - indexed for MEDLINE]
5.

Off-label use of medications in children undergoing sedation and anesthesia.

Smith MC, Williamson J, Yaster M, Boyd GJ, Heitmiller ES.

Anesth Analg. 2012 Nov;115(5):1148-54. doi: 10.1213/ANE.0b013e3182501b04. Epub 2012 Mar 26. Review.

PMID:
22451593
[PubMed - indexed for MEDLINE]
6.

Paediatric labelling requirements. Implications for pharmacokinetic studies.

Wilson JT, Kearns GL, Murphy D, Yaffe SJ.

Clin Pharmacokinet. 1994 Apr;26(4):308-25. Review.

PMID:
8013163
[PubMed - indexed for MEDLINE]
7.

Analgesia and anesthesia for neonates: study design and ethical issues.

Anand KJ, Aranda JV, Berde CB, Buckman S, Capparelli EV, Carlo WA, Hummel P, Lantos J, Johnston CC, Lehr VT, Lynn AM, Maxwell LG, Oberlander TF, Raju TN, Soriano SG, Taddio A, Walco GA.

Clin Ther. 2005 Jun;27(6):814-43. Review.

PMID:
16117988
[PubMed - indexed for MEDLINE]
8.

Overview, hurdles, and future work in adaptive designs: perspectives from a National Institutes of Health-funded workshop.

Coffey CS, Levin B, Clark C, Timmerman C, Wittes J, Gilbert P, Harris S.

Clin Trials. 2012 Dec;9(6):671-80. doi: 10.1177/1740774512461859.

PMID:
23250942
[PubMed - indexed for MEDLINE]
9.

Drug policy in Europe Research and funding in neonates: current challenges, future perspectives, new opportunities.

Jacqz-Aigrain E.

Early Hum Dev. 2011 Mar;87 Suppl 1:S27-30. doi: 10.1016/j.earlhumdev.2011.01.007. Epub 2011 Jan 26. Review.

PMID:
21269785
[PubMed - indexed for MEDLINE]
10.

Selected Proceedings of the NICHD/FDA newborn drug development initiative: Part II.

Giacoia GP, Mattison DR.

Clin Ther. 2006 Sep;28(9):1337-41. Review.

PMID:
17062307
[PubMed - indexed for MEDLINE]
11.

Cardiovascular support in preterm infants.

Evans JR, Lou Short B, Van Meurs K, Cheryl Sachs H.

Clin Ther. 2006 Sep;28(9):1366-84. Review.

PMID:
17062310
[PubMed - indexed for MEDLINE]
12.

Ethical issues in neonatal and pediatric clinical trials.

Laventhal N, Tarini BA, Lantos J.

Pediatr Clin North Am. 2012 Oct;59(5):1205-20. doi: 10.1016/j.pcl.2012.07.007. Epub 2012 Aug 26. Review.

PMID:
23036252
[PubMed - indexed for MEDLINE]
Free PMC Article
13.

The use of unlicensed and off-label medicines in the neonate.

Conroy S, McIntyre J.

Semin Fetal Neonatal Med. 2005 Apr;10(2):115-22. Epub 2005 Jan 25. Review.

PMID:
15701577
[PubMed - indexed for MEDLINE]
14.

Examination of the evidence for off-label use of gabapentin.

Mack A.

J Manag Care Pharm. 2003 Nov-Dec;9(6):559-68. Review.

PMID:
14664664
[PubMed - indexed for MEDLINE]
Free Article
15.
16.

Research in children.

Burns JP.

Crit Care Med. 2003 Mar;31(3 Suppl):S131-6. Review.

PMID:
12626958
[PubMed - indexed for MEDLINE]
17.

Summary of the comparative effectiveness review on off-label use of atypical antipsychotics.

Maher AR, Theodore G.

J Manag Care Pharm. 2012 Jun;18(5 Suppl B):S1-20. Review.

PMID:
22784311
[PubMed - indexed for MEDLINE]
Free Article
18.

Issues in the design of clinical trials for safety in HIV-infected children.

Lindsey JC, Kline MW.

Pediatr AIDS HIV Infect. 1996 Apr;7(2):69-82. Review.

PMID:
11361484
[PubMed - indexed for MEDLINE]
19.

How are drugs approved? Part 2: ethical foundations of clinical research.

Howland RH.

J Psychosoc Nurs Ment Health Serv. 2008 Feb;46(2):15-20. Review.

PMID:
18293779
[PubMed - indexed for MEDLINE]
20.

[Off-label use in child and adolescent psychiatry. An ongoing ethical, medical and legal problem].

K├Âlch M, Allroggen M, Fegert JM.

Nervenarzt. 2009 Jul;80(7):789-96. doi: 10.1007/s00115-009-2727-z. Review. German.

PMID:
19533077
[PubMed - indexed for MEDLINE]

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