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Items: 1 to 20 of 32

1.

Recent new drug approvals. Part 1: drugs with pediatric indications.

Shelton CM, Chhim RF, Christensen ML.

J Pediatr Pharmacol Ther. 2012 Oct;17(4):329-39. doi: 10.5863/1551-6776-17.4.329.

2.

Regulatory approvals of pediatric oncology drugs: previous experience and new initiatives.

Hirschfeld S, Ho PT, Smith M, Pazdur R.

J Clin Oncol. 2003 Mar 15;21(6):1066-73. Epub 2003 Feb 7. Review.

PMID:
12637472
4.

IOM Review of FDA--approved biologics labeled or studied for pediatric use.

Field MJ, Ellinger LK, Boat TF.

Pediatrics. 2013 Feb;131(2):328-35. doi: 10.1542/peds.2012-2412. Epub 2013 Jan 14. Review.

5.

Pediatric use of topical ophthalmic drugs.

Coulter RA.

Optometry. 2004 Jul;75(7):419-29. Review.

PMID:
15296375
6.

Review of oncology and hematology drug product approvals at the US Food and Drug Administration between July 2005 and December 2007.

Sridhara R, Johnson JR, Justice R, Keegan P, Chakravarty A, Pazdur R.

J Natl Cancer Inst. 2010 Feb 24;102(4):230-43. doi: 10.1093/jnci/djp515. Epub 2010 Jan 29. Review. Erratum in: J Natl Cancer Inst. 2010 Apr 21;102(8):578-9.

7.

Ultimate fate of oncology drugs approved by the us food and drug administration without a randomized Trial.

Tsimberidou AM, Braiteh F, Stewart DJ, Kurzrock R.

J Clin Oncol. 2009 Dec 20;27(36):6243-50. doi: 10.1200/JCO.2009.23.6018. Epub 2009 Oct 13. Review.

PMID:
19826112
9.

Keeping up with current drug approvals.

Kupecz D.

Nurse Pract. 1999 Feb;24(2):44-8, 54, 56-7; quiz 58-9. Review.

PMID:
10048078
10.

Prescribing medications in pediatrics: concerns regarding FDA approval and pharmacokinetics.

Novak E, Allen PJ.

Pediatr Nurs. 2007 Jan-Feb;33(1):64-70. Review.

PMID:
17411005
11.

The economics of pediatric formulation development for off-patent drugs.

Milne CP, Bruss JB.

Clin Ther. 2008 Nov;30(11):2133-45. doi: 10.1016/j.clinthera.2008.11.019. Review.

PMID:
19108801
12.

Patient-reported outcomes supporting anticancer product approvals.

Rock EP, Kennedy DL, Furness MH, Pierce WF, Pazdur R, Burke LB.

J Clin Oncol. 2007 Nov 10;25(32):5094-9. Review.

PMID:
17991927
13.

Pediatric research: coming of age in the new millennium.

Milne CP.

Am J Ther. 1999 Sep;6(5):263-82. Review.

PMID:
11329108
14.

[Prescription of psychotropic drugs in paediatry: approved indications and therapeutic perspectives].

Dumortier G, Welniarz B, Sauvebois C, Medjdoub H, Friche H, Siad N, Degrassat K.

Encephale. 2005 Jul-Aug;31(4 Pt 1):477-89. Review. French.

PMID:
16389715
15.

Accelerated approval of oncology products: a decade of experience.

Dagher R, Johnson J, Williams G, Keegan P, Pazdur R.

J Natl Cancer Inst. 2004 Oct 20;96(20):1500-9. Review.

16.

Economics of new oncology drug development.

DiMasi JA, Grabowski HG.

J Clin Oncol. 2007 Jan 10;25(2):209-16. Review.

PMID:
17210942
17.

The US orphan drug programme 1983-1995.

Shulman SR, Manocchia M.

Pharmacoeconomics. 1997 Sep;12(3):312-26. Review.

PMID:
10170457
18.

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
19.

Pharmaceutical innovation in the 21st century: new drug approvals in the first decade, 2000-2009.

Kaitin KI, DiMasi JA.

Clin Pharmacol Ther. 2011 Feb;89(2):183-8. doi: 10.1038/clpt.2010.286. Epub 2010 Dec 29. Review.

PMID:
21191382
20.

The march toward rational therapeutics in children.

Gorman RL.

Pediatr Infect Dis J. 2003 Dec;22(12):1119-23. Review.

PMID:
14688584
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