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Items: 1 to 20 of 116

1.

Extrapolation of adult data and other data in pediatric drug-development programs.

Dunne J, Rodriguez WJ, Murphy MD, Beasley BN, Burckart GJ, Filie JD, Lewis LL, Sachs HC, Sheridan PH, Starke P, Yao LP.

Pediatrics. 2011 Nov;128(5):e1242-9. doi: 10.1542/peds.2010-3487. Epub 2011 Oct 24.

PMID:
22025597
2.

Improving pediatric dosing through pediatric initiatives: what we have learned.

Rodriguez W, Selen A, Avant D, Chaurasia C, Crescenzi T, Gieser G, Di Giacinto J, Huang SM, Lee P, Mathis L, Murphy D, Murphy S, Roberts R, Sachs HC, Suarez S, Tandon V, Uppoor RS.

Pediatrics. 2008 Mar;121(3):530-9. doi: 10.1542/peds.2007-1529.

PMID:
18310202
3.

Current regulatory policies regarding pediatric indications and exclusivity.

Rodriguez WJ, Roberts R, Murphy D.

J Pediatr Gastroenterol Nutr. 2003 Nov-Dec;37 Suppl 1:S40-5.

PMID:
14685077
4.

Adolescent dosing and labeling since the Food and Drug Administration Amendments Act of 2007.

Momper JD, Mulugeta Y, Green DJ, Karesh A, Krudys KM, Sachs HC, Yao LP, Burckart GJ.

JAMA Pediatr. 2013 Oct;167(10):926-32. doi: 10.1001/jamapediatrics.2013.465.

PMID:
23921678
5.

Pediatric pharmacology: the path clears for a noble mission.

Wilson JT.

J Clin Pharmacol. 1993 Mar;33(3):210-2.

PMID:
8463433
6.

Pediatric drug labeling: improving the safety and efficacy of pediatric therapies.

Roberts R, Rodriguez W, Murphy D, Crescenzi T.

JAMA. 2003 Aug 20;290(7):905-11.

PMID:
12928467
7.

Stimulation programs for pediatric drug research--do children really benefit?

Boots I, Sukhai RN, Klein RH, Holl RA, Wit JM, Cohen AF, Burggraaf J.

Eur J Pediatr. 2007 Aug;166(8):849-55. Epub 2007 Jan 17.

8.

FDA update.

Katz R.

Epilepsy Res. 2006 Jan;68(1):85-94. Review.

PMID:
16377143
9.

Pediatric oncology: regulatory initiatives.

Hirschfeld S, Shapiro A, Dagher R, Pazdur R.

Oncologist. 2000;5(6):441-4.

10.

Impact of pediatric exclusivity on drug labeling and demonstrations of efficacy.

Wharton GT, Murphy MD, Avant D, Goldsmith JV, Chai G, Rodriguez WJ, Eisenstein EL.

Pediatrics. 2014 Aug;134(2):e512-8. doi: 10.1542/peds.2013-2987. Epub 2014 Jul 14.

11.

Pediatric pharmacotherapy issues in Africa.

Gray A.

Paediatr Drugs. 2009;11(1):6-8.

PMID:
19127941
12.

Pediatric use of topical ophthalmic drugs.

Coulter RA.

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

PMID:
15296375
13.

Leveraging prior quantitative knowledge in guiding pediatric drug development: a case study.

Jadhav PR, Zhang J, Gobburu JV.

Pharm Stat. 2009 Jul-Sep;8(3):216-24. doi: 10.1002/pst.394.

PMID:
19610013
14.

Pediatric exclusivity: evolving legislation and novel complexities within pediatric therapeutic development.

Rivera DR, Hartzema AG.

Ann Pharmacother. 2014 Mar;48(3):369-79. doi: 10.1177/1060028013514031. Epub 2013 Dec 5. Review.

PMID:
24311725
15.

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
16.

Persisting decline in depression treatment after FDA warnings.

Libby AM, Orton HD, Valuck RJ.

Arch Gen Psychiatry. 2009 Jun;66(6):633-9. doi: 10.1001/archgenpsychiatry.2009.46.

PMID:
19487628
18.

[Are children getting the right drugs?].

Bratlid D.

Tidsskr Nor Laegeforen. 2005 Dec 1;125(23):3290-2. Norwegian.

20.

Status of drug approval processes and regulation of medications for children.

Kauffman RE.

Curr Opin Pediatr. 1995 Apr;7(2):195-8.

PMID:
7787936

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