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Items: 1 to 20 of 112

1.

Economic return of clinical trials performed under the pediatric exclusivity program.

Li JS, Eisenstein EL, Grabowski HG, Reid ED, Mangum B, Schulman KA, Goldsmith JV, Murphy MD, Califf RM, Benjamin DK Jr.

JAMA. 2007 Feb 7;297(5):480-8.

2.

The economic returns of pediatric clinical trials of antihypertensive drugs.

Baker-Smith CM, Benjamin DK Jr, Grabowski HG, Reid ED, Mangum B, Goldsmith JV, Murphy MD, Edwards R, Eisenstein EL, Sun J, Califf RM, Li JS.

Am Heart J. 2008 Oct;156(4):682-8. doi: 10.1016/j.ahj.2008.05.001.

3.

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.

4.

Peer-reviewed publication of clinical trials completed for pediatric exclusivity.

Benjamin DK Jr, Smith PB, Murphy MD, Roberts R, Mathis L, Avant D, Califf RM, Li JS.

JAMA. 2006 Sep 13;296(10):1266-73.

5.

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
6.

[Pediatric drug development: ICH harmonized tripartite guideline E11 within the United States of America, the European Union, and Japan].

Pflieger M, Bertram D.

Arch Pediatr. 2014 Oct;21(10):1129-38. doi: 10.1016/j.arcped.2014.07.011. Epub 2014 Aug 28. French.

PMID:
25175054
7.

Six-Month Market Exclusivity Extensions To Promote Research Offer Substantial Returns For Many Drug Makers.

Kesselheim AS, Rome BN, Sarpatwari A, Avorn J.

Health Aff (Millwood). 2017 Feb 1;36(2):362-370. doi: 10.1377/hlthaff.2016.1340. Epub 2017 Jan 18.

PMID:
28100464
8.

Incentives for orphan drug research and development in the United States.

Seoane-Vazquez E, Rodriguez-Monguio R, Szeinbach SL, Visaria J.

Orphanet J Rare Dis. 2008 Dec 16;3:33. doi: 10.1186/1750-1172-3-33.

10.

Follow-on biologics: data exclusivity and the balance between innovation and competition.

Grabowski H.

Nat Rev Drug Discov. 2008 Jun;7(6):479-88. doi: 10.1038/nrd2532. Epub 2008 May 12. Review.

PMID:
18469828
11.

Pediatric research: coming of age in the new millennium.

Milne CP.

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

PMID:
11329108
12.

Safety and transparency of pediatric drug trials.

Benjamin DK Jr, Smith PB, Sun MJ, Murphy MD, Avant D, Mathis L, Rodriguez W, Califf RM, Li JS.

Arch Pediatr Adolesc Med. 2009 Dec;163(12):1080-6. doi: 10.1001/archpediatrics.2009.229.

13.
14.

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
15.

Erlotinib: CP 358774, NSC 718781, OSI 774, R 1415.

Adis International Ltd..

Drugs R D. 2003;4(4):243-8.

PMID:
12848590
17.

Safety monitoring of drugs receiving pediatric marketing exclusivity.

Smith PB, Benjamin DK Jr, Murphy MD, Johann-Liang R, Iyasu S, Gould B, Califf RM, Li JS, Rodriguez W.

Pediatrics. 2008 Sep;122(3):e628-33. doi: 10.1542/peds.2008-0585.

18.

Measuring the patient health, societal and economic benefits of US pediatric therapeutics legislation.

Vernon JA, Shortenhaus SH, Mayer MH, Allen AJ, Golec JH.

Paediatr Drugs. 2012 Oct 1;14(5):283-94. doi: 10.2165/11633590-000000000-00000.

PMID:
22775493
19.

Research and development costs for new drugs by therapeutic category. A study of the US pharmaceutical industry.

DiMasi JA, Hansen RW, Grabowski HG, Lasagna L.

Pharmacoeconomics. 1995 Feb;7(2):152-69.

PMID:
10155302
20.

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

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