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Items: 1 to 20 of 22

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.

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
3.

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
4.

Pediatric research: coming of age in the new millennium.

Milne CP.

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

PMID:
11329108
5.
6.

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
7.

An empirical review of major legislation affecting drug development: past experiences, effects, and unintended consequences.

Kesselheim AS.

Milbank Q. 2011 Sep;89(3):450-502. doi: 10.1111/j.1468-0009.2011.00636.x. Review.

8.

Accelerated approval of oncology products: the food and drug administration experience.

Johnson JR, Ning YM, Farrell A, Justice R, Keegan P, Pazdur R.

J Natl Cancer Inst. 2011 Apr 20;103(8):636-44. doi: 10.1093/jnci/djr062. Epub 2011 Mar 21. Review.

PMID:
21422403
9.

FDA update.

Katz R.

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

PMID:
16377143
10.

Proposed 'grant-and-access' program with price caps could stimulate development of drugs for very rare diseases.

Valverde AM, Reed SD, Schulman KA.

Health Aff (Millwood). 2012 Nov;31(11):2528-35. doi: 10.1377/hlthaff.2012.0235. Review.

11.

Paediatric cardiovascular clinical trials: an analysis of ClinicalTrials.gov and the Food and Drug Administration Pediatric Drug Labeling Database.

Hill KD, Henderson HT, Hornik CP, Li JS.

Cardiol Young. 2015 Aug;25 Suppl 2:172-80. doi: 10.1017/S1047951115000980. Review.

12.
13.

Trials of antihypertensive therapies in children.

Wells TG.

Blood Press Monit. 1999 Jun-Aug;4(3-4):189-92. Review.

PMID:
10490874
15.

Repaglinide : a pharmacoeconomic review of its use in type 2 diabetes mellitus.

Plosker GL, Figgitt DP.

Pharmacoeconomics. 2004;22(6):389-411. Review.

PMID:
15099124
16.

Incentives for increasing prenatal care use by women in order to improve maternal and neonatal outcomes.

Till SR, Everetts D, Haas DM.

Cochrane Database Syst Rev. 2015 Dec 15;(12):CD009916. doi: 10.1002/14651858.CD009916.pub2. Review.

PMID:
26671418
17.
18.

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.

PMID:
20118413
19.

The industrialization of clinical research.

Rettig RA.

Health Aff (Millwood). 2000 Mar-Apr;19(2):129-46. Review.

20.

Extensions of indication throughout the drug product lifecycle: a quantitative analysis.

Langedijk J, Whitehead CJ, Slijkerman DS, Leufkens HG, Schutjens MH, Mantel-Teeuwisse AK.

Drug Discov Today. 2016 Feb;21(2):348-55. doi: 10.1016/j.drudis.2015.11.009. Epub 2015 Dec 2. Review.

PMID:
26657087

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