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Links from PubMed

Items: 11

1.

The clinical pharmacogeneticist: an emerging regulatory scientist at the US Food and Drug Administration.

Zineh I, Woodcock J.

Hum Genomics. 2010 Apr;4(4):221-5. No abstract available.

2.

Should pharmacogenomic studies be required for new drug approval?

Relling MV, Hoffman JM.

Clin Pharmacol Ther. 2007 Mar;81(3):425-8. Review.

PMID:
17339872
3.

Translation of pharmacogenomics and pharmacogenetics: a regulatory perspective.

Lesko LJ, Woodcock J.

Nat Rev Drug Discov. 2004 Sep;3(9):763-9. Review.

PMID:
15340386
4.

Generic drug approval: a US perspective.

Nagori BP, Mathur V, Garg S.

Curr Med Res Opin. 2011 Mar;27(3):541-5. doi: 10.1185/03007995.2010.548374. Epub 2011 Jan 10. Review.

PMID:
21219120
5.

The challenge of regulating development and approval of drugs with pleiotropic action in cardiovascular disease.

Temple R.

Am J Cardiol. 1998 Apr 23;81(8A):5F-9F. Review. No abstract available.

PMID:
9604896
6.

Social norms and the evolution of drug regulation in the U.S.: implications for access to medications for HIV disease.

Smith SR, Kirking DM.

AIDS Public Policy J. 1999 Fall;14(3):105-16. Review. No abstract available.

PMID:
10935047
7.

Comprehensive reform of the new drug regulatory process.

Crooke ST.

Biotechnology (N Y). 1995 Jan;13(1):25-9. Review. No abstract available.

PMID:
9634747
8.

Nonclinical development of radiopharmaceuticals: regulatory considerations for the United States Food and Drug Administration.

Wilson S.

Ernst Schering Res Found Workshop. 2004;(48):151-65. Review. No abstract available.

PMID:
15248521
9.

Advances in cardiovascular pharmacology: protocol design and methodology--the US regulatory process.

Somberg JC, Borer JS.

Am J Ther. 1999 May;6(3):175-8. Review. No abstract available.

PMID:
10423661
10.

A Food and Drug Administration primer.

Simon LS.

Arthritis Rheum. 2006 Feb 15;55(1):4-8. Review. No abstract available.

11.

Overview of the US Food and Drug Administration's reform legislation.

Rheinstein PH.

Clin Ther. 1998;20 Suppl C:C4-11. Review.

PMID:
9915084

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