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Results: 1 to 20 of 37

1.

Integration and use of biomarkers in drug development, regulation and clinical practice: a US regulatory perspective.

Amur S, Frueh FW, Lesko LJ, Huang SM.

Biomark Med. 2008 Jun;2(3):305-11. doi: 10.2217/17520363.2.3.305.

PMID:
20477416
[PubMed]
2.

Food and Drug Administration requirements for testing and approval of new radiopharmaceuticals.

Harapanhalli RS.

Semin Nucl Med. 2010 Sep;40(5):364-84. doi: 10.1053/j.semnuclmed.2010.05.002. Review.

PMID:
20674596
[PubMed - indexed for MEDLINE]
3.

INGN 201: Ad-p53, Ad5CMV-p53, adenoviral p53, p53 gene therapy--introgen, RPR/INGN 201.

[No authors listed]

Drugs R D. 2007;8(3):176-87. Review.

PMID:
17472413
[PubMed - indexed for MEDLINE]
4.

Safety assessment of biotechnology-derived pharmaceuticals: ICH and beyond.

Serabian MA, Pilaro AM.

Toxicol Pathol. 1999 Jan-Feb;27(1):27-31. Review.

PMID:
10367669
[PubMed - indexed for MEDLINE]
Free Article
5.

ISA 247: trans-ISA 247, trans-R 1524, ISA(TX)247, ISAtx 247, ISATx247, LX 211, LX211, R 1524, R-1524.

[No authors listed]

Drugs R D. 2007;8(2):103-12. Review.

PMID:
17324008
[PubMed - indexed for MEDLINE]
6.

Molecular biomarkers: a US FDA effort.

Hong H, Goodsaid F, Shi L, Tong W.

Biomark Med. 2010 Apr;4(2):215-25. doi: 10.2217/bmm.09.81. Review.

PMID:
20406066
[PubMed - indexed for MEDLINE]
7.

Bringing New PET drugs to clinical practice - a regulatory perspective.

Hung JC.

Theranostics. 2013 Nov 1;3(11):885-93. doi: 10.7150/thno.5513. Review.

PMID:
24312157
[PubMed - indexed for MEDLINE]
Free PMC Article
8.

Paving the critical path: how can clinical pharmacology help achieve the vision?

Lesko LJ.

Clin Pharmacol Ther. 2007 Feb;81(2):170-7. Review.

PMID:
17259944
[PubMed - indexed for MEDLINE]
9.

Influenza virus vaccine live intranasal--MedImmune vaccines: CAIV-T, influenza vaccine live intranasal.

[No authors listed]

Drugs R D. 2003;4(5):312-9. Review.

PMID:
12952502
[PubMed - indexed for MEDLINE]
10.

New science-based endpoints to accelerate oncology drug development.

Kelloff GJ, Sigman CC.

Eur J Cancer. 2005 Mar;41(4):491-501. Epub 2005 Jan 22. Review.

PMID:
15737552
[PubMed - indexed for MEDLINE]
11.

Development and use of biomarkers in oncology drug development.

Floyd E, McShane TM.

Toxicol Pathol. 2004 Mar-Apr;32 Suppl 1:106-15. Review.

PMID:
15209410
[PubMed - indexed for MEDLINE]
Free Article
12.

Biomarkers in drug discovery and development: from target identification through drug marketing.

Colburn WA.

J Clin Pharmacol. 2003 Apr;43(4):329-41. Review.

PMID:
12723454
[PubMed - indexed for MEDLINE]
13.

Patient use of dietary supplements: a clinician's perspective.

Sadovsky R, Collins N, Tighe AP, Brunton SA, Safeer R.

Curr Med Res Opin. 2008 Apr;24(4):1209-16. doi: 10.1185/030079908X280743 . Epub 2008 Mar 17. Review.

PMID:
18348745
[PubMed - indexed for MEDLINE]
14.

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
[PubMed - indexed for MEDLINE]
15.

[Development of antituberculous drugs: current status and future prospects].

Tomioka H, Namba K.

Kekkaku. 2006 Dec;81(12):753-74. Review. Japanese.

PMID:
17240921
[PubMed - indexed for MEDLINE]
16.

The discovery and development of proteomic safety biomarkers for the detection of drug-induced liver toxicity.

Amacher DE.

Toxicol Appl Pharmacol. 2010 May 15;245(1):134-42. doi: 10.1016/j.taap.2010.02.011. Epub 2010 Feb 26. Review.

PMID:
20219512
[PubMed - indexed for MEDLINE]
17.

Integration of pharmacogenetics and pharmacogenomics in drug development: implications for regulatory and medical decision making in pediatric diseases.

Piana C, Surh L, Furst-Recktenwald S, Iolascon A, Jacqz-Aigrain EM, Jonker I, Russo R, van Schaik RH, Wessels J, Della Pasqua OE.

J Clin Pharmacol. 2012 May;52(5):704-16. doi: 10.1177/0091270011401619. Epub 2011 May 12. Review.

PMID:
21566202
[PubMed - indexed for MEDLINE]
18.

Using exposure-response and biomarkers to streamline early drug development.

Venitz J.

Ernst Schering Res Found Workshop. 2007;(59):47-63. Review.

PMID:
17117714
[PubMed - indexed for MEDLINE]
19.

Faropenem medoxomil: A0026, BAY 56-6854, BAY 566854, faropenem daloxate, SUN 208, SUN A0026.

[No authors listed]

Drugs R D. 2008;9(2):115-24. Review.

PMID:
18298129
[PubMed - indexed for MEDLINE]
20.

Trabectedin: Ecteinascidin 743, Ecteinascidin-743, ET 743, ET-743, NSC 684766.

[No authors listed]

Drugs R D. 2006;7(5):317-28. Review.

PMID:
16922593
[PubMed - indexed for MEDLINE]
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