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Items: 1 to 20 of 30

1.

The International Transporter Consortium: a collaborative group of scientists from academia, industry, and the FDA.

Huang SM, Zhang L, Giacomini KM.

Clin Pharmacol Ther. 2010 Jan;87(1):32-6. doi: 10.1038/clpt.2009.236.

PMID:
20019700
2.

The Critical Path Institute's approach to precompetitive sharing and advancing regulatory science.

Woosley RL, Myers RT, Goodsaid F.

Clin Pharmacol Ther. 2010 May;87(5):530-3. doi: 10.1038/clpt.2010.27. Review.

PMID:
20407457
3.

Pharmacological mechanism-based drug safety assessment and prediction.

Abernethy DR, Woodcock J, Lesko LJ.

Clin Pharmacol Ther. 2011 Jun;89(6):793-7. doi: 10.1038/clpt.2011.55. Epub 2011 Apr 13. Review.

PMID:
21490594
4.

The FDA critical path initiative and its influence on new drug development.

Woodcock J, Woosley R.

Annu Rev Med. 2008;59:1-12. doi: 10.1146/annurev.med.59.090506.155819. Review.

PMID:
18186700
5.

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
6.

[Diagnostic kits in parasitology: which controls?].

Rossi P.

Parassitologia. 2004 Jun;46(1-2):145-9. Review. Italian.

PMID:
15305705
7.

Clinical utility of the Food and Drug Administration Electrocardiogram Warehouse: a paradigm for the critical pathway initiative.

Cabell CH, Noto TC, Krucoff MW.

J Electrocardiol. 2005 Oct;38(4 Suppl):175-9. Review.

PMID:
16226096
8.

Biochemical markers and the FDA Critical Path: how biomarkers may contribute to the understanding of pathophysiology and provide unique and necessary tools for drug development.

Karsdal MA, Henriksen K, Leeming DJ, Mitchell P, Duffin K, Barascuk N, Klickstein L, Aggarwal P, Nemirovskiy O, Byrjalsen I, Qvist P, Bay-Jensen AC, Dam EB, Madsen SH, Christiansen C.

Biomarkers. 2009 May;14(3):181-202. doi: 10.1080/13547500902777608. Review.

PMID:
19399662
9.

The importance of new companies for drug discovery: origins of a decade of new drugs.

Kneller R.

Nat Rev Drug Discov. 2010 Nov;9(11):867-82. doi: 10.1038/nrd3251. Epub 2010 Oct 29. Review. Erratum in: Nat Rev Drug Discov. 2010 Dec;9(12):955.

PMID:
21031002
10.

The effect of globalization of drug manufacturing, production, and sourcing and challenges for American drug safety.

Woo J, Wolfgang S, Batista H.

Clin Pharmacol Ther. 2008 Mar;83(3):494-7. doi: 10.1038/sj.clpt.6100493. Epub 2008 Feb 6. Review.

PMID:
18253142
11.

Innovative strategies for early clinical R&D.

Butz RF, Morelli G.

IDrugs. 2008 Jan;11(1):36-41. Review.

PMID:
18175261
12.

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
13.

The safety assessment process--setting the scene: an FDA perspective.

Schechtman LM.

ILAR J. 2002;43 Suppl:S5-10. Review.

14.

New era in drug interaction evaluation: US Food and Drug Administration update on CYP enzymes, transporters, and the guidance process.

Huang SM, Strong JM, Zhang L, Reynolds KS, Nallani S, Temple R, Abraham S, Habet SA, Baweja RK, Burckart GJ, Chung S, Colangelo P, Frucht D, Green MD, Hepp P, Karnaukhova E, Ko HS, Lee JI, Marroum PJ, Norden JM, Qiu W, Rahman A, Sobel S, Stifano T, Thummel K, Wei XX, Yasuda S, Zheng JH, Zhao H, Lesko LJ.

J Clin Pharmacol. 2008 Jun;48(6):662-70. doi: 10.1177/0091270007312153. Epub 2008 Mar 31. Review.

PMID:
18378963
15.
16.

Innovative early development regulatory approaches: expIND, expCTA, microdosing.

Robinson WT.

Clin Pharmacol Ther. 2008 Feb;83(2):358-60. Epub 2007 Dec 19. Review.

PMID:
18091759
17.

Statistical efficiencies that the FDA should encourage.

Overall JE.

Psychopharmacol Bull. 1991;27(3):211-6. Review.

PMID:
1775590
18.

The future of pediatric psychopharmacology.

Walkup JT, Cruz K, Kane S, Geller B.

Pediatr Clin North Am. 1998 Oct;45(5):1265-78. Review.

PMID:
9884685
19.

The status of eye irritancy testing: a regulatory perspective.

Wilcox NL.

Lens Eye Toxic Res. 1992;9(3-4):259-71. Review.

PMID:
1301785
20.

Selected Proceedings of the NICHD/FDA newborn drug development initiative: Part II.

Giacoia GP, Mattison DR.

Clin Ther. 2006 Sep;28(9):1337-41. Review.

PMID:
17062307
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