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Items: 1 to 20 of 49

1.
2.

Innovative strategies for early clinical R&D.

Butz RF, Morelli G.

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

PMID:
18175261
3.

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
4.

Computational toxicology approaches at the US Food and Drug Administration.

Yang C, Valerio LG Jr, Arvidson KB.

Altern Lab Anim. 2009 Nov;37(5):523-31. Review.

PMID:
20017581
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.

FDA critical path initiatives: opportunities for generic drug development.

Lionberger RA.

AAPS J. 2008;10(1):103-9. doi: 10.1208/s12248-008-9010-2. Epub 2008 Feb 20. Review.

7.
8.

Criteria supporting the study of drugs in the newborn.

Ward RM, Benitz WE, Benjamin DK Jr, Blackmon L, Giacoia GP, Hudak M, Lasky T, Rodriguez W, Selen A.

Clin Ther. 2006 Sep;28(9):1385-98. Review.

PMID:
17062311
9.

Patient-reported outcomes supporting anticancer product approvals.

Rock EP, Kennedy DL, Furness MH, Pierce WF, Pazdur R, Burke LB.

J Clin Oncol. 2007 Nov 10;25(32):5094-9. Review.

PMID:
17991927
10.

The identification of benefit in medical intervention: an overview and suggestions for process.

Stang PE, Pham SV, Kinchen K, Raff SB, Mussen F, Gondek K.

Am J Ther. 2008 Sep-Oct;15(5):495-503. doi: 10.1097/MJT.0b013e31816b8fff. Review.

PMID:
18806527
11.

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
12.

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
13.

Does your clinical investigator understand the consequences of non-compliance?

Donato BJ, Gibson TR.

Qual Assur. 1999 Jul-Sep;7(3):135-45. Review.

PMID:
11033739
14.

The drug diagnostic co-development concept paper: commentary from the 3rd FDA-DIA-PWG-PhRMA-BIO Pharmacogenomics Workshop.

Hinman LM, Huang SM, Hackett J, Koch WH, Love PY, Pennello G, Torres-Cabassa A, Webster C.

Pharmacogenomics J. 2006 Nov-Dec;6(6):375-80. Epub 2006 May 2. Review.

PMID:
16652120
15.

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
16.

Drugs and other product choices.

Hyman PM, Carvajal R.

Dermatol Ther. 2009 May-Jun;22(3):216-24. doi: 10.1111/j.1529-8019.2009.01234.x. Review.

PMID:
19453345
17.

Finding, evaluating, and managing drug-related risks: approaches taken by the US Food and Drug Administration (FDA).

Weaver J, Grenade LL, Kwon H, Avigan M.

Dermatol Ther. 2009 May-Jun;22(3):204-15. doi: 10.1111/j.1529-8019.2009.01233.x. Review.

PMID:
19453344
18.

An overview of FDA medical device regulation as it relates to deep brain stimulation devices.

Peña C, Bowsher K, Costello A, De Luca R, Doll S, Li K, Schroeder M, Stevens T.

IEEE Trans Neural Syst Rehabil Eng. 2007 Sep;15(3):421-4. Review.

PMID:
17894274
19.

Risk evaluation and mitigation strategies for drugs with abuse liability: public interest, special interest, conflicts of interest, and the industry perspective.

Wright C 4th, Schnoll S, Bernstein D.

Ann N Y Acad Sci. 2008 Oct;1141:284-303. doi: 10.1196/annals.1441.026. Review.

PMID:
18991964
20.

The FDA's new oncology office.

Pazdur R.

Clin Adv Hematol Oncol. 2005 Aug;3(8):612-3. Review. No abstract available.

PMID:
16167044

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