Format
Items per page
Sort by

Send to:

Choose Destination

Results: 1 to 20 of 84

Related Articles by Review for PubMed (Select 18091762)

1.

A prototypical process for creating evidentiary standards for biomarkers and diagnostics.

Altar CA, Amakye D, Bounos D, Bloom J, Clack G, Dean R, Devanarayan V, Fu D, Furlong S, Hinman L, Girman C, Lathia C, Lesko L, Madani S, Mayne J, Meyer J, Raunig D, Sager P, Williams SA, Wong P, Zerba K.

Clin Pharmacol Ther. 2008 Feb;83(2):368-71. Epub 2007 Dec 19.

PMID:
18091762
2.

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
3.

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
4.

A systematic approach to preclinical and clinical safety biomarker qualification incorporating Bradford Hill's principles of causality association.

Chetty RK, Ozer JS, Lanevschi A, Schuppe-Koistinen I, McHale D, Pears JS, Vonderscher J, Sistare FD, Dieterle F.

Clin Pharmacol Ther. 2010 Aug;88(2):260-2. doi: 10.1038/clpt.2010.77. Epub 2010 Jun 30. Review. No abstract available.

PMID:
20592723
5.

Promises of biomarkers in drug development--a reality check.

Marrer E, Dieterle F.

Chem Biol Drug Des. 2007 Jun;69(6):381-94. Review.

PMID:
17581232
6.

The applications of biomarkers in early clinical drug development to improve decision-making processes.

Kuhlmann J.

Ernst Schering Res Found Workshop. 2007;(59):29-45. Review.

PMID:
17117713
7.

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
8.

Process and product development in the manufacturing of molecular therapeutics.

Atkinson EM, Christensen JR.

Curr Opin Mol Ther. 1999 Aug;1(4):422-9. Review.

PMID:
11713755
9.

Assessing the clinical utility of diagnostics used in drug therapy.

Woodcock J.

Clin Pharmacol Ther. 2010 Dec;88(6):765-73. doi: 10.1038/clpt.2010.230. Epub 2010 Oct 27. Review.

PMID:
20981005
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.

A cost-effectiveness approach to the qualification and acceptance of biomarkers.

Williams SA, Slavin DE, Wagner JA, Webster CJ.

Nat Rev Drug Discov. 2006 Nov;5(11):897-902. Review.

PMID:
17080026
12.

Drug metabolites in safety testing.

Baillie TA, Cayen MN, Fouda H, Gerson RJ, Green JD, Grossman SJ, Klunk LJ, LeBlanc B, Perkins DG, Shipley LA.

Toxicol Appl Pharmacol. 2002 Aug 1;182(3):188-96. Review.

PMID:
12229863
13.

Innovative approaches in drug development.

Chang M, Kenley S, Bull J, Chiu YY, Wang W, Wakeford C, McCarthy K.

J Biopharm Stat. 2007;17(5):775-89. Review.

PMID:
17885865
14.

Biomarker method validation in anticancer drug development.

Cummings J, Ward TH, Greystoke A, Ranson M, Dive C.

Br J Pharmacol. 2008 Feb;153(4):646-56. Epub 2007 Sep 17. Review.

15.

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
16.

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
17.

Innovative strategies for early clinical R&D.

Butz RF, Morelli G.

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

PMID:
18175261
18.

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
19.

Biomarkers in clinical drug development.

Gobburu JV.

Clin Pharmacol Ther. 2009 Jul;86(1):26-7. doi: 10.1038/clpt.2009.57. Review.

PMID:
19536121
20.

Development and standardisation of DNA vaccines.

Cichutek K.

Dev Biol Stand. 1999;100:119-29. Review. No abstract available.

PMID:
10616182
Format
Items per page
Sort by

Send to:

Choose Destination

Supplemental Content

Write to the Help Desk