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Items: 1 to 20 of 108

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.

Executive Summary of the National Cancer Institute Workshop: Highlights and recommendations.

Lieberman R, Nelson WG, Sakr WA, Meyskens FL Jr, Klein EA, Wilding G, Partin AW, Lee JJ, Lippman SM.

Urology. 2001 Apr;57(4 Suppl 1):4-27.

PMID:
11295590
7.

[Diagnostic kits in parasitology: which controls?].

Rossi P.

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

PMID:
15305705
8.

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
9.

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
10.

Is it possible for FDA regulatory scientists and industry scientists to work together?

Woosley RL.

Clin Pharmacol Ther. 2012 Mar;91(3):390-2. doi: 10.1038/clpt.2011.304.

PMID:
22343817
11.

The critical path initiative: leveraging collaborations to enhance regulatory science.

Barratt RA, Bowens SL, McCune SK, Johannessen JN, Buckman SY.

Clin Pharmacol Ther. 2012 Mar;91(3):380-3. doi: 10.1038/clpt.2011.318.

PMID:
22343813
12.

Should biochemical markers of bone turnover be considered standard practice for safety pharmacology?

Henriksen K, Bohren KM, Bay-Jensen AC, Karsdal MA.

Biomarkers. 2010 May;15(3):195-204. doi: 10.3109/13547500903434519.

PMID:
19951005
13.

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
14.

Scientists focus on pharmacogenomics at FDA Science Forum.

Young D.

Am J Health Syst Pharm. 2005 Jun 15;62(12):1226. No abstract available.

PMID:
15947120
15.

Microarray data--the US FDA, industry and academia.

Hackett JL, Lesko LJ.

Nat Biotechnol. 2003 Jul;21(7):742-3. No abstract available.

PMID:
12833089
16.

Pharmaceutical industry in pediatric drug development: partners and collaborators with academia and the FDA.

Mulberg AE.

J Pediatr Gastroenterol Nutr. 2008 Nov;47(5):711-3. doi: 10.1097/01.mpg.0000338970.57088.89. No abstract available.

PMID:
18955888
17.

Vision and will: the future of the FDA.

Epstein D.

Oncologist. 2009 Apr;14(4):317-9. doi: 10.1634/theoncologist.2009-0053. Epub 2009 Apr 13. No abstract available.

18.

Preparing for an FDA preapproval inspection.

Blackmer RA.

Qual Assur. 1994 Dec;3(4):389-403.

PMID:
7613749
19.

Paul Brown. Interview by Asher Mullard.

Brown P.

Nat Rev Drug Discov. 2011 Sep 30;10(10):726. doi: 10.1038/nrd3575. No abstract available.

PMID:
21959279
20.

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