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Results: 1 to 20 of 396

1.

Phase 0 clinical trials: conceptions and misconceptions.

Kummar S, Rubinstein L, Kinders R, Parchment RE, Gutierrez ME, Murgo AJ, Ji J, Mroczkowski B, Pickeral OK, Simpson M, Hollingshead M, Yang SX, Helman L, Wiltrout R, Collins J, Tomaszewski JE, Doroshow JH.

Cancer J. 2008 May-Jun;14(3):133-7. doi: 10.1097/PPO.0b013e318172d6f3. Review.

PMID:
18536551
[PubMed - indexed for MEDLINE]
2.

Phase 0 clinical trials in cancer drug development: from FDA guidance to clinical practice.

Kinders R, Parchment RE, Ji J, Kummar S, Murgo AJ, Gutierrez M, Collins J, Rubinstein L, Pickeral O, Steinberg SM, Yang S, Hollingshead M, Chen A, Helman L, Wiltrout R, Simpson M, Tomaszewski JE, Doroshow JH.

Mol Interv. 2007 Dec;7(6):325-34. doi: 10.1124/mi.7.6.9. Review.

PMID:
18199854
[PubMed - indexed for MEDLINE]
3.

Exploratory IND: a new regulatory strategy for early clinical drug development in the United States.

Sarapa N.

Ernst Schering Res Found Workshop. 2007;(59):151-63. Review.

PMID:
17117721
[PubMed - indexed for MEDLINE]
4.

Phase 0 clinical trials in oncology: a paradigm shift for early drug development?

Takimoto CH.

Cancer Chemother Pharmacol. 2009 Mar;63(4):703-9. doi: 10.1007/s00280-008-0789-4. Epub 2008 Jul 10. Review.

PMID:
18615251
[PubMed - indexed for MEDLINE]
5.

Lessons learned from independent central review.

Ford R, Schwartz L, Dancey J, Dodd LE, Eisenhauer EA, Gwyther S, Rubinstein L, Sargent D, Shankar L, Therasse P, Verweij J.

Eur J Cancer. 2009 Jan;45(2):268-74. doi: 10.1016/j.ejca.2008.10.031.

PMID:
19101138
[PubMed - indexed for MEDLINE]
6.

PhRMA survey on the conduct of first-in-human clinical trials under exploratory investigational new drug applications.

Karara AH, Edeki T, McLeod J, Tonelli AP, Wagner JA.

J Clin Pharmacol. 2010 Apr;50(4):380-91. doi: 10.1177/0091270009344987. Epub 2010 Jan 23.

PMID:
20097935
[PubMed - indexed for MEDLINE]
7.

Current good manufacturing practice and investigational new drugs intended for use in clinical trials. Final rule.

Food and Drug Administration, HHS.

Fed Regist. 2008 Jul 15;73(136):40453-63.

PMID:
18850678
[PubMed - indexed for MEDLINE]
Free Article
8.

Leveraging exploratory investigational new drug studies to accelerate drug development.

Jacobson-Kram D, Mills G.

Clin Cancer Res. 2008 Jun 15;14(12):3670-4. doi: 10.1158/1078-0432.CCR-07-4558.

PMID:
18559581
[PubMed - indexed for MEDLINE]
Free Article
9.

Innovative strategies for early clinical R&D.

Butz RF, Morelli G.

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

PMID:
18175261
[PubMed - indexed for MEDLINE]
10.

Information needed to conduct first-in-human oncology trials in the United States: a view from a former FDA medical reviewer.

Senderowicz AM.

Clin Cancer Res. 2010 Mar 15;16(6):1719-25. doi: 10.1158/1078-0432.CCR-09-2766. Epub 2010 Mar 9.

PMID:
20215544
[PubMed - indexed for MEDLINE]
Free Article
11.

Investigational new drugs submitted to the Food and Drug Administration that are placed on clinical hold: the experience of the Office of Cellular, Tissue and Gene Therapy.

Wonnacott K, Lavoie D, Fiorentino R, McIntyre M, Huang Y, Hirschfeld S.

Cytotherapy. 2008;10(3):312-6. doi: 10.1080/14653240801910905.

PMID:
18418776
[PubMed - indexed for MEDLINE]
12.

Project Zero Delay: a process for accelerating the activation of cancer clinical trials.

Kurzrock R, Pilat S, Bartolazzi M, Sanders D, Van Wart Hood J, Tucker SD, Webster K, Mallamaci MA, Strand S, Babcock E, Bast RC Jr.

J Clin Oncol. 2009 Sep 10;27(26):4433-40. doi: 10.1200/JCO.2008.21.6093. Epub 2009 Aug 3.

PMID:
19652061
[PubMed - indexed for MEDLINE]
13.

Drug research: from the idea to the product.

Kuhlmann J.

Int J Clin Pharmacol Ther. 1997 Dec;35(12):541-52. Review.

PMID:
9455711
[PubMed - indexed for MEDLINE]
14.

Regulatory decision strategy for entry of a novel biological therapeutic with a clinically unmonitorable toxicity into clinical trials: pre-IND meetings and a case example.

Black LE, Bendele AM, Bendele RA, Zack PM, Hamilton M.

Toxicol Pathol. 1999 Jan-Feb;27(1):22-6. Review.

PMID:
10367668
[PubMed - indexed for MEDLINE]
Free Article
15.

Phase 1 clinical trials.

Muglia JJ, DiGiovanna JJ.

J Cutan Med Surg. 1998 Apr;2(4):236-41.

PMID:
9558307
[PubMed - indexed for MEDLINE]
16.

Regulatory considerations for evaluating the pharmacology and toxicology of antisense drugs.

Black LE, Degeorge JJ, Cavagnaro JA, Jordan A, Ahn CH.

Antisense Res Dev. 1993 Winter;3(4):399-404.

PMID:
8155981
[PubMed - indexed for MEDLINE]
18.

The investigator-sponsored IND in clinical trials.

Haakenson C, Fye CL, Sather MR, Toussaint DJ.

Control Clin Trials. 1987 Jun;8(2):101-9.

PMID:
3608504
[PubMed - indexed for MEDLINE]
19.

Oncologic phase 0 trials incorporating clinical pharmacodynamics: from concept to patient.

Doroshow JH, Parchment RE.

Clin Cancer Res. 2008 Jun 15;14(12):3658-63. doi: 10.1158/1078-0432.CCR-07-4562.

PMID:
18559579
[PubMed - indexed for MEDLINE]
Free PMC Article
20.

Unique/major human metabolites: why, how, and when to test for safety in animals.

Luffer-Atlas D.

Drug Metab Rev. 2008;40(3):447-63. doi: 10.1080/03602530802186561 . Review.

PMID:
18642142
[PubMed - indexed for MEDLINE]

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