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Volumn 22, Issue 1, 2009, Pages 30-38

Promoting, improving and accelerating the drug development and approval processes

(1)  Graul, Ann I a  

a NONE

Author keywords

[No Author keywords available]

Indexed keywords

AMRUBICIN; AZACITIDINE; BECLOMETASONE DIPROPIONATE; BUPIVACAINE; CARBON MONOXIDE; CATUMAXOMAB; CLOBAZAM; CLONAZEPAM; COLISTIMETHATE; DIMETHYL SULFOXIDE; EVEROLIMUS; FLUOXETINE; LENALIDOMIDE; LUMILIXIMAB; MELPHALAN; MEPOLIZUMAB; MIGLUSTAT; NIMOTUZUMAB; OBLIMERSEN; ORPHAN DRUG; PRALATREXATE; PRAMIPEXOLE; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; RESVERATROL; SARSASAPOGENIN; TERGURIDE; TETRATHIOMOLYBDATE AMMONIUM; TRABECTEDIN; UNINDEXED DRUG; VINCRISTINE;

EID: 62649091286     PISSN: 02140934     EISSN: None     Source Type: Journal    
DOI: 10.1358/dnp.2009.22.1.1303816     Document Type: Article
Times cited : (5)

References (31)
  • 2
    • 41149091683 scopus 로고    scopus 로고
    • Promoting, improving and accelerating the drug development and approval processes
    • Graul, A.I. Promoting, improving and accelerating the drug development and approval processes. Drug News Perspect 2008, 21(1): 36-43.
    • (2008) Drug News Perspect , vol.21 , Issue.1 , pp. 36-43
    • Graul, A.I.1
  • 3
    • 62649135209 scopus 로고    scopus 로고
    • FDA Office of Orphan Products Development, May 16, 2008, Accessed November 5, 2008
    • FDA Office of Orphan Products Development. Cumulative list of all orphan designated and or approved products. May 16, 2008. http://www.fda.gov/orphan/designat/alldes.rtf. Accessed November 5, 2008.
    • Cumulative list of all orphan designated and or approved products
  • 4
    • 62649089698 scopus 로고    scopus 로고
    • FDA Office of Orphan Products Development, May 15, 2008, Accessed November 5, 2008
    • FDA Office of Orphan Products Development. Cumulative list of designated approved orphan products. May 15, 2008. http://www.fda.gov/orphan/designat/allap.rtf. Accessed November 5, 2008.
    • Cumulative list of designated approved orphan products
  • 5
    • 41149104007 scopus 로고    scopus 로고
    • List of marketing authorised orphan drugs in Europe
    • July 2008, Accessed November 5
    • Orphanet Reports Series. List of marketing authorised orphan drugs in Europe. July 2008. http://www.orpha.net/orphacom/cahiers/docs/GB/ List_of_marketing_orphan_drugs_in_Europe.pdf. Accessed November 5, 2008.
    • (2008) Orphanet Reports Series
  • 7
    • 62649118758 scopus 로고    scopus 로고
    • Finding value in the U.S. Food and Drug Administration's Fast Track program
    • Reichert, J.M., Rochon, S.L. and Zhang B.D. Finding value in the U.S. Food and Drug Administration's Fast Track program. Drug News Perspect 2009, 22(1): 61-66.
    • (2009) Drug News Perspect , vol.22 , Issue.1 , pp. 61-66
    • Reichert, J.M.1    Rochon, S.L.2    Zhang, B.D.3
  • 8
    • 52449092892 scopus 로고    scopus 로고
    • Oncologic phase 0 trials incorporating clinical pharmacodynamics: From concept to patient
    • Doroshow, J.H. and Parchment, R.E. Oncologic phase 0 trials incorporating clinical pharmacodynamics: From concept to patient. Clin Cancer Res 2008, 14(12): 3658-63.
    • (2008) Clin Cancer Res , vol.14 , Issue.12 , pp. 3658-3663
    • Doroshow, J.H.1    Parchment, R.E.2
  • 9
    • 62649109848 scopus 로고    scopus 로고
    • Guidance for Industry, Investigators and Reviewers: Exploratory IND Studies. Center for Drug Evaluation and Research/U.S. FDA, January 2006. http://www.fda.gov/cder/guidance/7086fnl.pdf. Accessed November 12, 2008.
    • Guidance for Industry, Investigators and Reviewers: Exploratory IND Studies. Center for Drug Evaluation and Research/U.S. FDA, January 2006. http://www.fda.gov/cder/guidance/7086fnl.pdf. Accessed November 12, 2008.
  • 10
    • 38349059980 scopus 로고    scopus 로고
    • Phase 0 clinical trials in cancer drug development: From FDA guidance to cfinicof practice
    • Kinders, R., Parchment, R.E., Ji, J. et al. Phase 0 clinical trials in cancer drug development: From FDA guidance to cfinicof practice. Mol Interv 2007, 7(6): 325-34.
    • (2007) Mol Interv , vol.7 , Issue.6 , pp. 325-334
    • Kinders, R.1    Parchment, R.E.2    Ji, J.3
  • 12
    • 52449091099 scopus 로고    scopus 로고
    • Designing phase 0 cancer clinical trials
    • Murgo, A.J., Kummar, S., Rubinstein, L. et al. Designing phase 0 cancer clinical trials. Clin Cancer Res 2008, 14(12): 3675-82.
    • (2008) Clin Cancer Res , vol.14 , Issue.12 , pp. 3675-3682
    • Murgo, A.J.1    Kummar, S.2    Rubinstein, L.3
  • 13
    • 52649181124 scopus 로고    scopus 로고
    • Phase 0 clinical trials: Conceptions and misconceptions
    • Kummar, S., Rubinstein, L., Kinders, R. et al. Phase 0 clinical trials: Conceptions and misconceptions. Cancer J 2008, 14(3): 133-7.
    • (2008) Cancer J , vol.14 , Issue.3 , pp. 133-137
    • Kummar, S.1    Rubinstein, L.2    Kinders, R.3
  • 14
    • 62649148842 scopus 로고    scopus 로고
    • Xceleron Microclosing Webinar, July 10, 2008. Available at http://www.xceteron.com/metadot/index.pl?iid=2761. Accessed November 17, 2008.
    • Xceleron Microclosing Webinar, July 10, 2008. Available at http://www.xceteron.com/metadot/index.pl?iid=2761. Accessed November 17, 2008.
  • 16
    • 47549118762 scopus 로고    scopus 로고
    • Inhibition of poly (ADP-ribose) polymerose (PARP) by ABT-888 in patients with advanced malignancies: Results of a phase 0 trial
    • Abst 3518
    • Kummar, S. et al. Inhibition of poly (ADP-ribose) polymerose (PARP) by ABT-888 in patients with advanced malignancies: Results of a phase 0 trial. J Clin Oncol 2007, 25(18, Suppl.): Abst 3518.
    • (2007) J Clin Oncol , vol.25 , Issue.18 and SUPPL.
    • Kummar, S.1
  • 17
    • 56349138289 scopus 로고    scopus 로고
    • Using microdosing to enhance development - Early availability of PK information allows for selection of potentially promising molecules
    • Available at, Accessed November 17, 2008
    • Johnson, G. Using microdosing to enhance development - Early availability of PK information allows for selection of potentially promising molecules. Genetic Engineering Biotechnology News, 2008, 28(19). Available at http://www.genengnews.com/articles/ chtitem.aspx?tid=2670. Accessed November 17, 2008.
    • (2008) Genetic Engineering Biotechnology News , vol.28 , Issue.19
    • Johnson, G.1
  • 18
    • 62649138180 scopus 로고    scopus 로고
    • New data further strengthens case for microdosing in drug development, June 19, 2008. Available at, Accessed November 17, 2008
    • New data further strengthens case for microdosing in drug development. Xceleron news release, June 19, 2008. Available at http://www.xceleron.com/metadot/index.pl?id=2754&isa= DBRow&op=show&dbview_id=2596. Accessed November 17, 2008.
    • Xceleron news release
  • 19
    • 62649159430 scopus 로고    scopus 로고
    • 14C Labeling of Biologics. November 12, 2008 ' Available at http://www.xceleron.com/metadot/ index.pl?id=2790&isa=Category&op=show. Accessed November 17, 2008.
    • 14C Labeling of Biologics. November 12, 2008 ' Available at http://www.xceleron.com/metadot/ index.pl?id=2790&isa=Category&op=show. Accessed November 17, 2008.
  • 20
    • 36849015815 scopus 로고    scopus 로고
    • Ethics at phase 0: Clarifying the issues
    • Kimmelman, J. Ethics at phase 0: Clarifying the issues. J Law Med Ethics 2007, 35(4): 727-33.
    • (2007) J Law Med Ethics , vol.35 , Issue.4 , pp. 727-733
    • Kimmelman, J.1
  • 21
    • 52449090857 scopus 로고    scopus 로고
    • The ethics of phase 0 oncology trials
    • Abdoler, E., Taylor, H., Wendler, D. The ethics of phase 0 oncology trials. Clin Cancer Res 2008, 14(12): 3692-7.
    • (2008) Clin Cancer Res , vol.14 , Issue.12 , pp. 3692-3697
    • Abdoler, E.1    Taylor, H.2    Wendler, D.3
  • 22
    • 62649164259 scopus 로고    scopus 로고
    • Pharmaceutical quality for the 27st century: A risk-based approach
    • Department of Health and Human Services/U.S. Food and Drug Administration, May 2007. Available at, Accessed November 17
    • Department of Health and Human Services/U.S. Food and Drug Administration. Pharmaceutical quality for the 27st century: A risk-based approach. Progress report. May 2007. Available at http://www.fda.gov/oc/cgmp/report0507.html. Accessed November 17, 2008.
    • (2008) Progress report
  • 23
    • 43349088601 scopus 로고    scopus 로고
    • Pharmaceutical quality by design: Product and process development, understanding, and control
    • Yu, L.X. Pharmaceutical quality by design: Product and process development, understanding, and control. Pharmaceut Res 2008, 25(4): 781-91.
    • (2008) Pharmaceut Res , vol.25 , Issue.4 , pp. 781-791
    • Yu, L.X.1
  • 26
    • 0037157590 scopus 로고    scopus 로고
    • Drug development for neglected diseases: A deficient market and a public-health policy failure
    • Trouiller, P., Olliaro, P., TorreeLe, E., Orbinski, J., Laing, R. and Ford, N. Drug development for neglected diseases: A deficient market and a public-health policy failure. Lancet 2002, 359(9339): 1102.
    • (2002) Lancet , vol.359 , Issue.9339 , pp. 1102
    • Trouiller, P.1    Olliaro, P.2    TorreeLe, E.3    Orbinski, J.4    Laing, R.5    Ford, N.6
  • 27
    • 62649160466 scopus 로고    scopus 로고
    • Guidance for industry: Tropical disease priority review vouchers
    • U.S. Department of Health and Human Services/Food and Drug Administration/Center for Drug Evaluation and Research/Center for Biologics Evaluation and Research, October, Available at, Accessed December 12, 2008
    • U.S. Department of Health and Human Services/Food and Drug Administration/Center for Drug Evaluation and Research/Center for Biologics Evaluation and Research. Guidance for industry: Tropical disease priority review vouchers. Draft guidance (October 2008). Available at http://www.fda.gov/OHRMS/DOCKETS/98fr/ FDA-2008-D-0530-gdL.pdf. Accessed December 12, 2008.
    • (2008) Draft guidance
  • 28
    • 57349151132 scopus 로고    scopus 로고
    • Drug development for neglected diseases - The trouble with FDA review vouchers
    • Kesselheim, A.S. Drug development for neglected diseases - The trouble with FDA review vouchers. N Engl J Med 2008, 359(19): 1981-3.
    • (2008) N Engl J Med , vol.359 , Issue.19 , pp. 1981-1983
    • Kesselheim, A.S.1
  • 29
    • 33645680700 scopus 로고    scopus 로고
    • Developing drugs for developing countries
    • Ridley, D.B., Grabowski, H.G. and Moe, J.L. Developing drugs for developing countries. Health Affairs 2006, 25(2): 313-24.
    • (2006) Health Affairs , vol.25 , Issue.2 , pp. 313-324
    • Ridley, D.B.1    Grabowski, H.G.2    Moe, J.L.3
  • 30
    • 62649159964 scopus 로고    scopus 로고
    • US FDA priority review vouchers: An effective incentive to develop drugs and vaccines for neglected diseases? International AIDS Vaccine Initiative (IAVI) technical note (2008). Available at https://www.iavi.org/viewfile.cfm?fid=4796. Accessed December 12, 2008.
    • US FDA priority review vouchers: An effective incentive to develop drugs and vaccines for neglected diseases? International AIDS Vaccine Initiative (IAVI) technical note (2008). Available at https://www.iavi.org/viewfile.cfm?fid=4796. Accessed December 12, 2008.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.