메뉴 건너뛰기




Volumn 81, Issue 2, 2007, Pages 141-144

Medical product development and regulatory science for the 21st century: The critical path vision and its impact on health care

Author keywords

[No Author keywords available]

Indexed keywords

IRINOTECAN; TAMOXIFEN; WARFARIN;

EID: 33846583582     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/sj.clpt.6100085     Document Type: Editorial
Times cited : (34)

References (17)
  • 1
    • 33846589677 scopus 로고    scopus 로고
    • Food and Drug Administration. FDA Critical Path Initiatives white paper: innovation or stagnation? Challenge and opportunity on the critical path to new medical products 〈http://www.fda.gov/oc/initiatives/criticalpath/ whitepaper.html〉 (March 2004). Accessed 6 October 2006.
    • Food and Drug Administration. FDA Critical Path Initiatives white paper: innovation or stagnation? Challenge and opportunity on the critical path to new medical products 〈http://www.fda.gov/oc/initiatives/criticalpath/ whitepaper.html〉 (March 2004). Accessed 6 October 2006.
  • 2
    • 33846631232 scopus 로고    scopus 로고
    • Food and Drug Administration. FDA Critical Path Opportunity Report and List 〈http://www.fda.gov/oc/initiatives/criticalpath/reports/opp_report. pdf〉 and 〈http://www.fda.gov/oc/initiatives/criticalpath/reports/ opp_list.pdf〉 (March 2006). Accessed 20 November 2006.
    • Food and Drug Administration. FDA Critical Path Opportunity Report and List 〈http://www.fda.gov/oc/initiatives/criticalpath/reports/opp_report. pdf〉 and 〈http://www.fda.gov/oc/initiatives/criticalpath/reports/ opp_list.pdf〉 (March 2006). Accessed 20 November 2006.
  • 3
    • 33846647567 scopus 로고    scopus 로고
    • Gardasil®: Prophylactic human papillomavirus vaccine development-from bench top to bed side
    • Shi, L. et al. Gardasil®: prophylactic human papillomavirus vaccine development-from bench top to bed side. Clin. Pharmacol. Ther. 81, 259-264 (2007).
    • (2007) Clin. Pharmacol. Ther , vol.81 , pp. 259-264
    • Shi, L.1
  • 4
    • 33846646004 scopus 로고    scopus 로고
    • The prospect for "personalized medicine" in drug development and drug therapy
    • Woodcock, J. The prospect for "personalized medicine" in drug development and drug therapy. Clin. Pharmacol. Ther. 81, 164-169 (2007).
    • (2007) Clin. Pharmacol. Ther , vol.81 , pp. 164-169
    • Woodcock, J.1
  • 5
    • 33846600536 scopus 로고    scopus 로고
    • Management of atrial fibrillation in symptomatic elderly patients: Pharmacologic therapy versus AV node ablation
    • Shen, W.K. & Bradley, D.J. Management of atrial fibrillation in symptomatic elderly patients: pharmacologic therapy versus AV node ablation. Clin. Pharmacol. Ther. 81, 284-287 (2007).
    • (2007) Clin. Pharmacol. Ther , vol.81 , pp. 284-287
    • Shen, W.K.1    Bradley, D.J.2
  • 6
    • 33846620242 scopus 로고    scopus 로고
    • The experience with voluntary genomic data submissions at the FDA and a vision for the future of the voluntary data submission program
    • Orr, M.S., Goodsaid, F., Amur, S., Rudman, A. & Frueh, F.W. The experience with voluntary genomic data submissions at the FDA and a vision for the future of the voluntary data submission program. Clin. Pharmacol. Ther. 81, 294-297 (2007).
    • (2007) Clin. Pharmacol. Ther , vol.81 , pp. 294-297
    • Orr, M.S.1    Goodsaid, F.2    Amur, S.3    Rudman, A.4    Frueh, F.W.5
  • 7
    • 33846577441 scopus 로고    scopus 로고
    • Drug interaction studies-study design, data analysis and implications for dosing and labeling
    • Huang, S.M., Temple, R., Throckmorton, D. & Lesko, L.J. Drug interaction studies-study design, data analysis and implications for dosing and labeling. Clin. Pharmacol. Ther. 81, 298-304 (2007).
    • (2007) Clin. Pharmacol. Ther , vol.81 , pp. 298-304
    • Huang, S.M.1    Temple, R.2    Throckmorton, D.3    Lesko, L.J.4
  • 8
    • 33846607427 scopus 로고    scopus 로고
    • Appropriate phenotyping procedures for drug metabolizing enzymes and transporters in humans and their simultaneous use in the "cocktail" approach
    • Fuhr, U., Jetter, A. & Kirchheiner, J. Appropriate phenotyping procedures for drug metabolizing enzymes and transporters in humans and their simultaneous use in the "cocktail" approach. Clin. Pharmacol. Ther. 81, 270-283 (2007).
    • (2007) Clin. Pharmacol. Ther , vol.81 , pp. 270-283
    • Fuhr, U.1    Jetter, A.2    Kirchheiner, J.3
  • 9
    • 33846614930 scopus 로고    scopus 로고
    • Food and Drug Administration. FDA Guidance Page. Draft Guidance for Industry: Drug Interaction Studies-Study Design, Data Analysis, and Implications for Dosing and Labeling 〈http://www.fda.gov/cder/guidance/6695dft. pdf〉 (2006). Accessed 20 November 2006.
    • Food and Drug Administration. FDA Guidance Page. Draft Guidance for Industry: Drug Interaction Studies-Study Design, Data Analysis, and Implications for Dosing and Labeling 〈http://www.fda.gov/cder/guidance/6695dft. pdf〉 (2006). Accessed 20 November 2006.
  • 10
    • 33846604099 scopus 로고    scopus 로고
    • Food and Drug Administration, Advisory Committee on Pharmaceutical Science, 3-4 November, Accessed 20 November 2006
    • Food and Drug Administration, Advisory Committee on Pharmaceutical Science. Report on Clinical Pharmacology Subcommittee meeting, 3-4 November, 2004 〈http://www.fda.gov/ohrms/dockets/ac/04/briefing/2004-4079b1.htm〉 (2004). Accessed 20 November 2006.
    • (2004) Report on Clinical Pharmacology Subcommittee meeting
  • 11
    • 33846580908 scopus 로고    scopus 로고
    • Food and Drug Administration, Advisory Committee on Pharmaceutical Science, 14-15 November, Accessed 20 November 2006
    • Food and Drug Administration, Advisory Committee on Pharmaceutical Science. Report on Clinical Pharmacology Subcommittee meeting, 14-15 November 2005 〈http://www.fda.gov/ohrms/dockets/ac/cder05.html#PharmScience〉 (2005). Accessed 20 November 2006.
    • (2005) Report on Clinical Pharmacology Subcommittee meeting
  • 12
    • 33846577684 scopus 로고    scopus 로고
    • Food and Drug Administration, Advisory Committee on Pharmaceutical Science, 18-19 October, Accessed 20 November 2006
    • Food and Drug Administration, Advisory Committee on Pharmaceutical Science. Report on Clinical Pharmacology Subcommittee Meeting, 18-19 October 2006. 〈http://www.fda.gov/ohrms/dockets/ac/cder06.html#PharmScience〉 (2006). Accessed 20 November 2006.
    • (2006) Report on Clinical Pharmacology Subcommittee Meeting
  • 13
    • 28844491802 scopus 로고    scopus 로고
    • Drug-metabolizing enzymes-clinical utility of pharmacogenomic test
    • Andersson, T. et al. Drug-metabolizing enzymes-clinical utility of pharmacogenomic test. Clin. Pharmacol. Ther. 78, 559-581 (2005).
    • (2005) Clin. Pharmacol. Ther , vol.78 , pp. 559-581
    • Andersson, T.1
  • 14
    • 33846635128 scopus 로고    scopus 로고
    • Distinguishing product and practice regulation in personalized medicine
    • Evans, B.J. Distinguishing product and practice regulation in personalized medicine. Clin. Pharmacol. Ther. 81, 288-293 (2007).
    • (2007) Clin. Pharmacol. Ther , vol.81 , pp. 288-293
    • Evans, B.J.1
  • 15
    • 33846568546 scopus 로고    scopus 로고
    • ABCB1 pharmacogenetics: Progress, pitfalls and promise
    • Chinn, L.S. & Kroetz, D.L. ABCB1 pharmacogenetics: progress, pitfalls and promise. Clin. Pharmacol. Ther. 81, 265-269 (2007).
    • (2007) Clin. Pharmacol. Ther , vol.81 , pp. 265-269
    • Chinn, L.S.1    Kroetz, D.L.2
  • 16
    • 33846600867 scopus 로고    scopus 로고
    • Paving the critical path: How can clinical pharmacology help achieve the vision?
    • Lesko, L.J. Paving the critical path: how can clinical pharmacology help achieve the vision? Clin. Pharmacol. Ther. 81, 170-177 (2007).
    • (2007) Clin. Pharmacol. Ther , vol.81 , pp. 170-177
    • Lesko, L.J.1
  • 17
    • 33846612863 scopus 로고    scopus 로고
    • Clinical pharmacology education: Looking into the future
    • Gray, J., Danoff, D. & Shepherd, A. Clinical pharmacology education: looking into the future. Clin. Pharmacol. Ther. 81, 305-308 (2007).
    • (2007) Clin. Pharmacol. Ther , vol.81 , pp. 305-308
    • Gray, J.1    Danoff, D.2    Shepherd, A.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.