-
1
-
-
33846589677
-
-
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
-
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
-
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
-
-
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
-
-
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
-
-
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
-
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
-
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
-
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
-
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
-
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
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