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Volumn 82, Issue 1, 2007, Pages 12-14

"Getting the dose right": Facts, a blueprint, and encouragements

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL PHARMACOLOGY; DRUG SAFETY; GENETICS; GOVERNMENT REGULATION; HUMAN; LEADERSHIP; MEDICINE; PHARMACOGENETICS; PHYSICIAN; POPULATION; PRESCRIPTION; PRIORITY JOURNAL; SHORT SURVEY;

EID: 34250658781     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/sj.clpt.6100215     Document Type: Short Survey
Times cited : (28)

References (20)
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    • Peck, C.C. et al. Opportunities for integration of pharmacokinetics, pharmacodynamics, and toxicokinetics in rational drug development. Clin. Pharmacol. Ther. 51, 465-473 (1992).
    • (1992) Clin. Pharmacol. Ther , vol.51 , pp. 465-473
    • Peck, C.C.1
  • 4
    • 0031003468 scopus 로고    scopus 로고
    • Learning versus confirming in clinical drug development
    • Sheiner, L.B. Learning versus confirming in clinical drug development. Clin. Pharmacol. Ther. 61, 275-291 (1997).
    • (1997) Clin. Pharmacol. Ther , vol.61 , pp. 275-291
    • Sheiner, L.B.1
  • 5
    • 34250651002 scopus 로고    scopus 로고
    • Food and Drug Administration Modernization Act of
    • Food and Drug Administration Modernization Act of 1997. Public Law. (1997).
    • (1997) Public Law
  • 6
    • 0037534027 scopus 로고    scopus 로고
    • Hypothesis: A single clinical trial plus causal evidence of effectiveness is sufficient for drug approval
    • Peck, C.C., Rubin, D.B. & Sheiner, L.B. Hypothesis: a single clinical trial plus causal evidence of effectiveness is sufficient for drug approval. Clin. Pharmacol. Ther. 73, 481-490 (2003).
    • (2003) Clin. Pharmacol. Ther , vol.73 , pp. 481-490
    • Peck, C.C.1    Rubin, D.B.2    Sheiner, L.B.3
  • 7
    • 34250679464 scopus 로고    scopus 로고
    • Government Accounting Office. New Drug Development: Science, Business, Regulatory, and Intellectual Property Issues Cited as Hampering Drug Development Efforts. Government Accounting Office Report GAO_07_49 (2006).
    • Government Accounting Office. New Drug Development: Science, Business, Regulatory, and Intellectual Property Issues Cited as Hampering Drug Development Efforts. Government Accounting Office Report GAO_07_49 (2006).
  • 8
    • 28244484349 scopus 로고    scopus 로고
    • Stanski, D.R., Rowland, M. & Sheiner, L.B. Getting the dose right: Report from the Tenth European Federation of Pharmaceutical Sciences (EUFEPS) Conference on Optimizing Drug Development, 2005. J. Pharmacokinet. Pharmacodyn. 32, 199-211 (2005).
    • Stanski, D.R., Rowland, M. & Sheiner, L.B. Getting the dose right: Report from the Tenth European Federation of Pharmaceutical Sciences (EUFEPS) Conference on Optimizing Drug Development, 2005. J. Pharmacokinet. Pharmacodyn. 32, 199-211 (2005).
  • 9
    • 34250681907 scopus 로고    scopus 로고
    • European Centre of Pharmaceutical Medicine
    • European Centre of Pharmaceutical Medicine. The ECPM Course 〈http://www.ecpm.ch/ecpm/english/ecpmcourse.html〉.
    • The ECPM Course
  • 11
    • 33646649531 scopus 로고    scopus 로고
    • Bhattaram, V.A. et al. Impact of pharmacometrics on drug approval and labeling decisions: a survey of 42 new drug applications. AAPS J. [online] 7, E503-E512 (2005) (doi:10.1208/aapsj070351) 〈http://www.aapsj.org/view.asp?art=aapsj070351〉.
    • Bhattaram, V.A. et al. Impact of pharmacometrics on drug approval and labeling decisions: a survey of 42 new drug applications. AAPS J. [online] 7, E503-E512 (2005) (doi:10.1208/aapsj070351) 〈http://www.aapsj.org/view.asp?art=aapsj070351〉.
  • 12
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    • Impact of pharmacometric reviews on new drug approval and labeling decisions: A survey of 31 new drug applications submitted between 2005 and 2006
    • Bhattaram, V.A. et al. Impact of pharmacometric reviews on new drug approval and labeling decisions: a survey of 31 new drug applications submitted between 2005 and 2006. Clin. Pharmacol. Ther. 81, 213-221 (2007).
    • (2007) Clin. Pharmacol. Ther , vol.81 , pp. 213-221
    • Bhattaram, V.A.1
  • 20
    • 9144246190 scopus 로고    scopus 로고
    • Drug development and use in the elderly: Search for the right dose and dosing regimen
    • Shah, R.R. Drug development and use in the elderly: search for the right dose and dosing regimen. Br. J. Clin. Pharmacol. 58, 452-469 (2004).
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    • Shah, R.R.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.