메뉴 건너뛰기




Volumn 68, Issue 1, 2007, Pages 14-22

Accelerating drug development: Methodology to support first-in-man pharmacokinetic studies by the use of drug candidate microdosing

Author keywords

Drug development; LC MS; Microdosing; Pharmacokinetics

Indexed keywords

CARBOXYLIC ACID DERIVATIVE;

EID: 34249939529     PISSN: 02724391     EISSN: 10982299     Source Type: Journal    
DOI: 10.1002/ddr.20160     Document Type: Article
Times cited : (12)

References (11)
  • 1
    • 34249939077 scopus 로고    scopus 로고
    • Increased sensitivity for the quantitation of resolved epimers of budesonide extracted from rat plasma utilizing an API 5000 LC-MS/MS system
    • San Antonio, TX. June 5-9
    • Aiello M, Plomley J, Deagon N, Caraiman D. 2005. Increased sensitivity for the quantitation of resolved epimers of budesonide extracted from rat plasma utilizing an API 5000 LC-MS/MS system. Proceedings of the 53rd ASMS Conference on Mass Spectrometry and Allied Topics, San Antonio, TX. June 5-9, 2005.
    • (2005) Proceedings of the 53rd ASMS Conference on Mass Spectrometry and Allied Topics
    • Aiello, M.1    Plomley, J.2    Deagon, N.3    Caraiman, D.4
  • 3
    • 34249930354 scopus 로고    scopus 로고
    • European Medicines Agency (EMEA), Committee for Medicinal Products for Human Use (CHMP). 2004. Position paper on non-clinical safety studies to support clinical trials with a single microdose. CPMP, SWP, 2599, 02, Rev 1, London. 23 June 2004.
    • European Medicines Agency (EMEA), Committee for Medicinal Products for Human Use (CHMP). 2004. Position paper on non-clinical safety studies to support clinical trials with a single microdose. CPMP, SWP, 2599, 02, Rev 1, London. 23 June 2004.
  • 4
    • 17044392336 scopus 로고    scopus 로고
    • Less is more: The human microdosing concept
    • Garner R. 2005. Less is more: the human microdosing concept. Drug Discov Today 10:449-451.
    • (2005) Drug Discov Today , vol.10 , pp. 449-451
    • Garner, R.1
  • 5
    • 0037365932 scopus 로고    scopus 로고
    • Big physics, small doses: The use of AMS and PET in human microdosing of development drugs
    • Lappin G, Garner R. 2003. Big physics, small doses: The use of AMS and PET in human microdosing of development drugs. Nature Rev Drug Discov 2:233-240.
    • (2003) Nature Rev Drug Discov , vol.2 , pp. 233-240
    • Lappin, G.1    Garner, R.2
  • 7
    • 34249940774 scopus 로고    scopus 로고
    • Increased sensitivity utilizing an API 5000 coupled to reduced sample volumes for the analysis of mitoxantrone extracted from neonatal plasma
    • San Antonio, TX. June 5-9
    • Plomley J, Deagon N, Xhong F, Caraiman D. 2005. Increased sensitivity utilizing an API 5000 coupled to reduced sample volumes for the analysis of mitoxantrone extracted from neonatal plasma. Proceedings of the 53rd ASMS Conference on Mass Spectrometry and Allied Topics, San Antonio, TX. June 5-9, 2005.
    • (2005) Proceedings of the 53rd ASMS Conference on Mass Spectrometry and Allied Topics
    • Plomley, J.1    Deagon, N.2    Xhong, F.3    Caraiman, D.4
  • 8
    • 6944241355 scopus 로고    scopus 로고
    • Evaluation of microdosing strategies for studies in preclinical drug development: Demonstration of linear pharmacokinetics in dogs of a nucleoside analog over a 50-fold dose range
    • Sandhu P, Vogel J, Rose M, Ubick E, Brunner J, Wallace M, Adelsberger J, Baker M, Henderson P, Pearson P, Baillie T. 2004. Evaluation of microdosing strategies for studies in preclinical drug development: Demonstration of linear pharmacokinetics in dogs of a nucleoside analog over a 50-fold dose range. Drug Metab Dispos 32:1254-1259.
    • (2004) Drug Metab Dispos , vol.32 , pp. 1254-1259
    • Sandhu, P.1    Vogel, J.2    Rose, M.3    Ubick, E.4    Brunner, J.5    Wallace, M.6    Adelsberger, J.7    Baker, M.8    Henderson, P.9    Pearson, P.10    Baillie, T.11
  • 9
    • 34249933131 scopus 로고    scopus 로고
    • U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). 2005. Guidance for industry, investigators, and reviewers: Exploratory IND studies draft guidance. 6384dft.doc. 07 April 2005.
    • U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). 2005. Guidance for industry, investigators, and reviewers: Exploratory IND studies draft guidance. 6384dft.doc. 07 April 2005.
  • 10
    • 33645993507 scopus 로고    scopus 로고
    • Supplement 19: Use of human microdosing studies to improve the pharmacokinetic/bioavailability (PK/BA) quality of new drug candidates: A practical guide
    • Luscombe D, Stonier P, editors
    • Wilding I. 2005. Supplement 19: Use of human microdosing studies to improve the pharmacokinetic/bioavailability (PK/BA) quality of new drug candidates: A practical guide. In: Luscombe D, Stonier P, editors. Clinical research manual, Haslemere, England: Euromed Communications. p S19.1-S19.10.
    • (2005) Clinical research manual, Haslemere, England: Euromed Communications
    • Wilding, I.1
  • 11
    • 21544448884 scopus 로고    scopus 로고
    • Improved early clinical development through human microdosing studies
    • Wilding I, Bell J. 2005. Improved early clinical development through human microdosing studies. Drug Discov Today 10: 890-894.
    • (2005) Drug Discov Today , vol.10 , pp. 890-894
    • Wilding, I.1    Bell, J.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.