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Volumn 2, Issue 2, 2013, Pages

Modeling and simulation as a tool to bridge efficacy and safety data in special populations

Author keywords

[No Author keywords available]

Indexed keywords

CONCEPTUAL FRAMEWORK; DATA BASE; DECISION MAKING; DOSE CALCULATION; DRUG SAFETY; DRUG USE; EVIDENCE BASED PRACTICE; MEDICINE; PRIORITY JOURNAL; REGISTRATION; REVIEW; RISK ASSESSMENT;

EID: 84881137095     PISSN: None     EISSN: 21638306     Source Type: Journal    
DOI: 10.1038/psp.2013.6     Document Type: Review
Times cited : (32)

References (10)
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    • PSI health technology special interest group, evidence synthesis subteam statistical approaches for conducting network meta-analysis in drug development
    • Jones, B. et al.; PSI Health Technology Special Interest Group, Evidence Synthesis subteam. Statistical approaches for conducting network meta-analysis in drug development. Pharm. Stat. 10, 523-531 (2011).
    • (2011) Pharm. Stat. , vol.10 , pp. 523-531
    • Jones, B.1
  • 3
    • 70449105165 scopus 로고    scopus 로고
    • Proposals for model-based paediatric medicinal development within the current european union regulatory framework
    • Manolis, E. & Pons, G. Proposals for model-based paediatric medicinal development within the current European Union regulatory framework. Br. J. Clin. Pharmacol. 68, 493-501 (2009).
    • (2009) Br. J. Clin. Pharmacol. , vol.68 , pp. 493-501
    • Manolis, E.1    Pons, G.2
  • 5
    • 77949272179 scopus 로고    scopus 로고
    • Ethnic differences in the population pharmacokinetics and pharmacodynamics of warfarin
    • Yuen, E., Gueorguieva, I., Wise, S., Soon, D. & Aarons, L. Ethnic differences in the population pharmacokinetics and pharmacodynamics of warfarin. J. Pharmacokinet. Pharmacodyn. 37, 3-24 (2010).
    • (2010) J. Pharmacokinet. Pharmacodyn. , vol.37 , pp. 3-24
    • Yuen, E.1    Gueorguieva, I.2    Wise, S.3    Soon, D.4    Aarons, L.5
  • 6
    • 84881164721 scopus 로고    scopus 로고
    • European Medicines Agency. Human Medicines Development and Evaluation. Concept paper on extrapolation of efficacy and safety in medicine development. EMA/129698/2012 (2012).
    • European Medicines Agency. Human Medicines Development and Evaluation. Concept paper on extrapolation of efficacy and safety in medicine development. EMA/129698/2012 (http://www.ema.europa.eu/docs/en-GB/document-library/ Scientific-guideline/2012/06/WC500129285.pdf) (2012).
  • 7
    • 79955580428 scopus 로고    scopus 로고
    • Modelling and simulation as research tools in paediatric drug development
    • Bellanti, F. & Della Pasqua, O. Modelling and simulation as research tools in paediatric drug development. Eur. J. Clin. Pharmacol. 67 Suppl 1, 75-86 (2011).
    • (2011) Eur. J. Clin. Pharmacol. , vol.67 , Issue.SUPPL. 1 , pp. 75-86
    • Bellanti, F.1    Della Pasqua, O.2
  • 9
    • 33646461154 scopus 로고    scopus 로고
    • Incorporating direct and indirect evidence using Bayesian methods: An applied case study in ovarian cancer
    • DOI 10.1111/j.1524-4733.2006.00090.x
    • Griffin, S., Bojke, L., Main, C. & Palmer, S. Incorporating direct and indirect evidence using bayesian methods: an applied case study in ovarian cancer. Value Health 9, 123-131 (2006). (Pubitemid 44044745)
    • (2006) Value in Health , vol.9 , Issue.2 , pp. 123-131
    • Griffin, S.1    Bojke, L.2    Main, C.3    Palmer, S.4
  • 10
    • 0142246372 scopus 로고    scopus 로고
    • Statistical methodology relevant to the overall drug development program
    • Bauer, P. Statistical methodology relevant to the overall drug development program. Drug Inf. J. 37, 81-89 (2003). (Pubitemid 37305155)
    • (2003) Drug Information Journal , vol.37 , Issue.1 , pp. 81-89
    • Bauer, P.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.