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Volumn 2, Issue 2, 2013, Pages

Modeling and simulation at the interface of nonclinical and early clinical drug development

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL ACTIVITY; DOSE CALCULATION; DRUG DEVELOPMENT; DRUG DOSE ESCALATION; DRUG SAFETY; HUMAN; MEDICAL INFORMATION SYSTEM; MODEL; PREDICTIVE VALUE; PRIORITY JOURNAL; REVIEW; SIMULATION;

EID: 84881037647     PISSN: None     EISSN: 21638306     Source Type: Journal    
DOI: 10.1038/psp.2013.3     Document Type: Review
Times cited : (14)

References (10)
  • 1
    • 63149182785 scopus 로고    scopus 로고
    • Early integration of pharmacokinetic and dynamic reasoning is essential for optimal development of lead compounds: Strategic considerations
    • Gabrielsson, J., Dolgos, H., Gillberg, P.G., Bredberg, U., Benthem, B. & Duker, G. Early integration of pharmacokinetic and dynamic reasoning is essential for optimal development of lead compounds: strategic considerations. Drug Discov. Today 14, 358-372 (2009).
    • (2009) Drug Discov. Today , vol.14 , pp. 358-372
    • Gabrielsson, J.1    Dolgos, H.2    Gillberg, P.G.3    Bredberg, U.4    Benthem, B.5    Duker, G.6
  • 2
    • 84860690620 scopus 로고    scopus 로고
    • Can the flow of medicines be improved? Fundamental pharmacokinetic and pharmacological principles toward improving Phase II survival
    • Morgan, P. et al. Can the flow of medicines be improved? Fundamental pharmacokinetic and pharmacological principles toward improving Phase II survival. Drug Discov. Today 17, 419-424 (2012).
    • (2012) Drug Discov. Today , vol.17 , pp. 419-424
    • Morgan, P.1
  • 3
    • 33847028671 scopus 로고    scopus 로고
    • Mechanism-based pharmacokinetic-pharmacodynamic modeling: Biophase distribution, receptor theory, and dynamical systems analysis
    • Danhof, M., de Jongh, J., De Lange, E.C., Della Pasqua, O., Ploeger, B.A. & Voskuyl, R.A. Mechanism-based pharmacokinetic-pharmacodynamic modeling: biophase distribution, receptor theory, and dynamical systems analysis. Annu. Rev. Pharmacol. Toxicol. 47, 357-400 (2007).
    • (2007) Annu. Rev. Pharmacol. Toxicol. , vol.47 , pp. 357-400
    • Danhof, M.1    De Jongh, J.2    De Lange, E.C.3    Della Pasqua, O.4    Ploeger, B.A.5    Voskuyl, R.A.6
  • 5
    • 84881200963 scopus 로고    scopus 로고
    • CPT: Pharmacometrics and systems pharmacology cpt pharmacometrics syst
    • Van der Graaf, P.H. CPT: Pharmacometrics and Systems Pharmacology. CPT Pharmacometrics Syst. Pharmacol. 1, 8 (2012).
    • (2012) Pharmacol. , vol.1 , pp. 8
    • Van Der Graaf, P.H.1
  • 7
    • 35648945837 scopus 로고    scopus 로고
    • On the anticipation of the human dose in first-in-man trials from preclinical and prior clinical information in early drug development
    • DOI 10.1080/00498250701648008, PII 783595319, Modelling and Simulation Approaches to in vitro-in vivo, Extrapolation of ADME Properties in Drug Development, Editor: Gordon Gibson, Guest Editor: Amin Rostami-Hodjegan
    • Lowe, P.J., Hijazi, Y., Luttringer, O., Yin, H., Sarangapani, R. & Howard, D. On the anticipation of the human dose in first-in-man trials from preclinical and prior clinical information in early drug development. Xenobiotica. 37, 1331-1354 (2007). (Pubitemid 350035529)
    • (2007) Xenobiotica , vol.37 , Issue.10-11 , pp. 1331-1354
    • Lowe, P.J.1    Hijazi, Y.2    Luttringer, O.3    Yin, H.4    Sarangapani, R.5    Howard, D.6
  • 8
    • 43649102392 scopus 로고    scopus 로고
    • Pharmacokinetic and pharmacodynamic data to be derived from early-phase drug development: Designing informative human pharmacology studies
    • DOI 10.2165/00003088-200847060-00002
    • Cohen, A. Pharmacokinetic and pharmacodynamic data to be derived from early-phase drug development: designing informative human pharmacology studies. Clin. Pharmacokinet. 47, 373-381 (2008). (Pubitemid 351685387)
    • (2008) Clinical Pharmacokinetics , vol.47 , Issue.6 , pp. 373-381
    • Cohen, A.1
  • 9
    • 79957618123 scopus 로고    scopus 로고
    • New pathway for qualification of novel methodologies in the European Medicines Agency
    • Manolis, E., Vamvakas, S. & Isaac, M. New pathway for qualification of novel methodologies in the European Medicines Agency. Proteomics. Clin. Appl. 5, 248-255 (2011).
    • (2011) Proteomics. Clin. Appl. , vol.5 , pp. 248-255
    • Manolis, E.1    Vamvakas, S.2    Isaac, M.3
  • 10
    • 84878254933 scopus 로고    scopus 로고
    • How to use Modeling and Simulation in Clinical Development: Output from the EFPIA/EMA Modeling and Simulation Workshop
    • Manolis, E. et al. How to use Modeling and Simulation in Clinical Development: Output from the EFPIA/EMA Modeling and Simulation Workshop. CPT Pharmacometrics Syst. Pharmacol. 2, e31 (2013).
    • (2013) CPT Pharmacometrics Syst. Pharmacol. , vol.2
    • Manolis, E.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.