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Volumn 47, Issue 1, 2011, Pages 8-13

Innovative approaches to clinical development and trial design

Author keywords

Clinical trial; Drug approval; Pharmaceutical preparations

Indexed keywords

ARTICLE; BAYES THEOREM; CLINICAL PHARMACOLOGY; CLINICAL TRIAL (TOPIC); HUMAN; METHODOLOGY; SAMPLE SIZE; STATISTICAL MODEL; STATISTICS;

EID: 79953111778     PISSN: 00212571     EISSN: None     Source Type: Journal    
DOI: 10.4415/ANN-11-01-03     Document Type: Article
Times cited : (12)

References (36)
  • 2
    • 4444342056 scopus 로고    scopus 로고
    • Rebuilding big pharma's business model
    • Gilbert J, Henske P, Singh A. Rebuilding big pharma's business model. In Vivo 2003;21:1-4.
    • (2003) Vivo , vol.21 , pp. 1-4
    • Gilbert, J.1    Henske, P.2    Singh, A.3
  • 3
    • 4344645978 scopus 로고    scopus 로고
    • Can the pharmaceutical industry reduce attrition rates?
    • Kola I, Landis J. Can the pharmaceutical industry reduce attrition rates? Nature Rev Drug Discov 2004:3:711-6.
    • (2004) Nature Rev Drug Discov , vol.3 , pp. 711-716
    • Kola, I.1    Landis, J.2
  • 4
    • 79953100604 scopus 로고    scopus 로고
    • Budget US Govt., App., FY 1993-2003
    • Budget US Govt., App., FY 1993-2003.
  • 6
    • 74749088503 scopus 로고    scopus 로고
    • Spending on new drug development
    • Adams CP, Brantner VV. Spending on new drug development. Health Econ 2009;19:130-41.
    • (2009) Health Econ , vol.19 , pp. 130-141
    • Adams, C.P.1    Brantner, V.V.2
  • 7
    • 0037374498 scopus 로고    scopus 로고
    • The price of innovation: New estimates of drug development costs
    • DOI 10.1016/S0167-6296(02)00126-1
    • DiMasi J A, Hansen RW, Grabowski HG. The price of innovation: new estimates of drug development costs. J Health Econ 2003;22:151-85. (Pubitemid 36279392)
    • (2003) Journal of Health Economics , vol.22 , Issue.2 , pp. 151-185
    • DiMasi, J.A.1    Hansen, R.W.2    Grabowski, H.G.3
  • 8
    • 33645675960 scopus 로고    scopus 로고
    • Market watch : Estimating the cost of new drug development: Is it really $802 million?
    • DOI 10.1377/hlthaff.25.2.420
    • Adams C, Brantner VV. Estimating the cost of new drug development: is it really $ 802 million? Health Aff 2006;2:420-8. (Pubitemid 43529550)
    • (2006) Health Affairs , vol.25 , Issue.2 , pp. 420-428
    • Adams, C.P.1    Van Brantner, V.2
  • 10
  • 12
    • 0030890279 scopus 로고    scopus 로고
    • Relevance of the application of pharmacokinetic-pharmacodynamic modelling concepts in drug development. The 'wooden shoe' paradigm
    • Breimer DD, Danhof M. Relevance of the application of pharmacokinetic-pharmacodynamic modeling concepts in drug development. The "Wooden Shoe" paradigm. Clin Pharmacokinet 1997;32:259-67. (Pubitemid 27160610)
    • (1997) Clinical Pharmacokinetics , vol.32 , Issue.4 , pp. 259-267
    • Breimer, D.D.1    Danhof, M.2
  • 13
    • 24044497597 scopus 로고    scopus 로고
    • Mechanism-based pharmacokinetic-pharmacodynamic modeling - A new classification of biomarkers
    • DOI 10.1007/s11095-005-5882-3
    • Danhof M, Alvan G, Dahl SG, Kuhlmann J, Paintaud G. Mechanism-based pharmacokinetic/pharmacodynamic modeling- a new classification of biomarkers. Pharm Res 2005;22:1432-7. (Pubitemid 41215882)
    • (2005) Pharmaceutical Research , vol.22 , Issue.9 , pp. 1432-1437
    • Danhof, M.1    Alvan, G.2    Dahl, S.G.3    Kuhlmann, J.4    Paintaud, G.5
  • 16
    • 33748770078 scopus 로고    scopus 로고
    • Bayesian statistics
    • DOI 10.1177/0272989X06294372
    • Berry DA. Bayesian statistics. Med Decis Making 2006;26: 429-30. (Pubitemid 44410293)
    • (2006) Medical Decision Making , vol.26 , Issue.5 , pp. 429-430
    • Berry, D.A.1
  • 18
  • 19
  • 20
    • 79953114818 scopus 로고    scopus 로고
    • US Food and Drug Administration. Division of Pharmacometrics
    • US Food and Drug Administration. Division of Pharmacometrics. Selected pharmacosmetics review, guidance and presentations. Available from: www.fda.gov/AboutFDA/CentersOffices/ CDER/ucm167032.htm.
    • Selected Pharmacosmetics Review, Guidance and Presentations
  • 21
    • 15244355194 scopus 로고    scopus 로고
    • Modeling and simulation of clinical trials: An industrial perspective
    • Kimko HC, Duffull SB (Ed.). New York, USA: Marcel Dekker
    • Goggin T, et al. Modeling and simulation of clinical trials: an industrial perspective. In:Simulation for designing of clinical trials. Kimko HC, Duffull SB (Ed.). New York, USA: Marcel Dekker; 2002.
    • (2002) Simulation for Designing of Clinical Trials
    • Goggin, T.1
  • 22
    • 0030849120 scopus 로고    scopus 로고
    • An evaluation of the integration of pharmacokinetic and pharmacodynamic principles in clinical drug development. Experience with Hoffmann La Roche
    • Reigner BG, et al. An evaluation of the integration of pharmacokinetic and pharmacodynamic principles in clinical drug development. Experience within Hoffman La Roche. Clin Pharmacokinet 1997;33:142-52. (Pubitemid 27336953)
    • (1997) Clinical Pharmacokinetics , vol.33 , Issue.2 , pp. 142-152
    • Reigner, B.G.1    Williams, P.E.O.2    Patel, I.H.3    Steimer, J.-L.4    Peck, C.5    Van Brummelen, P.6
  • 23
    • 66649102432 scopus 로고    scopus 로고
    • Use of canakinumab in the cryopyrin- associated periodic syndrome
    • Lachmann HJ, et al. Use of canakinumab in the cryopyrin- associated periodic syndrome. N Engl J Med 2009;360:2416-25.
    • (2009) N Engl J Med , vol.360 , pp. 2416-2425
    • Lachmann, H.J.1
  • 24
    • 33644861229 scopus 로고    scopus 로고
    • Bayesian clinical trials
    • Berry DA. Bayesian clinical trials. Nature Rev Drug Discov 2006;5:27-36.
    • (2006) Nature Rev Drug Discov , vol.5 , pp. 27-36
    • Berry, D.A.1
  • 25
    • 24944510799 scopus 로고    scopus 로고
    • Introduction to Bayesian methods III: Use and interpretation of Bayesian tools in design and analysis
    • DOI 10.1191/1740774505cn100oa
    • Berry DA. Introduction to Bayesian methods. III. Use and interpretation of Bayesian tools in design and analysis. Clin Trials 2005;2:295-300. (Pubitemid 41306270)
    • (2005) Clinical Trials , vol.2 , Issue.4 , pp. 295-300
    • Berry, D.A.1
  • 28
    • 33646245937 scopus 로고    scopus 로고
    • Adaptive designs in clinical drug development - An executive summary of the PhRMA Working Group
    • Gallo P, et al. Adaptive designs in clinical drug development - an executive summary of the PhRMA Working Group. J Biopharm Stat 2006;16:275-83.
    • (2006) J Biopharm Stat , vol.16 , pp. 275-283
    • Gallo, P.1
  • 30
    • 36249016380 scopus 로고    scopus 로고
    • Flexible design and efficient implementation of adaptive dose-finding studies
    • DOI 10.1080/10543400701643947, PII 785295858
    • Weir CJ, Spiegelhalter DJ, Grieve AP. Flexible design and efficient implementation of adaptive dose-finding studies. J Biopharm Stat 2007;17:1033-50. (Pubitemid 350135833)
    • (2007) Journal of Biopharmaceutical Statistics , vol.17 , Issue.6 , pp. 1033-1050
    • Weir, C.J.1    Spiegelhalter, D.J.2    Grieve, A.P.3
  • 31
    • 33748521268 scopus 로고    scopus 로고
    • Confirmatory seamless phase II/III clinical trials with hypotheses selection at interim: General concepts
    • DOI 10.1002/bimj.200510232
    • Bretz F, Schmidli H, König F, Racine A, Maurer W. Confirmatory seamless Phase II/III clinical trials with hypotheses selection at interim: general concepts. Biom J 2006;48:623-34. (Pubitemid 44367905)
    • (2006) Biometrical Journal , vol.48 , Issue.4 , pp. 623-634
    • Bretz, F.1    Schmidli, H.2    Konig, F.3    Racine, A.4    Maurer, W.5
  • 32
    • 33748576736 scopus 로고    scopus 로고
    • Adaptive, group sequential and decision theoretic approaches to sample size determination
    • DOI 10.1002/sim.2638
    • Mehta CR, Patel NR. Adaptive, group sequential and decision theoretic approaches to sample size determination. Stat Med 2006;25:3250-69. (Pubitemid 44489392)
    • (2006) Statistics in Medicine , vol.25 , Issue.19 , pp. 3250-3269
    • Mehta, C.R.1    Patel, N.R.2
  • 34
    • 33749352000 scopus 로고    scopus 로고
    • The need for more efficient trial designs
    • DOI 10.1002/sim.2629
    • Golub HL. The need for more efficient clinical trials. Stat Med 2006;25:3231-5. (Pubitemid 44489389)
    • (2006) Statistics in Medicine , vol.25 , Issue.19 , pp. 3231-3235
    • Golub, H.L.1
  • 35
    • 1842826262 scopus 로고    scopus 로고
    • On the inefficiency of the adaptive design for monitoring clinical trials
    • DOI 10.1093/biomet/90.2.367
    • Tsiatis AA, Mehta C. On the inefficiency of the adaptive design for monitoring clinical trials. Biometrika 2003;90:367-78. (Pubitemid 39047164)
    • (2003) Biometrika , vol.90 , Issue.2 , pp. 367-378
    • Tsiatis, A.A.1    Mehta, C.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.