Advanced methods for dose and regimen finding during drug development:Summary of the EMA /EFPIA workshop on dose finding (London 4-5 December 2014)

Autor: Musuamba, F. T., Manolis, E., Holford, N., Cheung, S. Y. A., Friberg, Lena E, Ogungbenro, K., Posch, M., Yates, J. W. T., Berry, S., Thomas, N., Corriol-Rohou, S., Bornkamp, B., Bretz, F., Hooker, Andrew, Van der Graaf, P. H., Standing, J. F., Hay, J., Cole, S., Gigante, V., Karlsson, K., Dumortier, T., Benda, N., Serone, F., Das, S., Brochot, A., Ehmann, F., Hemmings, R., Rusten, I. Skottheim

Publikováno v: Musuamba, F T, Manolis, E, Holford, N, Cheung, S Y A, Friberg, L, Ogungbenro, K, Posch, M, Yates, J, Berry, S, Thomas, N, Corriol-Rohou, S, Bornkamp, B, Bretz, F, Hooker, A C, Van Der Graaf, P H, Standing, J, Pittaway-Hay, J, Cole, S, Gigante, V, Karlsson, K, Dumortier, T, Benda, N, Serone, F, Das, S, Brochot, A, Falk, E, Hemmings, R & Skottheim Rusten, I 2017, ' Advanced methods for dose and regimen finding during drug development : Summary of the EMA /EFPIA workshop on dose finding (London 4-5 December 2014) ', Clinical Pharmacology & Therapeutics, vol. 6, no. 7 . https://doi.org/10.1002/psp4.12196
CPT: Pharmacometrics & Systems Pharmacology

Inadequate dose selection for confirmatory trials is currently still one of the most challenging issues in drug development, as illustrated by high rates of late-stage attritions in clinical development and postmarketing commitments required by regul

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https://doi.org/10.1002/psp4.12196

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Advanced Methods for Dose and Regimen Finding During Drug Development: Summary of the EMA/EFPIA Workshop on Dose Finding (London 4-5 December 2014).

Autor: Musuamba FT; EMA Modelling and Simulation Working Group, London, UK.; Federal Agency for Medicines and Health Products, Brussels, Belgium.; UMR850 INSERM, Université de Limoges, Limoges, France., Manolis E; EMA Modelling and Simulation Working Group, London, UK.; European Medicines Agency, London, UK., Holford N; Department of Pharmacology & Clinical Pharmacology, University of Auckland, Auckland, New Zealand., Cheung S; AstraZeneca UK Limited, London, UK., Friberg LE; Uppsala University, Uppsala, Sweden., Ogungbenro K; Manchester University, Manchester, UK., Posch M; Center for Medical Statistics, Informatics and Intelligent Systems, Medical University of Vienna, Vienna, Austria., Yates J; AstraZeneca UK Limited, London, UK., Berry S; Berry consultants, Austin, Texas, USA., Thomas N; Pfizer, London, UK., Corriol-Rohou S; AstraZeneca UK Limited, London, UK., Bornkamp B; Novartis, London, UK., Bretz F; Center for Medical Statistics, Informatics and Intelligent Systems, Medical University of Vienna, Vienna, Austria.; Novartis, London, UK., Hooker AC; Uppsala University, Uppsala, Sweden., Van der Graaf PH; Leiden Academic Centre for Drug Research, Leiden, The Netherlands.; Certara QSP, Canterbury, UK., Standing JF; EMA Modelling and Simulation Working Group, London, UK.; University College London, London, UK., Hay J; EMA Modelling and Simulation Working Group, London, UK.; Medicines and Healthcare Products Regulatory Agency, London, UK., Cole S; EMA Modelling and Simulation Working Group, London, UK.; Medicines and Healthcare Products Regulatory Agency, London, UK., Gigante V; EMA Modelling and Simulation Working Group, London, UK.; Agenzia Italiana del Farmaco, Roma, Italy., Karlsson K; EMA Modelling and Simulation Working Group, London, UK.; Medical Products Agency, Uppsala, Sweden., Dumortier T; Novartis, London, UK., Benda N; EMA Modelling and Simulation Working Group, London, UK.; Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn, Germany., Serone F; EMA Modelling and Simulation Working Group, London, UK.; Agenzia Italiana del Farmaco, Roma, Italy., Das S; AstraZeneca UK Limited, London, UK., Brochot A; ABLYNX, Gent, Belgium., Ehmann F; European Medicines Agency, London, UK., Hemmings R; Medicines and Healthcare Products Regulatory Agency, London, UK., Rusten IS; EMA Modelling and Simulation Working Group, London, UK.; Norvegian Medicines Agency, Oslo, Norway.

Publikováno v: CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2017 Jul; Vol. 6 (7), pp. 418-429. Date of Electronic Publication: 2017 Jul 19.