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

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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)

Musuamba, F. T. (författare): EMA Modelling & Simulat Working Grp, London, England.;Fed Agcy Med & Hlth Prod, Brussels, Belgium.;Univ Limoges, INSERM, UMR850, Limoges, France.

Manolis, E. (författare): EMA Modelling & Simulat Working Grp, London, England.;European Med Agcy, London, England.

Holford, N. (författare): Univ Auckland, Dept Pharmacol & Clin Pharmacol, Auckland, New Zealand.

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Cheung, S. Y. A. (författare): AstraZeneca UK Ltd, London, England.

Friberg, Lena E (författare): Uppsala universitet,Institutionen för farmaceutisk biovetenskap

Ogungbenro, K. (författare): Univ Manchester, Manchester, Lancs, England.

Posch, M. (författare): Med Univ Vienna, Ctr Med Stat Informat & Intelligent Syst, Vienna, Austria.

Yates, J. W. T. (författare): AstraZeneca UK Ltd, London, England.

Berry, S. (författare): Berry Consultants, Austin, TX USA.

Thomas, N. (författare): Pfizer, London, England.

Corriol-Rohou, S. (författare): AstraZeneca UK Ltd, London, England.

Bornkamp, B. (författare): Novartis, London, England.

Bretz, F. (författare): Med Univ Vienna, Ctr Med Stat Informat & Intelligent Syst, Vienna, Austria.;Novartis, London, England.

Hooker, Andrew, 1973- (författare): Uppsala universitet,Institutionen för farmaceutisk biovetenskap

Van der Graaf, P. H. (författare): Leiden Acad Ctr Drug Res, Leiden, Netherlands.;Certara QSP, Canterbury, Kent, England.

Standing, J. F. (författare): EMA Modelling & Simulat Working Grp, London, England.;UCL, London, England.

Hay, J. (författare): EMA Modelling & Simulat Working Grp, London, England.;Med & Healthcare Prod Regulatory Agcy, London, England.

Cole, S. (författare): EMA Modelling & Simulat Working Grp, London, England.;Med & Healthcare Prod Regulatory Agcy, London, England.

Gigante, V. (författare): EMA Modelling & Simulat Working Grp, London, England.;Agenzia Italiana Farmaco, Rome, Italy.

Karlsson, K. (författare): EMA Modelling & Simulat Working Grp, London, England.;Med Prod Agcy, Uppsala, Sweden.

Dumortier, T. (författare): Novartis, London, England.

Benda, N. (författare): EMA Modelling & Simulat Working Grp, London, England.;Bundesinst Arzneimittel & Med Prod, Bonn, Germany.

Serone, F. (författare): EMA Modelling & Simulat Working Grp, London, England.;Agenzia Italiana Farmaco, Rome, Italy.

Das, S. (författare): AstraZeneca UK Ltd, London, England.

Brochot, A. (författare): ABLYNX, Ghent, Belgium.

Ehmann, F. (författare): European Med Agcy, London, England.

Hemmings, R. (författare): Med & Healthcare Prod Regulatory Agcy, London, England.

Rusten, I. Skottheim (författare): EMA Modelling & Simulat Working Grp, London, England.;Norvegian Med Agcy, Oslo, Norway.

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EMA Modelling & Simulat Working Grp, London, England;Fed Agcy Med & Hlth Prod, Brussels, Belgium.;Univ Limoges, INSERM, UMR850, Limoges, France. EMA Modelling & Simulat Working Grp, London, England.;European Med Agcy, London, England. (creator_code:org_t)

2017-07-19
2017
Engelska.
Ingår i: CPT. - : Wiley. - 2163-8306. ; 6:7, s. 418-429

Relaterad länk:: https://doi.org/10.1...; visa fler...; https://urn.kb.se/re...; https://doi.org/10.1...; visa färre...

Tidskriftsartikel (refereegranskat)

Abstract Ämnesord

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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 regulatory institutions. In an effort to shift the current paradigm in dose and regimen selection and highlight the availability and usefulness of well-established and regulatory-acceptable methods, the European Medicines Agency (EMA) in collaboration with the European Federation of Pharmaceutical Industries Association (EFPIA) hosted a multistakeholder workshop on dose finding (London 4-5 December 2014). Some methodologies that could constitute a toolkit for drug developers and regulators were presented. These methods are described in the present report: they include five advanced methods for data analysis (empirical regression models, pharmacometrics models, quantitative systems pharmacology models, MCP-Mod, and model averaging) and three methods for study design optimization (Fisher information matrix (FIM)-based methods, clinical trial simulations, and adaptive studies). Pairwise comparisons were also discussed during the workshop; however, mostly for historical reasons. This paper discusses the added value and limitations of these methods as well as challenges for their implementation. Some applications in different therapeutic areas are also summarized, in line with the discussions at the workshop. There was agreement at the workshop on the fact that selection of dose for phase III is an estimation problem and should not be addressed via hypothesis testing. Dose selection for phase III trials should be informed by well-designed dosefinding studies; however, the specific choice of method(s) will depend on several aspects and it is not possible to recommend a generalized decision tree. There are many valuable methods available, the methods are not mutually exclusive, and they should be used in conjunction to ensure a scientifically rigorous understanding of the dosing rationale.

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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)

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