Model-Informed Drug Development: Steps Toward Harmonized Guidance

Scott Marshall; Malidi Ahamadi; Jenny Chien; Daisuke Iwata; Pavel Farkas; Augusto Filipe; Nicolas Frey; Erin Greene; Norisuke Kawai; Jian Li; Jörg Lippert; Flora Musuamba Tshinanu; Efthymios Manolis; Mark C. Peterson; Sarem Sarem; Mohamad Shebley; Million Tegenge; Chia Hsun Tsai; Chien Lung Tu; Yasuto Otsubo; Jiawei Wei; Lucia Zhang; Hao Zhu; Kristin E. Karlsson

doi:10.1002/cpt.3006

Model-Informed Drug Development: Steps Toward Harmonized Guidance

Scott Marshall, Malidi Ahamadi, Jenny Chien, Daisuke Iwata, Pavel Farkas, Augusto Filipe, Nicolas Frey, Erin Greene, Norisuke Kawai, Jian Li, Jörg Lippert, Flora Musuamba Tshinanu, Efthymios Manolis, Mark C. Peterson, Sarem Sarem, Mohamad Shebley, Million Tegenge, Chia Hsun Tsai, Chien Lung Tu, Yasuto OtsuboJiawei Wei, Lucia Zhang, Hao Zhu, Kristin E. Karlsson

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Résumé

Global alignment of expectations is required to achieve consistency in the planning, conduct, reporting, and regulatory review of modelinformed drug development (MIDD) applications. An International Council for Harmonization (ICH) MIDD general principles guideline has been positioned to provide a common standard of practice including a framework for risk-based assessment of MIDD-derived evidence within the context of global regulatory decision-making. This perspective provides the background, our viewpoints, and the next steps in the development of this guideline.

langue originale	Anglais
Pages (de - à)	954-959
Nombre de pages	6
journal	Clinical Pharmacology and Therapeutics
Volume	114
Numéro de publication	5
Les DOIs	https://doi.org/10.1002/cpt.3006
Etat de la publication	Publié - nov. 2023

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10.1002/cpt.3006

Clin Pharma and Therapeutics - 2023 - Marshall - Model‐Informed Drug Development Steps Toward Harmonized GuidanceVersion finale publiée, 366 KBLicense: CC BY

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Marshall, S., Ahamadi, M., Chien, J., Iwata, D., Farkas, P., Filipe, A., Frey, N., Greene, E., Kawai, N., Li, J., Lippert, J., Musuamba Tshinanu, F., Manolis, E., Peterson, M. C., Sarem, S., Shebley, M., Tegenge, M., Tsai, C. H., Tu, C. L., ... Karlsson, K. E. (2023). Model-Informed Drug Development: Steps Toward Harmonized Guidance. Clinical Pharmacology and Therapeutics, 114(5), 954-959. https://doi.org/10.1002/cpt.3006

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title = "Model-Informed Drug Development: Steps Toward Harmonized Guidance",

abstract = "Global alignment of expectations is required to achieve consistency in the planning, conduct, reporting, and regulatory review of modelinformed drug development (MIDD) applications. An International Council for Harmonization (ICH) MIDD general principles guideline has been positioned to provide a common standard of practice including a framework for risk-based assessment of MIDD-derived evidence within the context of global regulatory decision-making. This perspective provides the background, our viewpoints, and the next steps in the development of this guideline.",

author = "Scott Marshall and Malidi Ahamadi and Jenny Chien and Daisuke Iwata and Pavel Farkas and Augusto Filipe and Nicolas Frey and Erin Greene and Norisuke Kawai and Jian Li and J{\"o}rg Lippert and {Musuamba Tshinanu}, Flora and Efthymios Manolis and Peterson, {Mark C.} and Sarem Sarem and Mohamad Shebley and Million Tegenge and Tsai, {Chia Hsun} and Tu, {Chien Lung} and Yasuto Otsubo and Jiawei Wei and Lucia Zhang and Hao Zhu and Karlsson, {Kristin E.}",

year = "2023",

month = nov,

doi = "10.1002/cpt.3006",

language = "English",

volume = "114",

pages = "954--959",

journal = "Clinical Pharmacology and Therapeutics",

issn = "0009-9236",

publisher = "Wiley-Blackwell",

number = "5",

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Marshall, S, Ahamadi, M, Chien, J, Iwata, D, Farkas, P, Filipe, A, Frey, N, Greene, E, Kawai, N, Li, J, Lippert, J, Musuamba Tshinanu, F, Manolis, E, Peterson, MC, Sarem, S, Shebley, M, Tegenge, M, Tsai, CH, Tu, CL, Otsubo, Y, Wei, J, Zhang, L, Zhu, H & Karlsson, KE 2023, 'Model-Informed Drug Development: Steps Toward Harmonized Guidance', Clinical Pharmacology and Therapeutics, VOL. 114, Numéro 5, p. 954-959. https://doi.org/10.1002/cpt.3006

TY - JOUR

T1 - Model-Informed Drug Development

T2 - Steps Toward Harmonized Guidance

AU - Marshall, Scott

AU - Ahamadi, Malidi

AU - Chien, Jenny

AU - Iwata, Daisuke

AU - Farkas, Pavel

AU - Filipe, Augusto

AU - Frey, Nicolas

AU - Greene, Erin

AU - Kawai, Norisuke

AU - Li, Jian

AU - Lippert, Jörg

AU - Musuamba Tshinanu, Flora

AU - Manolis, Efthymios

AU - Peterson, Mark C.

AU - Sarem, Sarem

AU - Shebley, Mohamad

AU - Tegenge, Million

AU - Tsai, Chia Hsun

AU - Tu, Chien Lung

AU - Otsubo, Yasuto

AU - Wei, Jiawei

AU - Zhang, Lucia

AU - Zhu, Hao

AU - Karlsson, Kristin E.

PY - 2023/11

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N2 - Global alignment of expectations is required to achieve consistency in the planning, conduct, reporting, and regulatory review of modelinformed drug development (MIDD) applications. An International Council for Harmonization (ICH) MIDD general principles guideline has been positioned to provide a common standard of practice including a framework for risk-based assessment of MIDD-derived evidence within the context of global regulatory decision-making. This perspective provides the background, our viewpoints, and the next steps in the development of this guideline.

AB - Global alignment of expectations is required to achieve consistency in the planning, conduct, reporting, and regulatory review of modelinformed drug development (MIDD) applications. An International Council for Harmonization (ICH) MIDD general principles guideline has been positioned to provide a common standard of practice including a framework for risk-based assessment of MIDD-derived evidence within the context of global regulatory decision-making. This perspective provides the background, our viewpoints, and the next steps in the development of this guideline.

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JO - Clinical Pharmacology and Therapeutics

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Model-Informed Drug Development: Steps Toward Harmonized Guidance

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