Cargando…

Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspective

Detalles Bibliográficos
Autores principales: Manolis, Efthymios, García‐Arieta, Alfredo, Lindahl, Anders, Kotzagiorgis, Evangelos, Limberg, Jobst, Holte, Øyvind, Paixao, Paulo, Versantvoort, Carolien, Tshinanu, Flora Musuamba, Blake, Kevin, Van Den Heuvel, Michiel
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10196408/
https://www.ncbi.nlm.nih.gov/pubmed/36628987
http://dx.doi.org/10.1002/psp4.12906
_version_ 1785044347136245760
author Manolis, Efthymios
García‐Arieta, Alfredo
Lindahl, Anders
Kotzagiorgis, Evangelos
Limberg, Jobst
Holte, Øyvind
Paixao, Paulo
Versantvoort, Carolien
Tshinanu, Flora Musuamba
Blake, Kevin
Van Den Heuvel, Michiel
author_facet Manolis, Efthymios
García‐Arieta, Alfredo
Lindahl, Anders
Kotzagiorgis, Evangelos
Limberg, Jobst
Holte, Øyvind
Paixao, Paulo
Versantvoort, Carolien
Tshinanu, Flora Musuamba
Blake, Kevin
Van Den Heuvel, Michiel
author_sort Manolis, Efthymios
collection PubMed
description
format Online
Article
Text
id pubmed-10196408
institution National Center for Biotechnology Information
language English
publishDate 2023
publisher John Wiley and Sons Inc.
record_format MEDLINE/PubMed
spelling pubmed-101964082023-05-20 Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspective Manolis, Efthymios García‐Arieta, Alfredo Lindahl, Anders Kotzagiorgis, Evangelos Limberg, Jobst Holte, Øyvind Paixao, Paulo Versantvoort, Carolien Tshinanu, Flora Musuamba Blake, Kevin Van Den Heuvel, Michiel CPT Pharmacometrics Syst Pharmacol Perspectives John Wiley and Sons Inc. 2023-01-11 /pmc/articles/PMC10196408/ /pubmed/36628987 http://dx.doi.org/10.1002/psp4.12906 Text en © 2023 The Authors. CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Perspectives
Manolis, Efthymios
García‐Arieta, Alfredo
Lindahl, Anders
Kotzagiorgis, Evangelos
Limberg, Jobst
Holte, Øyvind
Paixao, Paulo
Versantvoort, Carolien
Tshinanu, Flora Musuamba
Blake, Kevin
Van Den Heuvel, Michiel
Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspective
title Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspective
title_full Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspective
title_fullStr Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspective
title_full_unstemmed Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspective
title_short Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspective
title_sort using mechanistic models to support development of complex generic drug products: european medicines agency perspective
topic Perspectives
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10196408/
https://www.ncbi.nlm.nih.gov/pubmed/36628987
http://dx.doi.org/10.1002/psp4.12906
work_keys_str_mv AT manolisefthymios usingmechanisticmodelstosupportdevelopmentofcomplexgenericdrugproductseuropeanmedicinesagencyperspective
AT garciaarietaalfredo usingmechanisticmodelstosupportdevelopmentofcomplexgenericdrugproductseuropeanmedicinesagencyperspective
AT lindahlanders usingmechanisticmodelstosupportdevelopmentofcomplexgenericdrugproductseuropeanmedicinesagencyperspective
AT kotzagiorgisevangelos usingmechanisticmodelstosupportdevelopmentofcomplexgenericdrugproductseuropeanmedicinesagencyperspective
AT limbergjobst usingmechanisticmodelstosupportdevelopmentofcomplexgenericdrugproductseuropeanmedicinesagencyperspective
AT holteøyvind usingmechanisticmodelstosupportdevelopmentofcomplexgenericdrugproductseuropeanmedicinesagencyperspective
AT paixaopaulo usingmechanisticmodelstosupportdevelopmentofcomplexgenericdrugproductseuropeanmedicinesagencyperspective
AT versantvoortcarolien usingmechanisticmodelstosupportdevelopmentofcomplexgenericdrugproductseuropeanmedicinesagencyperspective
AT tshinanufloramusuamba usingmechanisticmodelstosupportdevelopmentofcomplexgenericdrugproductseuropeanmedicinesagencyperspective
AT blakekevin usingmechanisticmodelstosupportdevelopmentofcomplexgenericdrugproductseuropeanmedicinesagencyperspective
AT vandenheuvelmichiel usingmechanisticmodelstosupportdevelopmentofcomplexgenericdrugproductseuropeanmedicinesagencyperspective