Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspective
| Main Authors: | , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2023-05-01
|
| Series: | CPT: Pharmacometrics & Systems Pharmacology |
| Online Access: | https://doi.org/10.1002/psp4.12906 |
| _version_ | 1797823648835305472 |
|---|---|
| author | Efthymios Manolis Alfredo García‐Arieta Anders Lindahl Evangelos Kotzagiorgis Jobst Limberg Øyvind Holte Paulo Paixao Carolien Versantvoort Flora Musuamba Tshinanu Kevin Blake Michiel Van Den Heuvel |
| author_facet | Efthymios Manolis Alfredo García‐Arieta Anders Lindahl Evangelos Kotzagiorgis Jobst Limberg Øyvind Holte Paulo Paixao Carolien Versantvoort Flora Musuamba Tshinanu Kevin Blake Michiel Van Den Heuvel |
| author_sort | Efthymios Manolis |
| collection | DOAJ |
| first_indexed | 2024-03-13T10:27:01Z |
| format | Article |
| id | doaj.art-a77d355ba57d45bbaaac7700cf82f8a7 |
| institution | Directory Open Access Journal |
| issn | 2163-8306 |
| language | English |
| last_indexed | 2024-03-13T10:27:01Z |
| publishDate | 2023-05-01 |
| publisher | Wiley |
| record_format | Article |
| series | CPT: Pharmacometrics & Systems Pharmacology |
| spelling | doaj.art-a77d355ba57d45bbaaac7700cf82f8a72023-05-19T06:03:15ZengWileyCPT: Pharmacometrics & Systems Pharmacology2163-83062023-05-0112555655910.1002/psp4.12906Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspectiveEfthymios Manolis0Alfredo García‐Arieta1Anders Lindahl2Evangelos Kotzagiorgis3Jobst Limberg4Øyvind Holte5Paulo Paixao6Carolien Versantvoort7Flora Musuamba Tshinanu8Kevin Blake9Michiel Van Den Heuvel10European Medicines Agency Amsterdam The NetherlandsSpanish Agency of Medicines and Medical Devices Madrid SpainSwedish Medical Products Agency Uppsala SwedenEuropean Medicines Agency Amsterdam The NetherlandsFederal Institute of Drugs and Medical Devises Bonn GermanyNorwegian Medicines Agency Oslo NorwayINFARMED ‐ National Authority of Medicines and Health Products Lisbon PortugalMedicines Evaluation Board Utrecht The NetherlandsFederal Agency for Medicines and Health Products Brussels BelgiumEuropean Medicines Agency Amsterdam The NetherlandsMedicines Evaluation Board Utrecht The Netherlandshttps://doi.org/10.1002/psp4.12906 |
| spellingShingle | Efthymios Manolis Alfredo García‐Arieta Anders Lindahl Evangelos Kotzagiorgis Jobst Limberg Øyvind Holte Paulo Paixao Carolien Versantvoort Flora Musuamba Tshinanu Kevin Blake Michiel Van Den Heuvel Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspective CPT: Pharmacometrics & Systems Pharmacology |
| 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 |
| url | https://doi.org/10.1002/psp4.12906 |
| work_keys_str_mv | AT efthymiosmanolis usingmechanisticmodelstosupportdevelopmentofcomplexgenericdrugproductseuropeanmedicinesagencyperspective AT alfredogarciaarieta usingmechanisticmodelstosupportdevelopmentofcomplexgenericdrugproductseuropeanmedicinesagencyperspective AT anderslindahl usingmechanisticmodelstosupportdevelopmentofcomplexgenericdrugproductseuropeanmedicinesagencyperspective AT evangeloskotzagiorgis usingmechanisticmodelstosupportdevelopmentofcomplexgenericdrugproductseuropeanmedicinesagencyperspective AT jobstlimberg usingmechanisticmodelstosupportdevelopmentofcomplexgenericdrugproductseuropeanmedicinesagencyperspective AT øyvindholte usingmechanisticmodelstosupportdevelopmentofcomplexgenericdrugproductseuropeanmedicinesagencyperspective AT paulopaixao usingmechanisticmodelstosupportdevelopmentofcomplexgenericdrugproductseuropeanmedicinesagencyperspective AT carolienversantvoort usingmechanisticmodelstosupportdevelopmentofcomplexgenericdrugproductseuropeanmedicinesagencyperspective AT floramusuambatshinanu usingmechanisticmodelstosupportdevelopmentofcomplexgenericdrugproductseuropeanmedicinesagencyperspective AT kevinblake usingmechanisticmodelstosupportdevelopmentofcomplexgenericdrugproductseuropeanmedicinesagencyperspective AT michielvandenheuvel usingmechanisticmodelstosupportdevelopmentofcomplexgenericdrugproductseuropeanmedicinesagencyperspective |