ICH Q12: innovadora y controvertida (parte 2)

This work has been published in two parts. In the first, the conceptual framework of the ICH and more specifically of the ICH Q12 was reviewed. In this second, and last, the regulatory and enabling tools of the ICH Q12 are reviewed, which is complemented by a practical part or 'survey' car...

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Detalles Bibliográficos
Autores: Monsonís Centelles, Laura, García Montoya, Encarna
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2021
País:España
Institución:Universidad de Barcelona
Repositorio:Dipòsit Digital de la UB
OAI Identifier:oai:diposit.ub.edu:2445/183451
Acceso en línea:https://hdl.handle.net/2445/183451
Access Level:acceso abierto
Palabra clave:Tecnologia farmacèutica
Comprimits (Medicina)
Desenvolupament de medicaments
Pharmaceutical technology
Tablets (Medicine)
Drug development
Descripción
Sumario:This work has been published in two parts. In the first, the conceptual framework of the ICH and more specifically of the ICH Q12 was reviewed. In this second, and last, the regulatory and enabling tools of the ICH Q12 are reviewed, which is complemented by a practical part or 'survey' carried out with some professionals in the pharmaceutical industry, although the sample is very small and cannot be generalized, It is important to realize that more information and training on it is necessary at this time for its effective application.