Recommendations of the VAC2VAC workshop on the design of multi-centre validation studies

Within the Innovative Medicines Initiative 2 (IMI 2) project VAC2VAC (Vaccine batch to vaccine batch comparison by consistency testing), a workshop has been organised to discuss ways of improving the design of multi-centre validation studies and use the data generated for product-specific validation...

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Detalles Bibliográficos
Autores principales: Halder, Marlies, Depraetere, Hilde, Delannois, Frédérique, Akkermans, Arnoud, Behr-Gross, Marie-Emmanuelle, Bruysters, Martijn, Dierick, Jean-François, Jungbäck, Carmen, Kross, Imke, Metz, Bernard, Pennings, Jeroen, Rigsby, Peter, Riou, Patrice, Balks, Elisabeth, Dobly, Alexandre, Leroy, Odile, Stirling, Catrina
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Academic Press 2018
Materias:
Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6278876/
https://www.ncbi.nlm.nih.gov/pubmed/29395838
http://dx.doi.org/10.1016/j.biologicals.2018.01.003
Descripción
Sumario:Within the Innovative Medicines Initiative 2 (IMI 2) project VAC2VAC (Vaccine batch to vaccine batch comparison by consistency testing), a workshop has been organised to discuss ways of improving the design of multi-centre validation studies and use the data generated for product-specific validation purposes. Moreover, aspects of validation within the consistency approach context were addressed. This report summarises the discussions and outlines the conclusions and recommendations agreed on by the workshop participants.

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