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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...
| Autores principales: | , , , , , , , , , , , , , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
Academic Press
2018
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| Materias: | |
| 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 |
| _version_ | 1783378445594525696 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Halder, Marlies |
| collection | PubMed |
| description | 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. |
| format | Online Article Text |
| id | pubmed-6278876 |
| institution | National Center for Biotechnology Information |
| language | English |
| publishDate | 2018 |
| publisher | Academic Press |
| record_format | MEDLINE/PubMed |
| spelling | pubmed-62788762018-12-13 Recommendations of the VAC2VAC workshop on the design of multi-centre validation studies 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 Biologicals Article 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. Academic Press 2018-03 /pmc/articles/PMC6278876/ /pubmed/29395838 http://dx.doi.org/10.1016/j.biologicals.2018.01.003 Text en . |
| spellingShingle | Article 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 Recommendations of the VAC2VAC workshop on the design of multi-centre validation studies |
| title | Recommendations of the VAC2VAC workshop on the design of
multi-centre validation studies |
| title_full | Recommendations of the VAC2VAC workshop on the design of
multi-centre validation studies |
| title_fullStr | Recommendations of the VAC2VAC workshop on the design of
multi-centre validation studies |
| title_full_unstemmed | Recommendations of the VAC2VAC workshop on the design of
multi-centre validation studies |
| title_short | Recommendations of the VAC2VAC workshop on the design of
multi-centre validation studies |
| title_sort | recommendations of the vac2vac workshop on the design of
multi-centre validation studies |
| topic | Article |
| url | 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 |
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