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Quality changes to approved biotherapeutic product: Simulated case studies on reporting categories & supporting data requirements
Changes are essential for the continual improvement of the manufacturing process and for maintaining state-of-the-art controls on biotherapeutic products and such changes often need to be implemented after the product has been approved. WHO guidelines on procedures and data requirement for changes t...
| Autores principales: | , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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Academic Press
2019
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6863427/ https://www.ncbi.nlm.nih.gov/pubmed/31668453 http://dx.doi.org/10.1016/j.biologicals.2019.10.008 |