Anti-drug Antibody Validation Testing and Reporting Harmonization

Evolving immunogenicity assay performance expectations and a lack of harmonized anti-drug antibody validation testing and reporting tools have resulted in significant time spent by health authorities and sponsors on resolving filing queries. Following debate at the American Association of Pharmaceut...

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Detalles Bibliográficos
Autores principales: Myler, Heather, Pedras-Vasconcelos, João, Phillips, Kelli, Hottenstein, Charles Scott, Chamberlain, Paul, Devanaryan, Viswanath, Gleason, Carol, Goodman, Joanne, Manning, Marta Starcevic, Purushothama, Shobha, Richards, Susan, Shen, Honglue, Zoghbi, Jad, Amaravadi, Lakshmi, Barger, Troy, Bowen, Steven, Bowsher, Ronald R., Clements-Egan, Adrienne, Geng, Dong, Goletz, Theresa J., Gunn, George R., Hallett, William, Hodsdon, Michael E., Janelsins, Brian M., Jawa, Vibha, Kamondi, Szilard, Kirshner, Susan, Kramer, Daniel, Liang, Meina, Lindley, Kathryn, Liu, Susana, Liu, ZhenZhen, McNally, Jim, Mikulskis, Alvydas, Nelson, Robert, Ahbari, Mohsen Rajabi, Qu, Qiang, Ruppel, Jane, Snoeck, Veerle, Song, An, Yan, Haoheng, Ware, Mark
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2021
Materias:
White Paper
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8816448/
https://www.ncbi.nlm.nih.gov/pubmed/34853961
http://dx.doi.org/10.1208/s12248-021-00649-y

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8816448/
https://www.ncbi.nlm.nih.gov/pubmed/34853961
http://dx.doi.org/10.1208/s12248-021-00649-y

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