Neutralizing Antibody Validation Testing and Reporting Harmonization

Evolving immunogenicity assay performance expectations and a lack of harmonized neutralizing antibody validation testing and reporting tools have resulted in significant time spent by health authorities and sponsors on resolving filing queries. A team of experts within the American Association of Ph...

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Veröffentlicht in:	The AAPS journal 2023-07, Vol.25 (4), p.69-69, Article 69
Hauptverfasser:	Myler, Heather, Pedras-Vasconcelos, João, Lester, Todd, Civoli, Francesca, Xu, Weifeng, Wu, Bonnie, Vainshtein, Inna, Luo, Linlin, Hassanein, Mohamed, Liu, Susana, Ramaswamy, Swarna Suba, Mora, Johanna, Pennucci, Jason, McCush, Fred, Lavelle, Amy, Jani, Darshana, Ambakhutwala, Angela, Baltrukonis, Daniel, Barker, Breann, Carmean, Rebecca, Chung, Shan, Dai, Sheng, DeWall, Stephen, Dholakiya, Sanjay L., Dodge, Robert, Finco, Deborah, Yan, Haoheng, Hays, Amanda, Hu, Zheng, Inzano, Cynthia, Kamen, Lynn, Lai, Ching-Ha, Meyer, Erik, Nelson, Robert, Paudel, Amrit, Phillips, Kelli, Poupart, Marie-Eve, Qu, Qiang, Abhari, Mohsen Rajabi, Ryding, Janka, Sheldon, Curtis, Spriggs, Franklin, Warrino, Dominic, Wu, Yuling, Yang, Lin, Pasas-Farmer, Stephanie
Format:	Artikel
Sprache:	eng
Schlagworte:	Antibodies Antibodies, Neutralizing Biochemistry Biomedical and Life Sciences Biomedicine Biotechnology Drug Tolerance Health aspects Pharmaceutical Preparations Pharmacology/Toxicology Pharmacy Viral antibodies White Paper
Online-Zugang:	Volltext
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