학술논문
2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback (Part 2A – Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation Part 2B – Regulatory Agencies’ Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine)
Document Type
Article
Author
Spitz, S.; Zhang, Y.; Fischer, S.; Elliott, R.; Peng, K.; Yan, W.; Green, C.; Robert, A.H.; Sommer, U.; Vitaliti, A.; Amaravadi, L.; Bandukwala, A.; Wang, Y.-M.; Haidar, S.; Abhari, M.R.; Maher, K.; Dandamudi, S.; Dasgupta, A.; Faustino, P.; Mirza, T.; Shakleya, D.; Tampal, N.; Zhang, J.; Kirshner, S.; Pedras-Vasconcelos, J.; Shen, M.; Verthelyi, D.; Yan, H.; Eck, S.; Garofolo, F.; Islam, R.; Jordan, G.; Neff, F.; King, L.; McGuire, K.; Sumner, G.; Andisik, M.; Palackal, N.; Saito, Y.; Ishii-Watabe, A.; Terry, L.; Grimaldi, C.; Joyce, A.; Araya, M.; Azadeh, M.; Estevam, J.; Baltrukonis, D.; Kumar, S.; Mayer, A.; Junker, F.; Teixeira, P.C.; Palmer, R.; Satterwhite, C.; Savoie, N.; Kar, S.; Soo, C.; Edmison, A.; Stojdl, S.; Cherry, E.; Siggers, R.; Zhang, L.; Vinter, S.; McGuinness, M.; Exley, A.; Welink, J.; Bertholet, S.; Nuti, S.; Dakappagari, N.; Sarikonda, S.; Tangri, S.; Gonneau, C.; Lanham, D.; Patti-Diaz, L.; McCausland, M.; Decman, V.; Hedrick, M.; Hopkins, G.; Wnek, R.; Santos, G.M.L.; Cludts, I.; Solstad, T.
Source
In: Bioanalysis . (Bioanalysis, March 2021, 13(5):295-361)
Subject
Language
English
ISSN
17576199
17576180
17576180