학술논문
2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs (Part 1A - Recommendations on Mass Spectrometry, Chromatography and Sample Preparation, Novel Technologies, Novel Modalities, and Novel Challenges, ICH M10 BMV Guideline & Global Harmonization Part 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine)
Document Type
Review
Author
Szapacs, M.; Spellman, D.; Goykhman, D.; Lassman, M.; Woolf, E.; Verburg, E.; Cunliffe, J.; Jian, W.; Carleton, K.; Kaur, S.; Casavant, E.; Saad, O.; Williams, K.; Kellie, J.; Mehl, J.; Sikorski, T.; Fang, K.; Mayer, A.; Yang, E.; Li, W.; Fu, Y.; Qian, M.; Qiu, X.; Wang, Y.; Kar, S.; Sirtori, F.R.; Rosenbaum, A.I.; Huang, Y.; Surapaneni, S.; Xue, Y.; Zheng, N.; Wang, J.; Wilson, A.; Zhang, J.; Dasgupta, A.; Abhari, M.R.; Cho, S.J.; Du, X.; Lu, Y.; Wang, Y.-M.; Yang, L.; Bandukwala, A.; Maher, K.; Brodsky, E.; Kirshner, S.; Manangeeswaran, M.; Maxfield, K.; Pedras-Vasconcelos, J.; Thacker, S.; Verthelyi, D.; Wagner, L.; Zhou, L.; Post, N.; Chen, L.; Huang, M.; Palackal, N.; Ji, A.; Johnson, J.; Li, J.; Sarvaiya, H.; Tao, L.; Yuan, L.; Ishii-Watabe, A.; Saito, Y.; Yamamoto, T.; Mendes Fernandes, D.N.; Bower, J.; Burns, C.; Vinter, S.; Hopper, S.; Cludts, I.; Wadhwa, M.; Fjording, M.; Garofolo, F.; Kavetska, O.; Kossary, E.; Salha, D.; Thomas, E.; Verhaeghe, T.; Wan, K.; Xu, J.; Irwin, C.; Joseph, J.; Tounekti, O.; Zhang, L.; Solstad, T.
Source
In: Bioanalysis . (Bioanalysis, 1 August 2023, 15(16):955-1016)
Subject
Language
English
ISSN
17576199
17576180
17576180