Standardized neutralization antibody analytical procedure for clinical samples based on the AQbD concept-Reference-Cited by-全球学者库

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Standardized neutralization antibody analytical procedure for clinical samples based on the AQbD concept

Published:2023-04-28 Issue:1 Volume:8 Page:
ISSN:2059-3635
Container-title:Signal Transduction and Targeted Therapy
language:en
Short-container-title:Sig Transduct Target Ther

Author:

Liu Jianyang,Bai Yu,Liu Mingchen,Tan Dejiang,Li Jing,Wang Zhongfang,Liang Zhenglun,Xu Miao,Wang Junzhi,Mao Qunying

Funder

This study was supported by the Emergency Key Program (NO. EKPG21-30-1) of Guangzhou Laboratory, China.

Publisher

Springer Science and Business Media LLC

Subject

Cancer Research,Genetics

Link

https://www.nature.com/articles/s41392-023-01389-5.pdf

Reference5 articles.

1. Watson, O. J. et al. Global impact of the first year of COVID-19 vaccination: a mathematical modelling study. Lancet Infect. Dis. 22, 1293–1302 (2022).

2. Khoury, D. S. et al. Ntab levels are highly predictive of immune protection from symptomatic SARS-CoV-2 infection. Nat. Med. 27, 1205–1211 (2021).

3. Liu, J. et al. Considerations for the feasibility of neutralizing antibodies as a surrogate endpoint for COVID-19 vaccines. Front. Immunol. 13, 814365 (2022).

4. Pharmacopoeia, U. S. Analytical procedure life cycle. https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/usp-nf-notices/gc-1220-pre-post-20210924.pdf. (2022).

5. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Analytical procedure development Q14. https://database.ich.org/sites/default/files/ICH_Q14_Document_Step2_Guideline_2022_0324.pdf. (2022).

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