Research progress on substitution of in vivo method(s) by in vitro method(s) for human vaccine potency assays

Author:

Zhang Xuanxuan1,Wu Xing1,He Qian1,Wang Junzhi1,Mao Qunying1,Liang Zhenglun1,Xu Miao1

Affiliation:

1. Institute of Biological Products, Division of Hepatitis and Enterovirus Vaccines, National Institutes for Food and Drug Control, Beijing, China

Funder

CAMS Innovation Fund for Medical Sciences

Publisher

Informa UK Limited

Subject

Drug Discovery,Pharmacology,Molecular Medicine,Immunology

Reference76 articles.

1. Vaccines Licensed for Use in the United States [Internet]. Washington D.C: FDA [2022 November 30] Available from: https://www.fda.gov/vaccines-blood-biologics/vaccines/vaccines-licensed-use-united-states

2. ChPC. Pharmacopoeia of the People’s Republic of China (VolIII). Beijing: China Medical Science Press; 2020.

3. EDQM. . European Pharmacopoeia. 10.0th ed. Strasbourgh France: European Department for the Quality of Medicines. 2019.

4. Vaccine Potency Assays

5. Principles of vaccine potency assays

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