Flow cytometry as an integrative method for the evaluation of vaccine immunogenicity: A validation approach

Author:

Gianchecchi Elena,Torelli Alessandro,Piu Pietro,Bonifazi Carolina,Ganfini Luisa,Montomoli Emanuele

Publisher

Elsevier BV

Subject

Biochemistry,Biophysics

Reference21 articles.

1. Guideline on Bioanalytical Method Validation (EMEA/CHMP/EWP/192217/2009 Rev 1 Corr.2;EMA,2012

2. US FDA. Context of Use. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/BiomarkerQualificationProgram/ucm535395.html. Accessed on 02 May 2022.

3. Medical Laboratories – Requirements for Quality and Competence,2014

4. Flow cytometry method validation protocols;Selliah;Curr. Protoc. Cytom.,2019

5. Recommendations for the validation of flow cytometric testing during drug development: II assays;O'Hara;J. Immunol. Methods,2011

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