Rational arguments for regulatory acceptance of consistency testing: benefits of non-animal testing over <i>in vivo</i> release testing of vaccines-Reference-Cited by-同舟云学术

Rational arguments for regulatory acceptance of consistency testing: benefits of non-animal testing over in vivo release testing of vaccines

Published:2023-04-19 Issue:1 Volume:22 Page:369-377
ISSN:1476-0584
Container-title:Expert Review of Vaccines
language:en
Short-container-title:Expert Review of Vaccines

Author:

Hoefnagel Marcel H.N.¹,Stickings Paul²,Smith Dean³,Jungbäck Carmen⁴,Van Molle Wim⁵,Tesolin Lorenzo⁵

Affiliation:

1. Quality Department, CBG-MEB (Medicines Evaluation Board), Utrecht, The Netherlands

2. Medicines and Healthcare products Regulatory Agency, Hertfordshire, UK

3. Bacterial and combination vaccines division, Health Canada, Ontario, Canada

4. International Association for Biological Standardization for Europe (IABS), Lyon, France

5. Quality of Vaccines and Blood Products, Sciensano, Brussels, Belgium

Funder

Innovative Medicines Initiative

Horizon 2020

Publisher

Informa UK Limited

Subject

Drug Discovery,Pharmacology,Molecular Medicine,Immunology

Link

https://www.tandfonline.com/doi/pdf/10.1080/14760584.2023.2198601

Reference71 articles.

1. International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. ICH Q8(R2) on pharmaceutical development. 2009. https://www.ich.org/page/quality-guidelines. (Accessed 25 Feb 2023)

2. The consistency approach for quality control of vaccines – A strategy to improve quality control and implement 3Rs

3. The vaccines consistency approach project: an EPAA initiative;De Mattia F;Pharmeur Bio Sci Notes,2015

4. Potency testing of veterinary vaccines: The way from in vivo to in vitro

5. Overcoming scientific barriers in the transition from in vivo to non-animal batch testing of human and veterinary vaccines

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