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Expert Review of Vaccines Volume 22, 2023 - Issue 1
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Perspective

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

Marcel H.N. Hoefnagela Quality Department, CBG-MEB (Medicines Evaluation Board), Utrecht, The NetherlandsCorrespondence[email protected]
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,
Paul Stickingsb Medicines and Healthcare products Regulatory Agency, Hertfordshire, UKView further author information
,
Dean Smithc Bacterial and combination vaccines division, Health Canada, Ontario, CanadaView further author information
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Carmen Jungbäckd International Association for Biological Standardization for Europe (IABS), Lyon, FranceView further author information
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Wim Van Mollee Quality of Vaccines and Blood Products, Sciensano, Brussels, BelgiumView further author information
&
Lorenzo Tesoline Quality of Vaccines and Blood Products, Sciensano, Brussels, BelgiumView further author information
Pages 369-377 | Received 27 Dec 2022, Accepted 30 Mar 2023, Published online: 19 Apr 2023

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