Alternative potency tests for quality control of immunobiologicals: a critical review of the validation approach

Alternative potency tests for quality control of immunobiologicals: a critical review of the validation approach

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Introduction: In addition to low reproducibility, in vivo potency tests used in the quality control of immunobiological products require too many animals, causing them significant pain and suffering. In the last decades, many studies have been conducted to validate alternative methods for quality co...

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Bibliographic Details
Main Authors: Wildeberg Cal Moreira, Nathalia de Souza Machado, Jéssica Ferreira de Souza Freitas, Antônio Eugênio Castro Cardoso de Almeida, Wlamir Correa de Moura
Format: Article
Language:English
Published: Fundação Oswaldo Cruz (FIOCRUZ) 2020-02-01
Series:Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia
Subjects:
Alternative Methods
Immunobiologicals
Potency Test
Validation Approach
Online Access:https://visaemdebate-v2.incqs.fiocruz.br/index.php/visaemdebate/article/view/1259

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https://visaemdebate-v2.incqs.fiocruz.br/index.php/visaemdebate/article/view/1259

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