Global harmonization of vaccine testing requirements: Making elimination of the ATT and TABST a concrete global achievement.
Biologicals
; 63: 101-105, 2020 Jan.
Article
em En
| MEDLINE
| ID: mdl-31699501
ABSTRACT
This one-day symposium organized by Humane Society International (HSI) brought together 18 international experts from Argentina, Brazil, China, Europe, India, Russia, South Africa and the United States to discuss the elimination of the abnormal toxicity test (ATT) from the testing requirements for human vaccines as well as the target animal batch safety test (TABST) and the laboratory animal batch safety test (LABST) for veterinary vaccines. Participants reported on country-specific regulatory requirements and, where present, the perspectives on waiver and elimination of those tests. In addition, the attendees, with HSI in the role of facilitator, moved to define the barriers to the complete elimination or waiving of these tests. This report expounds the outcomes of the symposium, and introduces a proposed roadmap - populated with country specific activities - for the elimination of these tests.
Palavras-chave
Texto completo:
1
Bases de dados:
MEDLINE
Assunto principal:
Controle de Qualidade
/
Vacinas
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Testes de Toxicidade
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Alternativas aos Testes com Animais
Limite:
Animals
Idioma:
En
Revista:
Biologicals
Assunto da revista:
ALERGIA E IMUNOLOGIA
Ano de publicação:
2020
Tipo de documento:
Article