Global harmonization of vaccine testing requirements: Making elimination of the ATT and TABST a concrete global achievement
| Autor: | Marianne Kaashoek, Geetha Srinivas, Marlies Halder, Derek Litthauer, Sunil Goel, Troy Seidle, Marion F. Gruber, Arthur Leonardo Lopes da Silva, Dimitriy Yakunin, Hongtao Jin, Laura Viviani, Lukas Bruckner, Elena Sakanyan, Gautam Sanyal, Joris Vandeputte, Klaus Cussler, Patricia Aprea |
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| Rok vydání: | 2019 |
| Předmět: |
0301 basic medicine
Quality Control Bioengineering Harmonization Animal Testing Alternatives Applied Microbiology and Biotechnology 03 medical and health sciences 0302 clinical medicine Political science Toxicity Tests Vaccine Testing Animals 030212 general & internal medicine health care economics and organizations Pharmacology Vaccines General Immunology and Microbiology business.industry General Medicine Public relations Waiver Test (assessment) 030104 developmental biology Facilitator business Biotechnology |
| Zdroj: | Biologicals : journal of the International Association of Biological Standardization. 63 |
| ISSN: | 1095-8320 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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