EuroGTP II: a tool to assess risk, safety and efficacy of substances of human origin

Abstract A systematic methodology, able to assess risk and predict clinical safety and efficacy of Substances of Human Origin’ (SoHO) has been developed. The model consists of a risk based approach taking into account factors such as novelty of the product, preparation process, clinical indication,...

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Bibliographic Details
Published in:International journal for quality in health care 2020-04, Vol.32 (1), p.80-84
Main Authors: Trias, Esteve, Lomas, Richard, Tabera, Jaime, Piteira, A Rita, Tilleman, Kelly, Casaroli-Marano, Ricardo P, Chandrasekar, Akila
Format: Article
Language:English
Subjects:
Cell- and Tissue-Based Therapy - standards
European Union
Humans
Risk Assessment - methods
Risk Factors
Translational Medical Research
Treatment Outcome
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Summary:Abstract A systematic methodology, able to assess risk and predict clinical safety and efficacy of Substances of Human Origin’ (SoHO) has been developed. The model consists of a risk based approach taking into account factors such as novelty of the product, preparation process, clinical indication, and its technical complexity.
ISSN:1353-4505
1464-3677
DOI:10.1093/intqhc/mzz048