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

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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.

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Trias, E., Lomas, R., Tabera, J., Piteira, A. R., Tilleman, K., Casaroli-Marano, R. P., & Chandrasekar, A. (2020, April 21). EuroGTP II: A tool to assess risk, safety and efficacy of substances of human origin. International Journal for Quality in Health Care. Oxford University Press. https://doi.org/10.1093/intqhc/mzz048

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