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.
EuroGTPII: a tool to assess risk, safety and efficacy of substances of human origin
ELISABETTA MARTON
2019
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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