EuroGTP II: a tool to assess risk, safety and efficacy of substances of human origin
Por:
Trias, E, Lomas, R, Tabera, J, Piteira, AR, Tilleman, K, Casaroli-Marano, RP, Chandrasekar, A
Publicada:
1 feb 2020
Resumen:
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.
Filiaciones:
Trias, E:
Barcelona Tissue Bank, Banc Sang & Teixits BST, Barcelona, Spain
Lomas, R:
Nat Hlth Serv Blood & Transplant NHSBT, Liverpool, Merseyside, England
Tabera, J:
Barcelona Tissue Bank, Banc Sang & Teixits BST, Barcelona, Spain
Piteira, AR:
Barcelona Tissue Bank, Banc Sang & Teixits BST, Barcelona, Spain
Tilleman, K:
Ghent Univ Hosp, Dept Reprod Med, Ghent, Belgium
Casaroli-Marano, RP:
Barcelona Tissue Bank, Banc Sang & Teixits BST, Barcelona, Spain
Chandrasekar, A:
Nat Hlth Serv Blood & Transplant NHSBT, Liverpool, Merseyside, England
Bronze
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