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

Esteve Trias | Zendy; Richard Lomas | Zendy; Jaime Tabera | Zendy; Ana Rita Piteira | Zendy; Kelly Tilleman | Zendy; Ricardo P. CasaroliMarano | Zendy; Akila Chandrasekar | Zendy; EuroGTP II Study Group | Zendy

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

Author(s) -

Esteve Trias,

Richard Lomas,

Jaime Tabera,

Ana Rita Piteira,

Kelly Tilleman,

Ricardo P. CasaroliMarano,

Akila Chandrasekar,

EuroGTP II Study Group

Publication year - 2019

Publication title -

international journal for quality in health care

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 0.769

H-Index - 94

eISSN - 1464-3677

pISSN - 1353-4505

DOI - 10.1093/intqhc/mzz048

Subject(s) - novelty , risk analysis (engineering) , process (computing) , product (mathematics) , computer science , medicine , psychology , mathematics , social psychology , operating system , geometry

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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