作者
Costanza Rovida, Tara Barton-Maclaren, Emilio Benfenati, Francesca Caloni, P Charukeshi Chandrasekera, Christophe Chesne, Mark TD Cronin, Joop De Knecht, Daniel R Dietrich, Sylvia E Escher, Suzanne Fitzpatrick, Brenna Flannery, Matthias Herzler, Susanne Hougaard Bennekou, Bruno Hubesch, Hennicke Kamp, Jaffar Kisitu, Nicole Kleinstreuer, Simona Kovarich, Marcel Leist, Alexandra Maertens, Kerry Nugent, Giorgia Pallocca, Manuel Pastor, Grace Patlewicz, Manuela Pavan, Octavio Presgrave, Lena Smirnova, Michael Schwarz, Takashi Yamada, Thomas Hartung
发表日期
2020
期刊
Altex
卷号
37
期号
4
页码范围
579
出版商
NIH Public Access
简介
Read-across (RAx) translates available information from well-characterized chemicals to a substance for which there is a toxicological data gap. The OECD is working on case studies to probe general applicability of RAx, and several regulations (eg, EU-REACH) already allow this procedure to be used to waive new in vivo tests. The decision to prepare a review on the state of the art of RAx as a tool for risk assessment for regulatory purposes was taken during a workshop with international experts in Ranco, Italy in July 2018. Three major issues were identified that need optimization to allow a higher regulatory acceptance rate of the RAx procedure:(i) the definition of similarity of source and target,(ii) the translation of biological/toxicological activity of source to target in the RAx procedure, and (iii) how to deal with issues of ADME that may differ between source and target. The use of new approach methodologies …
学术搜索中的文章
C Rovida, T Barton-Maclaren, E Benfenati, F Caloni… - Altex, 2020