Facial reconstruction

Search LJMU Research Online

Browse Repository | Browse E-Theses

Internationalizationof Read-Across as a Validated New Approach Method (NAM) for Regulatory Toxicology

Rovida, C, Barton-Maclaren, T, Benfenati, E, Cronin, MTD, Caloni, F, Chandrasekera, C, Chesne, C, de Knecht, J, Dietrich, DR, Escher, SE, Fitzpatrick, S, Flannery, B, Herzler, M, Hougaard Bennekou, S, Hubesch, B, Kamp, H, Kisitu, J, Kleinstreuer, N, Kovarich, S, Leist, M , Maertens, A, Nugent, K, Pallocca, G, Pastor, M, Patlewicz, G, Pavana, M, Presgrave, O, Smirnova, L, Schwarz, M, Yamada, T and Hartung, T (2020) Internationalizationof Read-Across as a Validated New Approach Method (NAM) for Regulatory Toxicology. ALTEX : Alternativen zu Tierexperimenten. ISSN 0946-7785 (Accepted)

[img] Text
Internationalizationof Read-Across as a Validated New Approach Method (NAM) for Regulatory Toxicology.pdf - Accepted Version
Restricted to Repository staff only
Available under License Creative Commons Attribution.

Download (2MB)

Abstract

Read-across (RAx) translates available information from well-characterized chemicals tothe 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 (e.g. EU-REACH) already allow this procedure to be used to waive new in vivotests. 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 optimisation to allowa 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 ADMEthat may differ between source and target. The use of new approach methodologies (NAM) was discussed as one of the most important innovations to improve the acceptability of RAx. At present, NAM data may be used to confirm chemical and toxicological similarity. In the future, the use of NAM may be broadened to fully characterize the hazard and toxicokinetic properties of RAx compounds. Concerning available guidance, documents on Good Read-Across Practice (GRAP) and on best practices to perform and evaluatethe RAx process were identified. Here, in particular the RAx guidance, being worked out by the European Commission’s H2020 project EU-ToxRisk, together with many external partners with regulatory experience, is given.

Item Type: Article
Uncontrolled Keywords: 07 Agricultural and Veterinary Sciences, 11 Medical and Health Sciences
Subjects: R Medicine > RM Therapeutics. Pharmacology
R Medicine > RZ Other systems of medicine
Divisions: Pharmacy & Biomolecular Sciences
Publisher: Springer
Date Deposited: 01 May 2020 09:32
Last Modified: 01 May 2020 09:45
DOI or Identification number: 10.14573/altex.1912181
URI: http://researchonline.ljmu.ac.uk/id/eprint/12865

Actions (login required)

View Item View Item