Beilmann, M, Boonen, H, Czich, A, Dear, G, Hewitt, P, Mow, T, Newham, P, Oinonen, T, Pognan, F, Roth, A, Valentin, J-P, Van Goethem, F, Weaver, RJ, Birk, B, Boyer, S, Caloni, F, Chen, AE, Corvi, R, Cronin, MTD, Daneshian, M et al, Ewart, LC, Fitzgerald, RE, Hamilton, GA, Hartung, T, Kangas, JD, Kramer, NI, Leist, M, Marx, U, Polak, S, Rovida, C, Testai, E, Van der Water, B, Vulto, P and Steger-Hartmann, T (2018) Optimizing drug discovery by Investigative Toxicology: Current and future trends. Altex-Alternatives to Animal Experimentation. ISSN 1868-596X

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Abstract

Investigative Toxicology describes the de-risking and mechanistic elucidation of toxicities, supporting early safety decisions in the pharmaceutical industry. Recently, Investigative Toxicology has contributed to a shift in pharmaceutical toxicology, from a descriptive to an evidence-based, mechanistic discipline. This was triggered by high costs and low throughput of Good Laboratory Practice in vivo studies, and increasing demands for adhering to the 3R (Replacement, Reduction and Refinement) principles of animal welfare. Outside the boundaries of regulatory toxicology, Investigative Toxicology has the flexibility to embrace new technologies, enhancing translational steps from in silico, in vitro to in vivo mechanistic understanding to eventually predict human response. One major goal of Investigative Toxicology is improving preclinical decisions, which coincides with the concept of animal-free safety testing. Currently, compounds under preclinical development are being discarded due to the use of inappropriate animal models. Progress in Investigative Toxicology could lead to humanized in vitro test systems and the development of medicines less reliant on animal tests. To advance this field a group of 14 European-based leaders from the pharmaceutical industry founded the Investigative Toxicology Leaders Forum (ITLF), an open, non-exclusive and pre-competitive group that shares knowledge and experience. The ITLF collaborated with the Centre for Alternatives to Animal Testing Europe (CAAT-Europe) to organize an "Investigative Toxicology Think-Tank", which aimed to enhance the interaction with experts from academia and regulatory bodies in the field. Summarizing the topics and discussion of the workshop, this article highlights Investigative Toxicology's position by identifying key challenges and perspectives.

Item Type:	Article
Uncontrolled Keywords:	07 Agricultural and Veterinary Sciences, 11 Medical and Health Sciences
Subjects:	R Medicine > RM Therapeutics. Pharmacology
Divisions:	Pharmacy & Biomolecular Sciences
Publisher:	ALTEX Edition
Related URLs:	https://www.ncbi.nlm.nih.gov/pubmed/30570669
Date Deposited:	21 Jan 2019 11:59
Last Modified:	03 Sep 2021 23:40
DOI or ID number:	10.14573/altex.1808181
URI:	https://researchonline.ljmu.ac.uk/id/eprint/9971

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