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Drug Discov Today. 2014 Aug;19(8):1131-6. doi: 10.1016/j.drudis.2013.12.008. Epub 2013 Dec 22.

Exploratory toxicology as an integrated part of drug discovery. Part I: Why and how.

Author information

1
Department of Exploratory Toxicology, H. Lundbeck A/S, Ottiliavej 9, DK-2500 Valby, Denmark.
2
Department of Exploratory Toxicology, H. Lundbeck A/S, Ottiliavej 9, DK-2500 Valby, Denmark. Electronic address: tmo@lundbeck.com.

Abstract

Toxicity and clinical safety have major impact on drug development success. Moving toxicological studies into earlier phases of the R&D chain prevents drug candidates with a safety risk from entering clinical development. However, to identify candidates without such risk, safety has to be designed actively. Therefore, we argue that toxicology should be fully integrated into the discovery process. We describe our strategy, including safety assessment of novel targets, selection of chemical series without inherent liabilities, designing out risk factors and profiling of candidates, and we discuss considerations regarding what to screen for. We aim to provide timely go/no-go decisions (fail early) and direction to the discovery teams, by steering away from safety risk (showing what will not fail).

PMID:
24368175
DOI:
10.1016/j.drudis.2013.12.008
[Indexed for MEDLINE]

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