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Drug Discov Today. 2014 Mar;19(3):341-7. doi: 10.1016/j.drudis.2013.11.014. Epub 2013 Nov 21.

Reducing attrition in drug development: smart loading preclinical safety assessment.

Author information

1
Drug Safety and Metabolism, AstraZeneca, Alderley Park, Macclesfield, SK10 4TG, UK. Electronic address: ruth.roberts@astrazeneca.com.
2
Drug Safety and Metabolism, AstraZeneca, Alderley Park, Macclesfield, SK10 4TG, UK.

Abstract

Entry into the crucial preclinical good laboratory practice (GLP) stage of toxicology testing triggers significant R&D investment yet >20% of AstraZeneca's potential new medicines have been stopped for safety reasons in this GLP phase alone. How could we avoid at least some of these costly failures? An analysis of historical toxicities that caused stopping ('stopping toxicities') showed that >50% were attributable to target organ toxicities emerging within 2 weeks of repeat dosing or to acute cardiovascular risks. By frontloading 2-week repeat-dose toxicity studies and a comprehensive assessment of cardiovascular safety, we anticipate a potential 50% reduction in attrition in the GLP phase. This will reduce animal use overall, save significant R&D costs and improve drug pipeline quality.

PMID:
24269835
DOI:
10.1016/j.drudis.2013.11.014
[Indexed for MEDLINE]
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