Determining the value of subchronic or chronic animal toxicity testing in identifying new target organ findings.

Paul Baldrick¹

¹Scientific Advisory Services, Charles River Laboratories, High Peak Business Park, Buxton Road, Chinley, High Peak, SK23 6FJ, United Kingdom. Electronic address: Paul.Baldrick@crl.com.

PubMed DOI

Abstract

Toxicity studies supporting FIH clinical entry were compared with those of 13-week (subchronic) and ≥26 weeks (chronic) duration for 38 small molecule (non-oncology), 58 small molecule oncology and 13 biological drug candidates. New target organs, seen as new findings, occurred in subchronic studies in rodents and non-rodents for 32% and 29% small molecule (non-oncology) drug candidates, respectiv…

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