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Updated: Mar 14, 2026

High Content Screening Analysis to Evaluate the Toxicological Effects of Harmful and Potentially Harmful Constituents HPHC
Published on: May 10, 2016
Predicting toxicities in humans by nonclinical safety testing: an update with particular reference to anticancer
Varun Ahuja1, Sanjay Bokan1, Sharad Sharma1
1Drug Safety Assessment, Novel Drug Discovery and Development, Lupin Limited (Research Park), 46A/47A, Nande Village, Taluka-Mulshi, Pune 412115, India.
Abstract:
The sensitivity of the various preclinical models used to predict toxicity in humans varies. In this review, we analyze the various models used to predict safety in drug discovery and development with a view to understanding their translational value in humans. Twenty recently approved anticancer drugs were studied and the available nonclinical and clinical adverse effects information available from the US Food and Drug Administration (FDA) was analyzed. We found that gastrointestinal and hematopoietic toxicities in humans were predicted to the maximum extent by nonclinical models, whereas respiratory, integumentary, renal, nervous, hepatic, and cardiovascular were moderately predicted. Ocular, endocrine, and musculoskeletal toxicities were poorly predicted while lymphatic and immune toxicities were difficult to predict.
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