Limitations of Animal Studies for Predicting Toxicity in Clinical Trials

Limitations of Animal Studies for Predicting Toxicity in Clinical Trials

Summary: Animal testing is used in pharmaceutical and industrial research to predict human toxicity, and yet analysis suggests that animal models are poor predictors of drug safety in humans. The cost of animal research is high—in dollars, delays in drug approval, and in the loss of potentially bene...

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Main Author: Gail A. Van Norman, MD
Format: Article
Language:English
Published: Elsevier 2019-11-01
Series:JACC: Basic to Translational Science
Online Access:http://www.sciencedirect.com/science/article/pii/S2452302X1930316X
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spelling doaj-adb71d2c9b25497ab7a2c48664d810472020-11-25T01:35:07ZengElsevierJACC: Basic to Translational Science2452-302X2019-11-0147845854Limitations of Animal Studies for Predicting Toxicity in Clinical TrialsGail A. Van Norman, MD0Address for correspondence: Dr. Gail A. Van Norman, Department of Anesthesiology and Pain Medicine, University of Washington, 2141 8th Avenue West, Seattle, Washington 98119.; Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WashingtonSummary: Animal testing is used in pharmaceutical and industrial research to predict human toxicity, and yet analysis suggests that animal models are poor predictors of drug safety in humans. The cost of animal research is high—in dollars, delays in drug approval, and in the loss of potentially beneficial drugs for human use. Human subjects have been harmed in the clinical testing of drugs that were deemed safe by animal studies. Increasingly, investigators are questioning the scientific merit of animal research. This review discusses issues in using animals to predict human toxicity in pharmaceutical development. Part 1 focuses on scientific concerns over the validity of animal research. Part 2 will discuss alternatives to animal research and their validation and use in production of human pharmaceuticals. Key Words: animal research, drug development, toxicity, translational researchhttp://www.sciencedirect.com/science/article/pii/S2452302X1930316X
collection DOAJ
language English
format Article
sources DOAJ
author Gail A. Van Norman, MD
spellingShingle Gail A. Van Norman, MD
Limitations of Animal Studies for Predicting Toxicity in Clinical Trials
JACC: Basic to Translational Science
author_facet Gail A. Van Norman, MD
author_sort Gail A. Van Norman, MD
title Limitations of Animal Studies for Predicting Toxicity in Clinical Trials
title_short Limitations of Animal Studies for Predicting Toxicity in Clinical Trials
title_full Limitations of Animal Studies for Predicting Toxicity in Clinical Trials
title_fullStr Limitations of Animal Studies for Predicting Toxicity in Clinical Trials
title_full_unstemmed Limitations of Animal Studies for Predicting Toxicity in Clinical Trials
title_sort limitations of animal studies for predicting toxicity in clinical trials
publisher Elsevier
series JACC: Basic to Translational Science
issn 2452-302X
publishDate 2019-11-01
description Summary: Animal testing is used in pharmaceutical and industrial research to predict human toxicity, and yet analysis suggests that animal models are poor predictors of drug safety in humans. The cost of animal research is high—in dollars, delays in drug approval, and in the loss of potentially beneficial drugs for human use. Human subjects have been harmed in the clinical testing of drugs that were deemed safe by animal studies. Increasingly, investigators are questioning the scientific merit of animal research. This review discusses issues in using animals to predict human toxicity in pharmaceutical development. Part 1 focuses on scientific concerns over the validity of animal research. Part 2 will discuss alternatives to animal research and their validation and use in production of human pharmaceuticals. Key Words: animal research, drug development, toxicity, translational research
url http://www.sciencedirect.com/science/article/pii/S2452302X1930316X
work_keys_str_mv AT gailavannormanmd limitationsofanimalstudiesforpredictingtoxicityinclinicaltrials
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