01696nas a2200277   4500000000100000000000100001008004100002260001200043653004300055653002500098653003500123653003500158653003500193653003500228653002000263653002100283653001300304653002700317100002300344245012200367856008300489300001200572490000600584520081400590022001401404       2019                            d  c2019-1110aFDA, U.S. Food and Drug Administration10aLR, likelihood ratio10aNLR, negative likelihood ratio10aNPV, negative predictive value10aPLR, positive likelihood ratio10aPPV, positive predictive value10aanimal research10aDrug development10atoxicity10atranslational research1 aGail A. Van Norman00aLimitations of Animal Studies for Predicting Toxicity in Clinical Trials: Is it Time to Rethink Our Current Approach?  uhttps://www.sciencedirect.com/science/article/pii/S2452302X1930316X?via%3Dihub  a845-8540 v43 aAnimal 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.  a2452-302X