Animal Use in Carcinogenicity Studies Supporting Approved New Drug Applications in the U.S., 2015-2019

Data supports "Animal Use and Opportunities for Reduction in Carcinogenicity Studies Supporting Approved New Drug Applications in the U.S., 2015-2019" in Regulatory Toxicology and Pharmacology (in revision). Includes: number of animals used in long- and- short term carcinogenicity and pivotal chronic toxicity studies as summarized by FDA in its publicly available reviews of New Drug Applications separated by control and dose groups in main carcinogenicity, toxicokinetics and other satellite studies; justifications for waiving carcinogenicity studies; concern for human toxicity and animal study results from current Supplemental Product Labeling; tables, figures, and supporting analysis. Changes from previous version: "Discussion" sheet renamed "Abstract & Discussion" and two tables added to support calculating the combined total reduction in the revised MS abstract; animals used in extra control groups in TK and other satellite studies have been added to the total reduction resulting from using single control groups.