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. 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.THIS DATASET IS ARCHIVED AT DANS/EASY, BUT NOT ACCESSIBLE HERE. TO VIEW A LIST OF FILES AND ACCESS THE FILES IN THIS DATASET CLICK ON THE DOI-LINK ABOV