Genetic toxicology studies are an integral part of the basic toxicological information package used in the risk assessment and decision-making process for a new drug. In this short guide, we walk through four critical in vitro genotoxicity assays drug developers need...
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Reproductive Toxicology & the EPA’s Tiered Testing System
The endocrine system comprises myriad glands, hormones and receptors throughout the body that regulate biological processes from birth to death. Chief among those processes is the differentiation, growth and function of the human reproductive system. Human...
5 Critical Nonclinical Toxicology Studies Required for IND Submission
Toxicology studies are required for Investigational New Drug (IND) and New Drug Application (NDA) submissions in order to fully define the safety profile of a drug – and maintain the highest level of patient safety. In this short guide, we cover the core battery...