Acute, Sub-Acute, Sub-Chronic and Chronic General Toxicity Testing for Preclinical Drug Development

Pharmaceutical products must undergo a battery of preclinical general toxicology studies to provide information regarding the safety of a potential new drug prior to initiation of the various clinical trials in humans, which are necessary before a molecule can become an approved drug. The order of the general toxicology studies begins with acute screening and progresses through longer durations of exposure up to as much as 1 year in length. In this chapter, numerous regional and global considerations regarding the influence rendered on the types of general toxicology study designs needed for regulatory submission will be discussed. Practical knowledge on how to integrate general toxicology assessments into the preclinical program is shared herein. By understanding the intricacies of the general toxicology plan, the hope is that it will facilitate smoother milestone transitions as the potential drug candidate moves forward in development.