11: Nonclinical Safety Assessment in Drug Development

Nonclinical Safety Assessment in Drug Development provides a fundamental coverage of what issues must be addressed (as well as means and timing of doing so) to advance a small molecule from discovery to marketplace approval – not only are the commonly considered issues of studies called out by ICH M3(R4), but also the more obscure but critical points of excipients, formulations, impurities, and route-specific local tissue tolerance all integrated into the process. The entire text is current as to early 2017 requirements and industry practices.