Chapter 5. Some Statistical Considerations in Nonclinical Safety Assessment

Wherly Hoffman^[]

^[] Wherly Hoffman is Head, Toxicilogy/Drug Disposition and Animal Health Statistics, Eli Lilly, USA.

Cindy Lee^[]

^[] Cindy Lee is Associate Senior Statistical Analyst, Toxicilogy Statistics, Eli Lilly, USA.

Alan Chiang^[]

^[] Alan Chiang is Senior Research Scientist, Toxicilogy Statistics, Eli Lilly, USA.

Kevin Guo^[]

^[] Kevin Guo is Assistant Senior Statistician, Toxicilogy Statistics, Eli Lilly, USA.

Daniel Ness^[]

^[] Daniel Ness is Research Advisor, Toxicilogy, Eli Lilly, USA.

Understanding the intrinsic toxicological properties of chemicals is fundamental to evaluating their safety. Such data are derived from toxicological studies that are required by national and international regulatory organizations. These data are used to determine the potential hazards and to gain an understanding of the potential risks to humans. This chapter provides a brief overview of the role of nonclinical safety assessment in drug development and covers serval important statistical considerations in defining hazards. The topics include randomization, power evaluation and data analysis. Examples are given throughout the chapter to illustrate the described statistical methods for each topic.