Regulatory Nonclinical Statistics

The nonclinical statistics teams in the Center of Drug Review and Research of the Food and Drug Administration (FDA) conduct regulatory reviews, statistical consultation, and statistical methodology development in nonclinical regulations. In this chapter, we provide a brief description of the two teams and provide two examples in statistical research development. In the first example, we describe the historical background and evolution of statistical methodology development in the last 20 years for the acceptance sampling and lot evaluation procedures on dose content uniformity involved with FDA Chemistry Manufacturing, and Control (CMC) Statistics Team. In the second example, we illustrate the research activities of Pharmacological/Toxicological (Pharm-Tox) Statistics Team at FDA with the background and evaluation of multiple pairwise comparisons in animal carcinogenetic studies.