Statistical Techniques in Pharmaceutical Product Development

Abstract This chapter introduces the researchers to the basic concept of biostatistics and describes the objective and significance of statistical analysis. It also deliberates the statistical procedures involved in Nonclinical Trials and Clinical Trials including the Taguchi methodology. Some traditional statistical methods are also briefly covered here to demonstrate how biostatistics is used in many aspects of pharmaceutical product development. The Food and Drug Administration (FDA) perspective involving measurement system analysis, control charting, capability, acceptance sampling, and stability analysis along with the ICH Guidelines are presented here under the regulatory considerations for statistical analysis. Emphasis is given to areas where a biostatistician’s contribution will be crucial for following the Critical Path initiative of the FDA and collective effort by the pharmaceutical industry in maintaining highest level of quality and innovation. The factors responsible for a high rate of Phase III failure and the role of statistics in quality improvement of pharmaceuticals are also discussed vividly. This chapter is presented clearly to help the researchers in synthesizing the key concepts of the statistical techniques practiced in pharmaceutical product development with ease and to apply the newly acquired knowledge in their professional practice with ample confidence.