Medical Statistics in Drug Development and Regulatory Approval

Abstract

In the rapidly evolving field of pharmaceuticals, the application of medical statistics has become increasingly important. This chapter provides an insightful overview of the integral role that statistical analysis plays in the journey of drug development, highlighting its impact from preclinical trials to phase III studies as well as its significance in regulatory decision-making. This chapter begins by establishing the foundational principles of statistical methods in clinical research. Specific statistical models and techniques used to ensure the safety and efficacy of new drugs have been explored. Key topics include experimental design, hypothesis testing, data interpretation, and the management of potential biases. This chapter highlights the indispensability of robust statistical practices for achieving reliable and scientifically sound results, which are critical for gaining regulatory approval. In the future, this chapter discusses emerging trends in biostatistics and their potential impact on future drug development and approval processes.