Pharmacological modeling and biostatistical analysis of a new drug

Revathi Ananthakrishnan¹, Philimon Gona²

¹Cambridge, MA, USA; ²Boston University, Mathematics and Statistics Department, 111 Cummington St, Boston, MA-02215, USA

Abstract: Clinical research and clinical trials of experimental drugs to treat human diseases have gained greater importance in recent years. Phase I–IV clinical trials offer patients the opportunity to gain access to a new, more efficacious and safer medication to alleviate or cure their disease. There are potential side effects of every new drug; however, such trials and studies are crucial for drug development and testing in humans. The US Food and Drug Administration (FDA) regulated process of evaluating a new drug for treating a particular disease in humans is long, rigorous, and includes the stages starting from preclinical research through the entire human clinical trials process. This review synthesizes results from the above stages and describes the entire mechanism of the clinical study of a new drug for human disease. It emphasizes the associated mathematical modeling and statistical analyses, and bridges pharmacological modeling and biostatistics in clinical research and also provides a basic theoretical overview to biomedical experimentalists. The modern trend in clinical research involves a unified approach among several biomedical subspecialties and it is hoped that even more integrated studies of new drugs will continue to be carried out, leading to novel drugs that are highly effective in curing the associated condition.

Keywords: PK/PD pharmacological modeling, biostatistical analyses of clinical trials data, clinical trials, phases of clinical trials, types and designs of clinical trials