Pharmacometrics: a quantitative tool of pharmacological research

Pharmacometrics is an interdisciplinary science with tremendous potential to influence decision making through the construction of mathematical and statistical models combined with graphical methods that define, challenge, and resolve queries surrounding the biological processes of a drug. In 2004, FDA published the white paper the Challenge and Opportunity on the Critical Path to New Products, which advocates the model-based drug development (MBDD). Since then, pharmacometric analysis has become an increasingly important component of New Drug Application (NDA) and Biological License Application (BLA) submitted to FDA for drug approval, labeling and trial design decisions^1,2. The academic clinical researchers are likewise confronted with the need to use data from various sources (experimental biology, preclinical models of disease, etc) in order to organize translational clinical studies in a therapeutic area. The administrators are faced with bringing together a variety of data (preclinical and clinical data, literatures, and other regulatory submissions of similar therapies) in order to make regulatory decisions. A great deal has been published in the literatures on quantitative research, especially in the field of clinical pharmacology. Therefore, wherever in industry, academia, or regulatory agencies, pharmacometrics is at the center of the translational medicine paradigm^3,4. It is difficult to imagine a more efficient, powerful, and informative drug development and evaluation process without comprehensive pharmacometric studies.