The inability to establish safety and/or efficacy of the drugs has always been the chief source for clinical trial failures and it is disappointing that even if a drug successfully enters the pharmaceutical market, there still exist a striking number of non-responders/toxic responders due to the underlying differences between the population characteristics and the study cohort. This evidently reveals that a substantial amount of information about the drug is left unexplored and there is a scope for improvement when these insights are gained. On this basis, Pharmacometrics is emerging as an effective tool that uses mathematical models to elucidate the interactions between drugs, diseases, and patients and is increasingly being applied in the pharmaceutical industries, regulatory agencies, academic researches, and patient-care to enhance the decision-making. This review highlights the applications and benefits of pharmacometrics throughout the life-cycle of a drug, from the development stage to the applied pharmacotherapy at the bedside with selected examples.
Key words: pharmacometrics; quantitative clinical pharmacology; modelling and simulation; drug development; dosage optimisation
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