Pharmacometrics: Application in Drug Development and Clinical Practice

Abstract

In the last 4 years, pharmacometrics (PMX) has advanced to the point that it is now a crucial part of drug development. Drug delivery systems and molecules with more complex architecture are being developed as technology advances. Pharmacodynamic modelling is based on the quantitative integration of pharmacokinetics, pharmacological systems, and (patho-) physiological processes in order to comprehend the intensity and time course of drug effects on the body. As a result, the drug absorption and disposition processes after the administration of these drug delivery systems and engineered molecules become exceedingly complex. The research field of drug delivery focuses on the development of new techniques to manipulate drug absorption and disposition to achieve a desirable effect for the PMX model used. An opportunity to combine pharmacokinetic and pharmacodynamic model-based estimations with pharmacoeconomic models emerges given the unpredictability in the dose-concentration-effect relationship of medications. Model-based drug development (MBDD) has been found to address the underlying causes of medication failure, hence enhancing the productivity, effectiveness, and success of late-stage clinical research. The pharmacokinetic (PK) model principles in optimizing the drug dose to suit individual patient needs and achieving maximum therapeutic utility are called clinical pharmacology. Pharmacodynamics (PD) relates response to the concentration of drugs in the body. Disease progression model-based evaluation of disease progression is an important aspect of drug development and pharmacology. The future perspective of pharmacometrics in drug development and clinical practices is challenging.