Due to frequent clinical trial failures and consequently fewer new drug approvals, the need
for improvement in drug development has, to a certain extent, been met using model-based drug
development. Pharmacometrics is a part of pharmacology that quantifies drug behaviour,
treatment response and disease progression based on different models (pharmacokinetic – PK,
pharmacodynamic – PD, PK/PD models, etc.) and simulations. Regulatory bodies (European
Medicines Agency, Food and Drug Administration) encourage the use of modelling and
simulations to facilitate decision-making throughout all drug development phases. Moreover, the
identification of factors that contribute to variability provides a basis for dose individualisation in
routine clinical practice. This review summarises current knowledge regarding the application of
pharmacometrics in drug development and clinical practice with emphasis on the population
modelling approach.
