Pharmacometrics In Drug Development

increasingly popular technique for reviewing the results of clinical trials in drug development is pharmacometrics modelling. This chapter focuses on pharmacometrics' theoretical and applied elements. It begins by outlining the fundamental elements of pharmacometrics. The reasoning for the pharmacometrics analysis is then thoroughly reviewed. This includes developing the engineering-based dynamic processes that define the system under consideration, which are obtained by translating biological processes into a mathematical framework; using nonlinear mixed-effect modelling as the statistical modelling approach to define the distribution of the model parameters (pharmacokinetics (PK)/pharmacodynamics (PD)); formulating the model; and using optimization techniques, such as the Monte Carlo expectation maximisation algorithm.