ABSTRACT
One of the critical objectives of clinical pharmacology is to individualize the dosing recommendations by estimating the population characteristics, for instance the central tendency and the variability, of the fundamental pharmacokinetics (PK) and pharmacodynamic (PD) parameters in the target population. Individualization of dosage includes describing the variability in the PK and PD parameters using covariates such as body weight, age, gender, disease state, concomitant medication(s), etc. In addition, the regulatory agencies and the pharmaceutical drug sponsors use population PK/PD analyses for a variety of other purposes through the drug development process. These include drug candidate selection, dose selection, clinical trial design, gaining insights into clinical trial outcomes and others.
