Introduction

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.

The U.S. Food and Drug Administration (FDA) utilizes population analyses as an aid in making regulatory decisions at almost all stages of the investigational new drug (IND) and new drug application (NDA) review processes. The leadership of the FDA in making the current drug development process more efficient is reflected in the many guidances that are issued for industry to date. The FDA is the first institution to set up a pharmacometrics group exclusively for the purpose of reviewing and conducting research in PK/PD modeling and simulation (M&S) related topics. The aim of this chapter is to briefly present the population analyses methods and discuss some specific applications of the same in regulatory review processes.

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