The application of population pharmacokinetics to the drug development process

Population pharmacokinetics is playing an increasing role in clinical drug development. An overview of the population approach, including software and the advantages and limitations of the approach compared to the traditional approach to pharmacokinetic studies, is given. This paper also documents h ow the area has evolved over the past 15 years and addresses some of the is sues that have arisen over the design and conduct of population studies. Fi nally, some alternative applications of the population approach are given f or areas other than clinical drug development.