Addressing drug development questions with physiologically based pharmacokinetics
Malcolm Rowland, PhD, Professor Emeritus, University of Manchester
Historically, pharmacokinetics has been descriptive and limited in its informativeness. Physiologically based pharmacokinetics (PBPK) and associated models offer a mechanistic, highly informative approach to the subject. The principles behind PBPK will be described and PBPK applications will be illustrated within the context of drug development, both in preclinical predictions of human PK and in clinical development, and within the context of addressing regulatory questions