David Giltinan
Genentech Inc; San Francisco; CA 94080-4990; USA
Following the groundbreaking work of Sheiner and co-workers, the last two decades have seen a growing recognition of the importance of accurate characterisation of inter-subject variability in the pharmacokinetic and pharmacodynamic behaviour of a drug to facilitate sensible dosing recommendations. Published work on the use of population modelling to address this issue has tended to emphasise population pharmacokinetic modelling, with relatively less attention given to the use of population pharmacodynamic models in practice.
This presentation centers on a case-study investigating dose-ranging for a potentially new cardiovascular agent. The utility of both population pharmacokinetic and population pharmacodynamic modelling to investigate inter-subject variation in PK/PD behaviour will be illustrated. Greater emphasis will be placed on the pharmacodynamic modelling efforts. In particular, aspects of the data collection and analysis with the potential to complicate pharmacodynamic model fitting will be identified.
Implications will be discussed, both for the specific case study, and for clinical drug development in general.
Reference: PAGE 9 () Abstr 82 [www.page-meeting.org/?abstract=82]
Poster: oral presentation