Jean-Louis Steimer, Marie-Eve Ebelin
Pharmacometrics Group, Drug Safety, Sandoz Pharma CH - 4002 Basel
Currently, there is increasing focus on integration of pharmacokinetic/pharmacodynamic (PK/PD) studies and modeling into drug development. Strategies involving specifically nonlinear mixed-effects modeling have been shown to be fruitful for investigating dose-(concentration)-effect relationships. How can such pharmacometric approaches be implemented within the framework of studies that are currently performed along the phases of clinical drug development? Some suggestions will be made, insofar they can be supported by both theoretical considerations and practical examples. The use of population concepts regarding study design (e.g. sparse blood sampling) and PK/PD data analysis will be illustrated. The value of population and individual parameters in clinical research, as well as measures of patient exposure to drug, will be briefly discussed from both personal experience and literature results.
Reference: PAGE 3 () Abstr 878 [www.page-meeting.org/?abstract=878]
Poster: oral presentation