The generation and utilisation of pharmacogenetic information in various stages of
the drug development process will be presented. In the pre-clinical phase, the perspective
of data collection is early discharge of candidate compounds with possible safety
problems. In the clinical phases, pharmacogenetic data may contribute to the identification
of patient subgroups at risk of tolerability problems as well as supporting drug labelling.
The presentation will focus on how information on genetically polymorph enzymes contributes
to decision making from early stage in vitro enzyme identification to late stage population pharmacokinetic modelling.
Examples will be given to illustrate how issues like genotype-phenotype correlation,
the anticipated therapeutic index of the compound and the project objective are considered
in the interpretation of pharmacogenetic data.
