Description
This interactive 2-day course will provide a comprehensive and detailed programme describing the pharmacokinetic and metabolism studies required for regulatory submissions. The course is intended for those that have a previous background in pharmacokinetics and also for those who wish to get an in depth training in pharmacokinetics whilst not being specialists in the field.
Attendance will provide an overview on study design, conduction and interpretation including temporal placement throughout the drug development program.
Topics will include both preclinical as well as clinical studies without excessive use of mathematics. The course will provide trouble-shooting strategies for all the main studies and will focus on the critical aspect for a smooth completion of the pharmacokinetic and metabolism registration package.