Bioequivalence and Bioavailability Forum

Hi all
another interesting aspect:
"In general, a bioequivalence study should be conducted under fasting conditions as this is considered to be the most sensitive condition to detect a potential difference between formulations." (CPMP/QWP/EWP/1401/98 Rev. 1). But what to do if the drug can not be administered in the fasted state due to gastro-intestinal complications? Also in these cases the SmPC does certainly not contain any information about the composition of a meal to be taken. What should we do if the rate of absorption is reduced after giving a high-fat meal compared to fasting conditions. The Q&A document points out that: "The composition of the meal should be described and taken into account, since a light meal might sometimes be preferable to mimic clinical conditions, especially when the fed state is expected to be less sensitive to differences in pharmacokinetics." Accordingly a bioquivalence study under fed conditions with a standardized non high-fat meal should be indicated. From a scientific point of view a bioequivalence study with an administration of a standardized non high-fat meal is more sensitive to detect differences in formulations than a study with the administration of a high-fat and high-calorie meal, but this is not the point of view of the regulatory authorities, as shown on the EGA meeting held in London on June 1st.
Kind regards
Dan