Bioequivalence and Bioavailability Forum

Dear all,

This is regarding few specific requirements for the Biostudy as per ANVISA/canadian guideline, for which i need some understanding.

The exclusion of more than 5% of the subjects from the study or the lack of over 10% of the values for blood concentration of the drug resulting from administration of each drug product will not be accepted. [Statement as per ANVISA guideline]
It is rarely acceptable to exclude more than 5 percent of the subjects or more than 10 percent of the data for a single subject-formulation combination. [Statement as per canadian guideline]

In case dropouts, due to ADR (e.g. incidence of vomiting in biostudy of drug which can cause vomiting in the study) or subject not reported in period II due to personal reason or subject not reported in ambulatory sampling, exclusion of more than 5% subject is inevitable.

Now my question is, in case of above circumstances, ANVISA/canadian regulatory is strict regarding above regulation or may accept the study after giving justification.

regards
chak