Bioequivalence and Bioavailability Forum

Hi Anand,

❝ Request to provide Highly variable Drugs Bio-Equivalence criteria for canada?

❝

❝ For Cmax Ratio 80.00% - 125.00%

I don’t understand your question. What you state here is supported by the current guidance, Section 2.1.1.8:

For the purpose of bioequivalence testing, there is no compelling need for a distinct category of “highly variable” drugs, given that there is sufficient permitted flexibility in study design to address exceptional cases. […] This type of flexibility in study design does not require the application of special bioequivalence standards.

We may see an update sooner or later. Different approaches were discussed in the June 2014 meeting of the “Scientific Advisory Committee on Pharmaceutical Sciences and Clinical Pharmacology”. I guess (!) Health Canada will essentially follow FDA’s RSABA. Let’s see.