Bioequivalence and Bioavailability Forum

Dear Amatewadi and Gunasakaran,

In a way I think you both are right...

It is true that there will be very little published information on adverse events that can be expected after a single dose. Anyway what was observed in Phase I trials with the originator will only be the most frequent AEs (there was a limited number of subjects treated). If one adverse event described during long-term treatment was not seen in Phase I trials, it does not mean that it cannot happen after a single dose: it may be that there were not enough subjects treated to get a chance to see it. So you have to take into consideration all AEs described with the product.

On the other hand the section on risks in the ICF needs to remain readable for the subjects. First, this implies to use simple words (no subject will know what Stevens-Johnson Syndrome is, for instance). And all information in the Investigator's Brochure may not need to be carried forward into the ICF.

One possible solution is to refer to the package insert / product leaflet / whatever name you give to that sheet of paper intended for the patient which you will find inside the box of the originator product, and put in the ICF the AEs described in that document.

Regards
Ohlbe