Bioequivalence and Bioavailability Forum

Dear All,

As per FDA's Bioequivalence recommendations for Ivermectin 3mg tablets, they recommended to conduct single dose, two-way crossover fasting study with 2 x 3 mg tablet (6 mg dose).

http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm296901.pdf

We are planning to conduct bioequivalence study for Ivermectin 3mg tablets for EU. The product administration posology ranges from 1 tablets to 8 tablets depending upon body weight. Link to SmPC of one of the available generic product is given below for ready reference.

http://db.cbg-meb.nl/IB-teksten/h117488_fsuk.pdf

Please suggest which dose to be used in BE study for EU market (1 tablet of 3 mg or 2 tablets of 3 mg or any other dose).

Thanks.

Kind regards