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RegisterSelection of dose in BE study of Ivermectin 3 mg tabs for EU [Design Issues]
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
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
Complete thread:
- Selection of dose in BE study of Ivermectin 3 mg tabs for EUDeep patel 2016-06-03 13:34
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Strength (EMA) vs. dose (FDA) Helmut 2016-06-03 15:09
- Strength (EMA) vs. dose (FDA) Deep patel 2016-06-04 13:18
- Strength (EMA) vs. dose (FDA) Helmut 2016-06-03 15:09
Ing. Helmut Schütz