Why to dose 2 tablets of 200 mg tablets of Amiodarone in BE studies [Design Issues]
According to the OGD, proving bioequivalence with an oral dose of Amiodarone 200 mg is considered sufficient. But, BE studies are being done with 2 tablets of Amiodarone 200 mg. Kindly advise on this as the present bioanalytical methodologies and instruments are able to detect very low plasma concentrations of the drug.
Edit: Please follow the Forum’s Policy. [Helmut]
Edit: Please follow the Forum’s Policy. [Helmut]
Complete thread:
- Why to dose 2 tablets of 200 mg tablets of Amiodarone in BE studiesKK 2017-05-26 11:09 [Design Issues]