Why to dose 2 tab­lets of 200 mg tab­lets of Amiodarone in BE studies [Design Issues]

posted by KK – India, 2017-05-26 13:09 (2499 d 00:06 ago) – Posting: # 17420
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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.


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