bioequivalence criterion for Levothyroxine [Regulatives / Guidelines]

posted by balakotu – India, 2012-07-31 15:57 (5079 d 15:49 ago) – Posting: # 9005
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Dear All,

Please clarify for Levothyroxine tablets 300 mcg for USA submission. What is the bioequivalence criterion?

Whether we have to conclude the bioequivalence
Based on 90% Confidence intervals of Uncorrected data of Levothyroxine (Total T4).

Or

Based on 90% Confidence intervals of Corrected data of Levothyroxine (Total T4).

Regards
Kotu

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