balakotu
★    

India,
2012-07-31 15:57
(5081 d 04:46 ago)

Posting: # 9005
Views: 2,953
 

 bioequivalence criterion for Levothyroxine [Regulatives / Guidelines]

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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
 
patilatu
☆    

2012-08-06 09:59
(5075 d 10:44 ago)

@ balakotu
Posting: # 9042
Views: 2,401
 

 bioequivalence criterion for Levothyroxine

Post reply
Dear Kotu,

Please go to the below link for the Guidance for Industry for Levothyroxine.

I hope this will help.

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071946.pdf

Regards

Patilatu

Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]
 
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