Bioequivalence and Bioavailability Forum

balakotu ★ India, 2012-07-31 15:57 (5077 d 18:47 ago) Posting: # 9005 Views: 2,930	bioequivalence criterion for Levothyroxine [Regulatives / Guidelines] Post reply
	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
(5072 d 00:44 ago)

@ balakotu
Posting: # 9042
Views: 2,390

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]

bioequivalence criterion for Levothyroxine [Regulatives / Guidelines]

bioequivalence criterion for Levothyroxine