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Back to the forum  Query: 2018-04-25 02:43 CEST (UTC+2h)
 

Levothyroxine Sample size and study design [Power / Sample Size]

posted by balakotu - India, 2018-04-13 07:15  - Posting: # 18676
Views: 432

(edited by Ohlbe on 2018-04-13 10:21)

Dear Prasag,
Levothyroxine is tricky product and FDA categorized it as NTI drug. As per the FDA guidance for Levothyroxine (as per Warfarin guidance), bioequivalence to be established as per reference scaled average bioequivalence (95% upper CI) and average bioequivalence (90% CI within 80-125).
Also need to show the upper limit of the 90% confidence interval for σWT/σWR is less than or equal to 2.5.
As per my understanding "σWT" will be more and it is difficult to show the 90% confidence interval for σWT/σWR. (which should be less than or equal to 2.5)
The proposed sample size may be due to "90% confidence interval for σWT/σWR" and not because of RSABE or ABE.
Considering all the above information also 48 to 52 subjects are sufficient to establish bioequivalence for Levothyroxine sodium tablets 0.3 mg (dose is 0.6 mg)


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

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