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

posted by lakshmiprasad - India, 2018-04-14 12:55  - Posting: # 18681
Views: 1,302

(edited by Ohlbe on 2018-04-16 10:31)

Dear All,

Good Evening,

Here I gone through the all Guidelines, I understood Now because NTI nature (https://www.fda.gov/downloads/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/abbreviatednewdrugapplicationandagenerics/ucm292676.pdf), We are going to do the Fully replicate.

Thank you very much for your guidence.


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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