Bioequivalence and Bioavailability Forum 21:51 CEST

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

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

posted by lakshmiprasad - India, 2018-04-14 12:55  - Posting: # 18681
Views: 1,042

(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]

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
18,782 posts in 4,002 threads, 1,256 registered users;
online 15 (0 registered, 15 guests [including 11 identified bots]).

[…] our greatest mistake would be to forget that data
is used for serious decisions in the very real world,
and bad information causes suffering and death.    Ben Goldacre

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5 RSS Feed