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Back to the forum  2018-06-22 19:24 CEST (UTC+2h)

subject inclusion criteria in PK and stat and BE conclusion [Regulatives / Guidelines]

posted by Ramesh Ramalingam - India, 2017-09-05 09:17  - Posting: # 17778
Views: 2,196

(edited by Ohlbe on 2017-09-05 09:59)

Dear ElMaestro,

Thank you very much for your response.

Based on your response i understand that the subject inclusion criteria for pharmacokinetic and statistical analysis as follows for NTI drugs:

SWR calculations & SWT calculations & Average BE: subject should completed all the study periods
SWR calculations & Average BE:subject who completed with Reference twice and Test once
SWT calculations & Average BE:subject who completed with Reference once and Test twice
SWR calculations:subject who completed with Reference twice
SWT calculations:subject who completed with Test twice

Based on this subject should complete at least two treatment periods of the study wright?

for HVDs(fully replicate design):

SWR calculations & Average BE: subject who completed all the study periods
SWR calculations:subject who completed with Reference twice
Average BE:Subject who complete at least one test and one reference treatment

Hence, Subject should complete at least one test and one reference treatment period or both reference treatment periods of the study, wright?

Kindly advice if anything wrong.

Regards,
Ramesh Ramalingam


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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