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Back to the forum  2018-06-20 07:24 CEST (UTC+2h)
Pandu
Regular

India,
2017-10-23 06:23

Posting: # 17904
Views: 1,217
 

 PK Stat analysis for Levothyroxine sodium studies for USFDA submission [Design Issues]

Hi,
We are conducting Levothyroxine sodium studies for USFDA submission, I required one clarity as per OGD.

OGD says that Post-dose levothyroxine measurements by the baseline levothyroxine value should be corrected in each period for each subject. The baseline value should be obtained from the average of three levothyroxine measurements taken before dosing (i.e., at 0.5 h, 0.25 h, and 0 h pre-dose.

OGD is not mentioned about exclusion of subjects from Pharmacokinetic and statistical analysis, after baseline correction if subject having more-than 5% of Cmax on pre-dose concentration. This criteria we can apply for endogenous products or not?

Awaiting for your replays.
jag009
Hero

NJ,
2017-10-24 05:45

@ Pandu
Posting: # 17909
Views: 950
 

 PK Stat analysis for Levothyroxine sodium studies for USFDA submission

Hi,

» OGD is not mentioned about exclusion of subjects from Pharmacokinetic and statistical analysis, after baseline correction if subject having more-than 5% of Cmax on pre-dose concentration. This criteria we can apply for endogenous products or not?

Why now? Theoretically speaking after baseline correction the amount of drug in the system is "ought" to be attributed to the drug products.

J
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