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

posted by Pandu - India, 2017-10-23 04:23  - Posting: # 17904
Views: 327

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.

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