Bioequivalence and Bioavailability Forum 19:03 CEST

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Pandu
Regular

India,
2017-10-23 06:23

Posting: # 17904
Views: 1,475
 

 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: 1,165
 

 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
Back to the forum Activity
 Thread view
Bioequivalence and Bioavailability Forum |  Admin contact
18,700 posts in 3,984 threads, 1,241 registered users;
online 19 (0 registered, 19 guests [including 11 identified bots]).

When puzzled, it never hurts to read the primary documents –
a rather simple and self-evident principle that has, nonetheless,
completely disappeared from large sectors
of the American experience.    Stephen Jay Gould

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