Bioequivalence and Bioavailability Forum • PK Stat analysis for Levothyroxine sodium studies for USFDA submission

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

posted by jag009 – NJ, 2017-10-24 07:45 (1980 d 17:37 ago) – Posting: # 17909
Views: 2,575

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

Complete thread:

PK Stat analysis for Levothyroxine sodium studies for USFDA submission Pandu 2017-10-23 06:23 [Design Issues]
- PK Stat analysis for Levothyroxine sodium studies for USFDA submissionjag009 2017-10-24 05:45