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


❝ 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.


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