Bioequivalence and Bioavailability Forum

Hi guys,

I am an MSc Biostatistics student with UTHealth, Houston. For my thesis, I want to conduct several statistical analysis on some pharmacokinetic parameters like AUCt, AUCinf, Cmax. What I need are individual concentration-time tables for de-identified participants.

My aim is to study the variability of the point estimates of the different PK parameters and their MSEs using different NCA quantification models. I don't know where to get such data. I was told the fda will not grant my request if I ask them. I also don't mind if the data is simulated.

Please any assistance will be invaluable.

Regards,
Obinoscopy