multiple dosage study [Regulatives / Guidelines]
Hi, Manesh!
I can only cite same section of the Guideline once more again... Why not if there is no accumulation and partialAUCs will demonstrate BE. What if these parameters will be highly variable?
Thank you for the reference!
Regards, VStus
❝ Can we use partial AUC (labeled dose interval) from both fasting and fed two way study instead of AUC(0-tau)?
I can only cite same section of the Guideline once more again... Why not if there is no accumulation and partialAUCs will demonstrate BE. What if these parameters will be highly variable?
❝ http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con713246.pdf
Thank you for the reference!
Regards, VStus
Complete thread:
- multiple dosage study Mahesh M 2016-08-18 12:50 [Regulatives / Guidelines]
- multiple dosage study VStus 2016-08-24 21:37
- multiple dosage study Mahesh M 2016-08-25 09:36
- multiple dosage studyVStus 2016-08-25 18:34
- multiple dosage study BE-proff 2016-08-26 10:45
- τ in SD = intended dosage interval Helmut 2016-08-26 11:08
- multiple dosage study Mahesh M 2016-08-26 14:17
- Some questions from EGA regarding MR Guideline mittyri 2016-08-26 17:43
- Quod licet Iovi, non licet bovi Helmut 2016-08-26 19:42
- τ in SD = intended dosage interval Helmut 2016-08-26 11:08
- multiple dosage study Mahesh M 2016-08-25 09:36
- multiple dosage study VStus 2016-08-24 21:37