Bioequivalence and Bioavailability Forum • multiple dosage study

multiple dosage study [Regulatives / Guidelines]

posted by VStus – Poland, 2016-08-25 20:34 (3591 d 15:09 ago) – Posting: # 16576
Views: 7,613

Hi, Manesh!

❝ 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
- 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
        
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