Bioequivalence and Bioavailability Forum • multiple dosage study

multiple dosage study [Regulatives / Guidelines]

posted by Mahesh M – India, 2016-08-25 11:36 (2800 d 05:52 ago) – Posting: # 16573
Views: 5,880

Hi VStus,

Thank you so much for your response.

Can we use partial AUC (labeled dose interval) from both fasting and fed two way study instead of AUC(0-tau)?

Please find below link for recently published PAR of metformin.

http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con713246.pdf

In this PAR Applicant performed three BE study on 500 mg strength:
Fasting 500 mg two way
Fed 500 mg two way
Multiple 500 mg fed
Applicant failed to demonstrate BE on multiple dose fed BE study but got approval on the basis of evidence of “lack of accumulation and the provide partial AUC for both fasting and fed two way study as supportive.

Regards

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 studyMahesh M 2016-08-25 09:36
    - multiple dosage study VStus 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