Bioequivalence and Bioavailability Forum • Bioequivalence study of Sofosbuvir

Bioequivalence study of Sofosbuvir [Regulatives / Guidelines]

posted by Dr Naghma Hashmi – Pakistan, 2016-03-18 13:34 (2953 d 08:39 ago) – Posting: # 16116
Views: 9,855

Hi

Can anyone guide me for the bio-equivalence study of Sofosbuvir? should it be conducted as per WHO Guidance Document 25 March 2015, Notes on the design of bioequivalence study: Sofosbuvir

I have few queries regarding this document

Bioequivalence will be plan in fed state or fasting?
My recommendation is of fasting as according to
Effect of Food (Prescribing information)
Relative to fasting conditions, the administration of a single dose of SOVALDI with a standardized high fat meal did not substantially affect the sofosbuvir Cmax or AUC0-inf. The exposure of GS-331007 was not altered in the presence of a high-fat meal. Therefore, SOVALDI can be administered without regard to food.
should the sofosbuvir metabolite also analyzed?
What will be the minimum sample size?

Thanks

Dr. Hashmi
Technical Coordinator

Complete thread:

Bioequivalence study of SofosbuvirDr Naghma Hashmi 2016-03-18 12:34 [Regulatives / Guidelines]
- Which “target regulation”? Helmut 2016-03-18 14:23
  - Bioequivalence study of Sofosbuvir Dr Naghma Hashmi 2016-03-19 10:59
    - No “WHO regulation”! Helmut 2016-03-19 18:03
      - No “WHO regulation”! Dr Naghma Hashmi 2016-03-22 04:51
        
        Science ≠ truth ∧ regulations ≠ science Helmut 2016-03-22 14:06
  - Which “target regulation”? nobody 2016-04-27 09:15