Bioequivalence and Bioavailability Forum • Bioanalytical method validation -compliance-topical steroid

Bioanalytical method validation -compliance-topical steroid [Regulatives / Guidelines]

posted by Tina – India, 2014-02-25 13:39 (4507 d 22:27 ago) – Posting: # 12495
Views: 4,092

Dear all,

Is it required for Bioequivalence study of topical steroids to comply with the 'Guideline on bioanalytical method validation', (21 July 2011, EMEA/CHMP/EWP/192217/2009)?

I always thought that the specific FDA guideline covers the specific validation of the chromameters involved in a topical steroid BE study.

Look forward to advise from the forum members.

Complete thread:

Bioanalytical method validation -compliance-topical steroidTina 2014-02-25 12:39
- Bioanalytical method validation -compliance-topical steroid ElMaestro 2014-02-25 21:53
  - Bioanalytical method validation -compliance-topical steroid Tina 2014-02-26 12:23
    - Easy ElMaestro 2014-02-26 12:35
      - Easy Tina 2014-02-26 16:10
        
        Easy nobody 2014-02-27 14:18