Bioequivalence and Bioavailability Forum • Scaled Average Bioequivalence

Scaled Average Bioequivalence [Regulatives / Guidelines]

posted by graveendranath – 2010-01-06 08:36 (6012 d 17:15 ago) – Posting: # 4563
Views: 7,594

Dear Helmut,

We want to conduct a study with partial replicated design (Reference twice) for Europe regulatory. My doubt is

1. Does the Europe Regulatory accepts the Scaled Average Bioequivalence method for highly variable drugs?
2. If we can show that the Intra cv for reference product is > 30% then can we use wider limits (75-133)?

Thank You

—
Rgds
Raveendranath

Complete thread:

Scaled Average Bioequivalencegraveendranath 2010-01-06 07:36 [Regulatives / Guidelines]
- RSABE (EU) Helmut 2010-01-06 17:01
  - RSABE (EU) d_labes 2010-01-07 09:14
    - RSABE (EU) Helmut 2010-01-07 13:21
      - Sample size partial replicate design d_labes 2010-01-07 13:56
        
        Sample size partial replicate design Helmut 2010-01-07 14:23
        
        Sample size partial replicate design: df d_labes 2010-01-07 16:21
        Sample size partial replicate design: variance d_labes 2010-01-08 10:37