Bioequivalence and Bioavailability Forum • Ratio 125%: reformulate

Ratio 125%: reformulate [RSABE / ABEL]

posted by drsinghs – India, 2012-05-10 07:49 (4753 d 07:01 ago) – Posting: # 8549
Views: 7,651

❝ If your observed T/R ratio is 125 %, your chances to get a 90 % CI within 80.00 - 125.00 % in the next study, even with a replicate design, are close to nil.

Thanks ohlbe,

Can I once again request you to please comment on my other query as below?

This is regarding a Modified release HVDP. If I check same batch of test and reference by both 2 way crossover and replicate design, what kind of differences in results can I expect? Basically I want to understand the impact of change in study design on BE results.

Thanks & regards,
drsinghs

Complete thread:

Full replicate design PTM139 2012-05-03 06:01
- Full replicate design Dr_Dan 2012-05-03 15:14
  - Full replicate design PTM139 2012-05-03 16:35
    - HVDs/HVDPs: tricky business! Helmut 2012-05-03 16:58
      - HVDs/HVDPs: tricky business! PTM139 2012-05-05 07:16
      - HVDs/HVDPs: tricky business! drsinghs 2012-05-09 12:33
        
        Ratio 125% Helmut 2012-05-09 13:05
        
        Ratio 125% drsinghs 2012-05-09 13:41
        
        Ratio 125%: reformulate Ohlbe 2012-05-09 16:40
        
        Ratio 125%: reformulatedrsinghs 2012-05-10 05:49
        
        HVDs/HVDPs: tricky business! ElMaestro 2012-05-09 15:00
        
        HVDs/HVDPs: tricky business! drsinghs 2012-05-10 05:43