Bioequivalence and Bioavailability Forum • HVDs/HVDPs: tricky business!

HVDs/HVDPs: tricky business! [RSABE / ABEL]

posted by drsinghs – India, 2012-05-10 07:43 (4753 d 06:37 ago) – Posting: # 8548
Views: 7,689

❝ Big risk.

❝

❝ If the CV for AUC is bigger than CV for Cmax then there is a risk the study will be flagged for inspection by some authorities, especially FDA. It is often a sign of something having gone badly wrong, and is generally not lending the data much credibility.

Dear ElMaestro,
My formulation is Modified release do you still feel it will be flagged for inspection just because CV for AUC is bigger than CV for Cmax.

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%: reformulate drsinghs 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