Bioequivalence and Bioavailability Forum

Rabeprazole a HVD [Design Issues]

posted by Srinetram – India, 2010-07-26 12:46 (5818 d 02:24 ago) – Posting: # 5673
Views: 11,588

Dear HS, Nirali and others

❝ ❝ Is Rabeprazole Highly Variable Drug (HVD)?

❝ ❝ Inter-Subject variability is more than 50%?

Most likely Yes.

In a (pilot) BE study with RABE in 18 volunteers the figures were:
for AUC
CVintra ~ 38%
CVinter ~ 58%

for Cmax
CVintra ~ 67%
CVinter ~ 76%

software used: Winnonlin


Besides, we have tried one partial replicate too and the CVintra ~ 42% for reference.

So yes!!!
It is most likely a HVD.

Besides when we compared the Cmax values from different studies, it varied from 300-1000 ng/ml (mean values)

It looks like HVD!!!!!!

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Edit: Subject line changed to reflect content of post. [Helmut]

Complete thread:

• Sample size for Rabeprazole BE study Nirali 2007-11-22 08:10 
  • Rabeprazole not a HVD Helmut 2007-11-23 17:27
    • Rabeprazole a HVDSrinetram 2010-07-26 10:46
  • Sample size for Rabeprazole BE study MGR 2007-11-26 06:47
    • Sample size for Rabeprazole BE study Dr Andrew Leary 2010-07-23 14:50
      • Sample size for Rabeprazole BE study Helmut 2010-07-24 14:05
      • Sample size for Rabeprazole BE study Pavidus 2010-07-26 08:06
        • Sample size for Rabeprazole BE study Dr Andrew Leary 2010-07-26 09:41
          • Latin Helmut 2010-07-26 12:47
            • Latin Dr Andrew Leary 2010-07-26 13:05
              • Latin Helmut 2010-07-26 13:26
              • Latin Pavidus 2010-07-26 15:41