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

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

posted by drsinghs – India, 2012-05-09 14:33 (5146 d 12:48 ago) – Posting: # 8542
Views: 10,031

Dear HS and Dr. Dan,

My query is similar to the ongoing discussion.

Below situation may not be practically feasible but still I am asking this to gain some knowledge. Irrespective of regulatory requirements, cost and other issues; I request valuable opinion from both of you on following.

This is regarding a 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?

To be more precise I will share a hypothetical case - if 2 waycrossver study is already completed and observed T/R ratio is 115 for Cmax and 125 for AUCt with > 30% intraCV for Cmax and > 45% for AUCt, Can I expect successful results if I go for replicate design?

Thanks & regards,
drsinghs

Complete thread:

Full replicate design PTM139 2012-05-03 06:01 [RSABE / ABEL]
- 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