Bioequivalence and Bioavailability Forum • Confirm a reference drug is highly variable

Confirm a reference drug is highly variable [Design Issues]

posted by wxp – China, 2013-03-25 15:24 (4838 d 06:34 ago) – Posting: # 10274
Views: 4,897

❝ The regulatory agencies are not interested in showing HV for the Test formulation. The only thing you have to show is that the Reference variability has CV > 30%.

Thank you, d_labes.

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]

—
Best regards,

Xipei
China

Complete thread:

How to confirm a drug is a highly variable drug? wxp 2013-03-21 15:38
- How to confirm a drug is a highly variable drug? ElMaestro 2013-03-21 16:07
  - How to confirm a drug is a highly variable drug? wxp 2013-03-22 01:58
    - How to confirm a drug is a highly variable drug? ElMaestro 2013-03-22 10:33
      - Confirm a reference drug is highly variable d_labes 2013-03-23 15:37
        
        Confirm a reference drug is highly variablewxp 2013-03-25 14:24
  - HVD ≠ HVDP Helmut 2013-03-23 17:35
    - HVD ≠ HVDP wxp 2013-03-25 14:20