Bioequivalence and Bioavailability Forum • How to confirm a drug is a highly variable drug?

How to confirm a drug is a highly variable drug? [Design Issues]

posted by wxp – China, 2013-03-22 02:58 (4849 d 02:26 ago) – Posting: # 10258
Views: 5,064
(edited on 2013-03-22 10:17)

Hi ElMaestro,

I agree with the way you mentioned. But it is time-consuming and needs more money.We did a 2×2 bioequivalance study of simvastin in 24 healthy volunteers. The intra-CV was >30%, which demonstrated that the sample size was not enough for a HV drug. I think if we can confirm a drug a HV drug before the study design, it will save a lot of time and money.

Best regards,

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! [Ohlbe]

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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 variable wxp 2013-03-25 14:24
  - HVD ≠ HVDP Helmut 2013-03-23 17:35
    - HVD ≠ HVDP wxp 2013-03-25 14:20