Bioequivalence and Bioavailability Forum • Highly variable drug product

Highly variable drug product [PK / PD]

posted by jag009 – NJ, 2013-02-06 16:14 (4535 d 12:52 ago) – Posting: # 9978
Views: 8,664

Hi drgunasakaran1,

❝ In my experience, I encountered 1 out 10 products showed higher Intrasubject CV for test formulation when compared to ISCV of reference formulation.

1 out of 10? Are you referring to highly variable drug category (where ISCV is > 30%) or you mean in general (as in pooling both non-highly variable and highly variable drug)?

Thanks
John

Complete thread:

Highly variable drug product jag009 2013-02-05 22:03
- Highly variable drug product drgunasakaran1 2013-02-06 08:31
  - Highly variable drug productjag009 2013-02-06 15:14
- Highly variable drug product Dr_Dan 2013-02-06 12:10
  - Highly variable drug product jag009 2013-02-06 15:26
- Highly variable drug product luvblooms 2013-02-06 12:27
  - Highly variable drug product jag009 2013-02-06 15:28
    - Highly variable drug product Dr_Dan 2013-02-07 11:00
      - HVD ≠ HVDP Helmut 2013-02-07 13:22
      - Highly variable drug product jag009 2013-02-07 15:22