Bioequivalence and Bioavailability Forum • HVD ≠ HVDP

HVD ≠ HVDP [Design Issues]

posted by Helmut – Vienna, Austria, 2013-03-23 18:35 (4836 d 21:24 ago) – Posting: # 10268
Views: 5,074

Hi wxp & ElMaestro,

❝ […] Some member or other may chime in with the distinction between drug and drug product.

HVD: CV_W of a solution ≥30%.
HVDP: CV_W of a formulation ≥30%.

In both cases replicate administrations are required. My favorite example: Some gastric resistant formulations of diclofenac are HVDPs, practically all topical formulations are HVDPs – whereas diclofenac itself is not a HVD (CV_intra of a solution ~8%).

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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 ≠ HVDPHelmut 2013-03-23 17:35
    - HVD ≠ HVDP wxp 2013-03-25 14:20