Bioequivalence and Bioavailability Forum • Scaling approach in steady state

Scaling approach in steady state [Design Issues]

posted by Helmut – Vienna, Austria, 2013-01-10 14:30 (4916 d 14:37 ago) – Posting: # 9814
Views: 3,637

Dear AB,

❝ Can we adopt a ref scaling approach in a steady state design for highly variable drugs?

Why not?

❝ if yes, in such cases what are the parameters to consider for the scaling for USFDA & EMA submission studies.

Not sure what you mean by “parameters to consider for the scaling”.

PK metrics in steady state are AUC_τ and C_max,ss.
FDA: RSABE acceptable for AUC and/or C_max if s_WR ≥0.294.
GMR within 0.8–1.25. Minimum sample size 24 (rumor!).
EMA: ABEL acceptable only for C_max if CV_WR >30%; maximum scaling factor limited to 50%.
GMR within 0.8–1.25. Clinical justification required.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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Science Quotes

Scaling approach in steady state AB 2013-01-10 08:42
- Scaling approach in steady stateHelmut 2013-01-10 13:30
  - Scaling approach in steady state AB 2013-01-11 13:42
    - Only AUCt and Cmin Helmut 2013-01-11 14:11