Bioequivalence and Bioavailability Forum • Acceptable difference (BE history)

Acceptable difference (BE history) [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2015-07-03 16:49 (3509 d 10:19 ago) – Posting: # 15035
Views: 8,762

Dear Detlew,

❝ ❝ critical dose drugs 90.0–112.0%).

❝

❝ Although this is a bit of generous rounding to one decimal :cool:

I told Eric Ormsby at the last BioInternational conference (London, October 2008) that on the long run the mean of generic NTIDs will be \(\sqrt{0.900 \times 1.120} = 1.003992 \ldots\). IIRC he replied “We can stand that. 112% is just easier to remember.”…
When discussions were hot in the mid-1980s (switching from untransformed to log-transformed data) we had a width of the acceptance range of 0.40 (80–120%) based on an acceptable Δ of 0.20:

Some people proposed θ₁ = 1–Δ (0.80) and θ₂ = 1/θ₁ (1.25) or ±ln(0.80).
Others argued that with this method the AR in the original scale (0.45) will be wider than the previous standard (0.40). They suggested an even more conservative approach:
θ₂ = 1+Δ (1.20) and θ₁ = 1/θ₁ (0.83) or ±ln(0.83).
A minority suggested to modify Δ in such a way (to 0.1802…) that the AR keeps the previous width, i.e., to θ₁ 0.8198 and θ₂ 1.2198.

We all know which party won – leading to limits “which are easy to remember”. Yes, this was at the end the unbeatable argument. :-D

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

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Complete thread:

HC Proposed Policy on Bioequivalence Standards for HVDS balakotu 2015-07-02 09:05 [Regulatives / Guidelines]
- HC Proposed Policy on Bioequivalence Standards for HVDS d_labes 2015-07-02 09:19
- Bloody partial replicate again Helmut 2015-07-02 13:20
  - Bloody partial replicate again Lucas 2015-07-02 13:35
    - Which model? Helmut 2015-07-02 16:41
      - Which model? Lucas 2015-07-02 18:06
- HC Proposed Policy on Bioequivalence Standards for HVDS drgunasakaran1 2015-07-02 17:08
  - AUC and Cmax Helmut 2015-07-02 17:37
- HC for HVDs d_labes 2015-07-03 08:21
  - HC for HVDs Helmut 2015-07-03 11:55
    - Rounding d_labes 2015-07-03 12:53
      - Acceptable difference (BE history)Helmut 2015-07-03 14:49
    - Off topic ElMaestro 2015-07-03 13:02
      - Playing around with α (not exactly brilliant) Helmut 2015-07-03 15:38
        
        Playing around with α (not exactly brilliant) ElMaestro 2015-07-03 16:35
        
        Playing around with α (not exactly brilliant) Helmut 2015-07-03 16:44
        
        OT – Philosophers on duty d_labes 2015-07-03 21:11