Bioequivalence and Bioavailability Forum • Scaling/Widening of AUC

Scaling/Widening of AUC [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2021-02-24 15:29 (209 d 20:17 ago) – Posting: # 22229
Views: 1,356

Hi Researcher101,

» I'm asking if there is any guidance allowing scaling of AUC in case of highly variable drugs and what is the range of scaling if applicable

The FDA and China accept reference-scaling for any PK-metric (see this post).
Health Canada accepts ABEL for AUC.
The WHO accepts ABEL for AUC if the study is performed in a full replicate design and variabilities of products are compared. Duno how that should be done.
In jurisdictions applying ABEL (Australia, ASEAN states, Chile, Brazil, the East African Community, Egypt, EMA, the Eurasian Economic Union, New Zealand) it is not acceptable.
However, at least for the EMA, ABEL for partial AUCs is acceptable.
Members of the Gulf Cooperation Council do not accept widening the limits for AUC.

Appetizer. Maybe useful articles about ABEL, RSABE, and a comparison.

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Helmut Schütz

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Complete thread:

Scaling/Widening of AUC Researcher101 2021-02-23 20:40 [Regulatives / Guidelines]
- Scaling/Widening of AUC Loky do 2021-02-24 13:13
  - RSABE… Helmut 2021-02-24 14:46
    - RSABE… Loky do 2021-02-24 15:30
      - RSABE… Helmut 2021-02-24 15:47
- Scaling/Widening of AUCHelmut 2021-02-24 15:29
  - Scaling/Widening of AUC Loky do 2021-02-24 16:13
  - Scaling/Widening of AUC dshah 2021-03-16 06:39
    - Scaling/Widening of AUC Helmut 2021-03-16 13:55