Bioequivalence and Bioavailability Forum

❝ 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.