Bioequivalence and Bioavailability Forum

Dear ioanam!

❝ in the Note for Guidance on the investigation of BA/BE a wider acceptance

❝ criteria for Cmax is the interval 75 - 133% that must be "prospectively

❝ defined and justified addressing in particular any safety or efficacy

❝ concerns for patients".

OK, I guess you are referring to the European Note for Guidance on BA/BE (many other countries adopted the same procedure with almost identical wording).

❝ Does this recommendation concern BE studies conducted in patients or is

❝ also available for studies conducted in healthy subjects?

For all studies (BE in healthy subjects is an accepted surrogate for clinical equivalence; the document refers to the acceptance range of a PK parameter in a study).

❝ Would you like to explain this note? I would like to have an idea for this

❝ justification.

First of all, you should have a closer look at EMEA's Questions & Answers Document (which came into operation with July 2006).
See paragraph 2 for further explanations.