Bioequivalence and Bioavailability Forum

Thank you for the info, Helmut.

❝ If required, a brief scientific rationale for the guidance will be provided.

What does that mean? If required by whom? CHMP? Themselves? People who comment?

I would hope they'd publish rationales in all cases. After all, the determination of PSGs at EMA will involve heavy discussion of each individual guidance with determination of pros and cons, challenges and solutions etc going back on forth between the members. There will be plenty of rationale behind the curtains. Plus, since guidelines are guidelines and not laws, knowing the rationale for each of the PK-workgroup's PSGs would allow applicants to better distinguish between must and should.