Bioequivalence and Bioavailability Forum

Dear Helmut!

Thanks for the answers. I saw earlier the guideline mentioned. I read it through quickly but I have not found what should be done in case of API changes. It refers to the changes of excipients the site of manufacture and the technological process.
This problem is not too rare, it is quite frequent that an API supplier changes the manufacturing method and it finally leads to a different API.
Not to mention changing the API supplier, which could result an absolutely different API.
I would not think that all changes in the API mean that the bioequivalence study should be repeated. But I could not find any references, guidelines which clearly declare what should be done in such cases.

Thanks again!

Best regards,
Laszlo

Edit: Full quote removed. Please see this post! [HS]