Bioequivalence and Bioavailability Forum

❝ At time of clinical conduct of your study Guideline CPMP/QWP/EWP/1401/98 with the respective Q&A document EMEA/CHMP/EWP/40326/2006 was effective.

I was going to say something about that, but we've been told on more than a few occasions in other procedures that no matter when the study was conducted it has to abide by the new guideline (ie. there is no grandfather clause). If I can't come up with anything new, I'll definitely throw in this justification re: old note for guidance.

I was also considering that fat is needed for the absorption of isotretinoin, so providing a justification that a high-fat meal may actually lessen the variability and that anything south of high-fat is actually more meaningful in distinguishing formulation effects is another avenue to pursue, I think.

Thank you, Dr Dan, and if you think of anything else, let me know.

Cheers,
Torn