Virtual Bioequivalence: a myth or coming reality? [Dissolution / BCS / IVIVC]

posted by Helmut Homepage – Vienna, Austria, 2021-12-23 22:31 (153 d 19:21 ago) – Posting: # 22714
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Hi Mittyri,

sorry for excavating such an old post.

» AFAIK regulatories are also interested and funding some of them.

See here and the back-story by authors of the FDA.*

» What do you think?

In my CRO I had the displeasure to deal with topical diclofenac. Low plasma concentrations doable by GC/MS with stable isotope IS but extremely variable. Really ugly profiles. Synovia was as close to a nightmare you can get. How to sample without contamination? We tried a lot of crazy stuff (cleaning the skin with acetone and isopropanol, skin stripping, …). Nothing worked. We ended up in patients scheduled for a total knee arthroplasty. Recruitment not easy “Why should I apply the cream daily under occlusion for three weeks when my knee is cut off anyway?” Turned out that >50% had a so-called ‘dry knee’, i.e., no synovia at all. Bad luck.
Given all that, I’m asking myself on which data the FDA’s model is based upon and how reliable they are. :confused:



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