Jurisdiction? [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2020-08-27 17:32 (233 d 20:08 ago) – Posting: # 21894
Views: 1,767

[image]Hi Pharma_88,

» We are thinking to perform steady state BE study for XXX submission…

Unfortunately my crystal ball is in the laundry and reading tea leaves turned out to be an insufficient substitute. ;-)
Hence, which XXX?

» … where Test product is ER formulation and Reference product is IR formulation.


Not BE, but comparative BA. You can only hope for similar extent of absorption but never for rate of absorption in a comparison of ER vs IR. Furthermore, BE means similarity in PK metrics of interest if equimolar doses are administered. Sometimes one has to increase the ER dose to get similar AUCs… Whatever is applicable in your case, BE is the wrong term.


» Further, Its HVD product. So, question is whether is this feasible to conduct replicate BE IR vs ER and if yes…

Is it a highly variable drug 1 or are one – or both – products 2 highly variable? But, in principle, yes.

» … then what are the parameters for conclusion?

Once you tell us what XXX is, we can possibly help.

  1. HVDs exhibit highly variable clearances (CVwR ≥30% if administered as a solution).
  2. HVDPs may additionally – or solely – show highly variable absorption.

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Helmut Schütz

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