Jurisdiction? [Regulatives / Guidelines]

posted by Pharma_88 – India, 2020-08-31 08:26 (90 d 14:12 ago) – Posting: # 21898
Views: 1,241

» » We are thinking to perform steady state BE study for XXX submission…
»
» Hence, which XXX?

Its for EMEA.

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

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.

</nitpick>

Can you please elaborate to understand. If you can provide me any supportive literature to go in detail its really helps me.

» » 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 or are one – or both – products highly variable? But, in principle, yes.
»
» » … then what are the parameters for conclusion?
»
» Once you tell us what XXX is, we can possibly help.

EMEA

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