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RegisterPotency correction - I still don't get it [Regulatives / Guidelines]
Hi all,
section 4.1.8 of the EMA guideline opens up for potency calculation for BE evaluation.
I can see what it does. I still can't, after having read up on this for 8 years, see in which way that opportunity does anything good for the sake of the EU patient.
Can somebody give me a numerical example illustrating why potency correction is to the advantage of not only the Sponsor but also the patient??
90% CI is 77-108, but if assays differ, then we divide and multiply and do some gymnastics on the numbers, and hey presto we now have an approvable product. Nice for Sponsor (or at least the guy in the Armani suit). But is that really advantageous for the Patient? It may be if we seriously play around with the definition of average bioequivalence. Let me hear your thoughts, please: Under which assumptions in your opinion will a potency correction help regulators decide on relative rate and extent of absorption, and how does this (these) assumption(s) fit into your understanding of average BE?
Many thanks.
section 4.1.8 of the EMA guideline opens up for potency calculation for BE evaluation.
I can see what it does. I still can't, after having read up on this for 8 years, see in which way that opportunity does anything good for the sake of the EU patient.
Can somebody give me a numerical example illustrating why potency correction is to the advantage of not only the Sponsor but also the patient??
90% CI is 77-108, but if assays differ, then we divide and multiply and do some gymnastics on the numbers, and hey presto we now have an approvable product. Nice for Sponsor (or at least the guy in the Armani suit). But is that really advantageous for the Patient? It may be if we seriously play around with the definition of average bioequivalence. Let me hear your thoughts, please: Under which assumptions in your opinion will a potency correction help regulators decide on relative rate and extent of absorption, and how does this (these) assumption(s) fit into your understanding of average BE?
Many thanks.
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Potency correction - I still don't get itElMaestro 2018-06-23 10:14 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Potency correction - Only in exceptional cases d_labes 2018-06-23 18:04
- Potency correction - Only in exceptional cases ElMaestro 2018-06-23 19:55
- Potency correction: Rather why than when Helmut 2018-06-24 00:55
- Potency correction: Rather why than when ElMaestro 2018-06-25 10:22
- Potency correction: Upper limit? Helmut 2018-06-25 15:34
- Potency correction: Rather why than when ElMaestro 2018-06-25 10:22
- Potency correction - Example d_labes 2018-06-24 14:40
- Potency correction: Rather why than when Helmut 2018-06-24 00:55
- Potency correction - Only in exceptional cases ElMaestro 2018-06-23 19:55
- Potency correction - EAUnion opinion mittyri 2018-06-23 22:53
- Potency correction - example Ohlbe 2018-06-25 10:10
- Let me answer my own question ElMaestro 2018-06-25 18:24
- Someone, somebody - slightly OT d_labes 2018-06-25 19:49
- Potency correction - Only in exceptional cases d_labes 2018-06-23 18:04
Ing. Helmut Schütz