Potency correction - Only in exceptional cases [Regulatives / Guidelines]
Dear ElMaestro,
read the Section again. It states unambigously:
"In bioequivalence studies, the pharmacokinetic parameters should in general not be adjusted for differences in assayed content of the test and reference batch."
That was the policy which my former company followed over years. Ended with the publication of the 2010 guideline.
This is indeed
But reading the next sentence:
"However, in exceptional cases where a reference batch with an assay content differing less than 5% from test product cannot be found (see section 4.1.2) content correction could be accepted ..."
Emphasis by me.
Imagine for example there is no reference product of 50 µg content, no one produces the 50 µg formulation any longer, but only one with 60 µg. And the patient is optimally prescribed a dose of 50 µg. Having such a formulation with 50 µg is a benefit for the patient, I think.
❝ section 4.1.8 of the EMA guideline opens up for potency calculation for BE evaluation.
❝ ...
read the Section again. It states unambigously:
"In bioequivalence studies, the pharmacokinetic parameters should in general not be adjusted for differences in assayed content of the test and reference batch."
That was the policy which my former company followed over years. Ended with the publication of the 2010 guideline.
This is indeed
❝ ... 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 reading the next sentence:
"However, in exceptional cases where a reference batch with an assay content differing less than 5% from test product cannot be found (see section 4.1.2) content correction could be accepted ..."
Emphasis by me.
❝ I still can't [...] see in which way that opportunity does anything good for the sake of the EU patient.
Imagine for example there is no reference product of 50 µg content, no one produces the 50 µg formulation any longer, but only one with 60 µg. And the patient is optimally prescribed a dose of 50 µg. Having such a formulation with 50 µg is a benefit for the patient, I think.
—
Regards,
Detlew
Regards,
Detlew
Complete thread:
- Potency correction - I still don't get it ElMaestro 2018-06-23 10:14 [Regulatives / Guidelines]
- Potency correction - Only in exceptional casesd_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 casesd_labes 2018-06-23 18:04