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RegisterT/R potency <5% [Regulatives / Guidelines]
Hi Divyen!
It is not about potency correction, it is about controlling errors wherever possible and designing rationale BE study design. BE studies are meant to detect minor formulation differences, therefore it is better to keep T/R <5% (just compare acceptable variabilities we observe in pharmaceutical dosage form analysis and PK parameters) to improve your BE success probability. I believe I heard (in the 2000 BE workshop) rationale for this 5% difference is to accomodate aging differences (time of manufacture to time of dosing) between Test and RLD (usually RLD is older than Test and also assay variabilities (Damn: everyone blames poor analytical chemist
).
Let us say the ratio is 110% you are already at the top of the limit+ combined with variability associated with Bioanalytical, between subjects and other factors you are shooting for failure (unless luck is on your side).
This is my side of the story
❝ So if the difference is more, there is higher probability to find difference in PK parameters for treatments, which ultimately affects BE outcome.
It is not about potency correction, it is about controlling errors wherever possible and designing rationale BE study design. BE studies are meant to detect minor formulation differences, therefore it is better to keep T/R <5% (just compare acceptable variabilities we observe in pharmaceutical dosage form analysis and PK parameters) to improve your BE success probability. I believe I heard (in the 2000 BE workshop) rationale for this 5% difference is to accomodate aging differences (time of manufacture to time of dosing) between Test and RLD (usually RLD is older than Test and also assay variabilities (Damn: everyone blames poor analytical chemist
).Let us say the ratio is 110% you are already at the top of the limit+ combined with variability associated with Bioanalytical, between subjects and other factors you are shooting for failure (unless luck is on your side).
This is my side of the story
Complete thread:
- T/R potency <5% Achievwin 2022-09-07 18:22 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- T/R potency <5% Helmut 2022-09-07 18:55
- T/R potency <5% Achievwin 2022-09-07 20:50
- T/R potency <5% jag009 2022-09-08 19:54
- T/R potency <5% dshah 2022-09-09 10:48
- T/R potency <5% Helmut 2022-09-09 12:13
- T/R potency <5%Achievwin 2022-09-09 14:56
- T/R potency <5% Helmut 2022-09-09 17:08
- T/R potency <5% dshah 2022-09-09 17:42
- T/R potency <5% Achievwin 2022-09-07 20:50
- T/R potency <5% Helmut 2022-09-07 18:55
Ing. Helmut Schütz