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RegisterPartial replicate design & ABE for the FDA [Design Issues]
❝ I asked numerous times here and in Certara’s Extranet why one wants to use a partial replicate design – and never received an answer. 
One guy told me: I'm not going to determine any parameter that is
a - not asked for by authorities
b - might put my product (now or in the furture...) in a bad light compared to reference
In the very beginning of this scaling discussion someone stated (regarding replicate for Reference): "Why should I characterize the REFERENCE product? This should f**ing do the originator!" No joke...
—
Kindest regards, nobody
Kindest regards, nobody
Complete thread:
- Replicate designs VSL 2017-01-31 06:47 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Replicate designs: Pros & Cons Helmut 2017-01-31 12:42
- Replicate designs: Pros & Cons VSL 2017-01-31 14:03
- Replicate designs: Pros & Cons Balaji 2017-03-04 11:19
- Partial replicate design & ABE for the FDA Helmut 2017-03-06 11:40
- Partial replicate design & ABE for the FDAnobody 2017-03-06 13:47
- Partial replicate design & ABE for the FDA Helmut 2017-03-06 14:00
- Partial replicate design & ABE for the FDA nobody 2017-03-06 14:18
- Partial replicate design & ABE for the FDA Helmut 2017-03-06 17:49
- Partial replicate design & ABE for the FDA nobody 2017-03-06 14:18
- Partial replicate design & ABE for the FDA Helmut 2017-03-06 14:00
- Partial replicate design & ABE for the FDAnobody 2017-03-06 13:47
- Partial replicate design & ABE for the FDA Helmut 2017-03-06 11:40
- Replicate designs: Pros & Cons Helmut 2017-01-31 12:42
Ing. Helmut Schütz