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Hi Martin,
OK. On basis of the info provided I am guessing that you could make a CI for the Test batches -each of them- and show that each CI spans over the PE for the single ref batch. You can plot CI limits and test's PE's as function of batch number (or better time of production?) and add a horizontal line depicting the ref.'s PE. The alphas prolly need qualification so that regulators know that you do not just chose the one that ensures that all CI's span across the ref's PE.
❝ I would be really glad to get some ideas and suggestions!
❝ PPS.: it's a biologic - QbD 
OK. On basis of the info provided I am guessing that you could make a CI for the Test batches -each of them- and show that each CI spans over the PE for the single ref batch. You can plot CI limits and test's PE's as function of batch number (or better time of production?) and add a horizontal line depicting the ref.'s PE. The alphas prolly need qualification so that regulators know that you do not just chose the one that ensures that all CI's span across the ref's PE.
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Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- In-vitro equivalence martin 2012-05-17 15:10
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- In-vitro equivalence ElMaestro 2012-05-19 01:35
- In-vitro equivalence martin 2012-05-19 10:28
- In-vitro equivalenceElMaestro 2012-05-19 13:55
- In-vitro equivalence Alex 2012-05-22 11:10
- In-vitro equivalence ElMaestro 2012-05-22 14:08
- In-vitro equivalence martin 2012-05-22 17:00
- In-vitro equivalence ElMaestro 2012-05-22 18:36
- In-vitro equivalence martin 2012-05-22 17:00
- In-vitro equivalence ElMaestro 2012-05-22 14:08
- In-vitro equivalence Alex 2012-05-22 11:10
- In-vitro equivalenceElMaestro 2012-05-19 13:55
- In-vitro equivalence martin 2012-05-19 10:28
- In-vitro equivalence ElMaestro 2012-05-19 01:35
Ing. Helmut Schütz