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RegisterCmax for enteric coated product [Regulatives / Guidelines]
Hi Ken Peh,
Yes, either that, or perhaps you can do scaling in a study with replication of the ref and observed CV>30%. If you opt for a 2-stage design then you might be dealing with an e.g. 94.12% CI rather than 90% CI etc.
You may have some options here but I think Cmax must show BE one way or another almost regardless of where you intend to submit.
❝ For enteric coated tablets, there is a lag time in the absorption. The lag time varies a lot in the same subject for two different treatment and also between subjects. For this type of product, it it a must to follow the 90%CI limit of 0.80 -1.25 ?
Yes, either that, or perhaps you can do scaling in a study with replication of the ref and observed CV>30%. If you opt for a 2-stage design then you might be dealing with an e.g. 94.12% CI rather than 90% CI etc.
You may have some options here but I think Cmax must show BE one way or another almost regardless of where you intend to submit.
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Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Cmax for enteric coated product Ken Peh 2014-04-13 07:08
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Cmax for enteric coated productElMaestro 2014-04-13 09:21
- Cmax for enteric coated product jag009 2014-04-14 15:44
Ing. Helmut Schütz