Bioequivalence and Bioavailability Forum • Cmax for enteric coated product

Ken Peh
★

Malaysia,
2014-04-13 09:08
(4461 d 15:45 ago)

Posting: # 12827
Views: 2,968

Cmax for enteric coated product [Regulatives / Guidelines]

Dear All,

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 ?

Your kind comment is highly appreciated.

Thank you.

Regards,
Ken

Please don’t write “RE: ” in the subject line; removed. [Helmut]

ElMaestro
★★★

Denmark,
2014-04-13 11:21
(4461 d 13:32 ago)

@ Ken Peh
Posting: # 12828
Views: 2,430

Cmax for enteric coated product

Post reply

Hi Ken Peh,

❝ 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.

—
Pass or fail!
ElMaestro

jag009
★★★

NJ,
2014-04-14 17:44
(4460 d 07:09 ago)

@ Ken Peh
Posting: # 12838
Views: 2,503

Cmax for enteric coated product

Post reply

Hi Ken,

❝ ...For this type of product, it it a must to follow the 90%CI limit of 0.80 -1.25 ?

Were you referring to 90%CI for Cmax? Yes regardless of the lag time you have to hit Cmax and AUC. There are some products out there which you have to demonstrate similar lag time due to clinical strategy. Example, Covera HS (We submitted this ages ago), we had to demonstrate similar lag time between T&R.

John