Log in
Register|
Ken Peh ★ Malaysia, 2014-04-13 09:08 (4457 d 01:16 ago) Posting: # 12827 Views: 2,940 |
|
|
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 (4456 d 23:04 ago) @ Ken Peh Posting: # 12828 Views: 2,413 |
|
|
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 (4455 d 16:40 ago) @ Ken Peh Posting: # 12838 Views: 2,494 |
|
|
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 |
Ing. Helmut Schütz