Bioequivalence and Bioavailability Forum • multilayer tablet exclusion criteria from PK analysis due to emesis

multilayer tablet exclusion criteria from PK analysis due to emesis [Regulatives / Guidelines]

posted by jag009 – NJ, 2016-01-30 00:02 (3341 d 03:49 ago) – Posting: # 15899
Views: 3,856

Hi Shuanghe,

But does it matter if it's IR/XR with a single API or IR with API A and XR with API B?
The emesis criteria should be based on the IR Tmax. Okay, unless there is an IR product out there which has a really long Tmax such that it's actually longer than the dosing interval of the modified release.

Thanks
John

Complete thread:

multilayer tablet exclusion criteria from PK analysis due to emesis Mahesh M 2016-01-08 10:56 [Regulatives / Guidelines]
- multilayer tablet exclusion criteria from PK analysis due to emesis Mahesh M 2016-01-13 12:46
  - multilayer tablet exclusion criteria from PK analysis due to emesis jag009 2016-01-26 17:56
    - tmax IR > tmax MR? Dr_Dan 2016-01-28 08:57
      - tmax IR > tmax MR? jag009 2016-01-29 22:51
- multilayer tablet exclusion criteria from PK analysis due to emesis Shuanghe 2016-01-28 13:00
  - multilayer tablet exclusion criteria from PK analysis due to emesisjag009 2016-01-29 23:02
    - multilayer tablet exclusion criteria from PK analysis due to emesis Shuanghe 2016-02-01 11:01
      - multilayer tablet exclusion criteria from PK analysis due to emesis Mahesh M 2016-02-01 13:14