Bioequivalence and Bioavailability Forum

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

posted by Shuanghe  – Spain, 2016-01-28 14:00 (3342 d 15:02 ago) – Posting: # 15877
Views: 3,920

Dear All,

I had a feeling that you guys were talking different things. e.g., asking about oranges and answered about apples.

❝ My concern regarding multilayer tablet one API is IR and another is XR (combination of IR and XR) ...

So I guess that means 1 APIs, compound A is IR and compound B is XR (that seems strange though).

I believe John and Dan were talking about 1 API, compound A, which was formulated part as IR and part as XR so IR part can be released quickly to have quick initial effect and XR part released slowly to maintain the therapeutic effect, which is common for new pain killer formulation.

Depending on which scenario I guess the answer should be different.

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 emesisShuanghe 2016-01-28 13:00
    • multilayer tablet exclusion criteria from PK analysis due to emesis jag009 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