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 Shuanghe – Spain, 2016-02-01 12:01 (3338 d 17:12 ago) – Posting: # 15906
Views: 3,701

Hi John,

The difference is subtle. I would use IR Tmax as criteria if the product is of 1 API with 2 release components IR and ER. If the product is of 2 APIs, A (IR) and B (ER), then I would use separate criteria for each of them. e.g., if subject vomit during dosing interval, exclude for B but depending on when, this subject might (>2 x IR Tmax) or might not (<= 2xIR Tmax) be included for A. All scenarios should be described in detail in protocol of course.

—
All the best,
Shuanghe

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 emesis jag009 2016-01-29 23:02
    - multilayer tablet exclusion criteria from PK analysis due to emesisShuanghe 2016-02-01 11:01
      - multilayer tablet exclusion criteria from PK analysis due to emesis Mahesh M 2016-02-01 13:14