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 Mahesh M – India, 2016-02-01 14:14 (3338 d 14:47 ago) – Posting: # 15908
Views: 3,624

Hi, Shuanghe,

I do agree with your thoughts but if we talk regarding bilayer or multilayer tablet it should consider as modified dosage form.
And if the combination in capsule 1 API is IR tablet and 2 is modified release pallets 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.

Regards

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 emesis Shuanghe 2016-02-01 11:01
      - multilayer tablet exclusion criteria from PK analysis due to emesisMahesh M 2016-02-01 13:14