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, 2016-01-08 11:56 (3362 d 17:19 ago) – Posting: # 15803
Views: 5,973

Dear All,

My concern regarding multilayer tablet one API is IR and another is XR (combination of IR and XR) what is the exclusion criteria of subjects form PK analysis due to the emesis for FDA submission? Can we use different criteria for IR and XR as per FDA guidance or this combination product consider as modified release dosage form?

Regards
M

Complete thread:

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