Bioequivalence and Bioavailability Forum

Subject non compliance [Study Assessment]

posted by Loky do – Egypt, 2020-07-15 12:57 (105 d 20:12 ago) – Posting: # 21698
Views: 1,018

Dears

if a subject didn't have any evaluable concentrations for only test product all intervals are BLQ and according to our SOPs and SAP, the BLQ is considered "zeros", could be excluded from PK and statistical analysis?

thanks

Edit: Category changed; see also this post #1. [Helmut]

Complete thread:

Subject non complianceLoky do 2020-07-15 12:57 [Study Assessment]
- Subject non compliance (or product failure?) Helmut 2020-07-16 14:30
  - Subject non compliance (or product failure?) Loky do 2020-07-16 22:29
    - Bad science (statistics is taboo) Helmut 2020-07-17 01:01
      - unexpected behavior for test product Loky do 2020-07-22 11:29
        
        Subject-by-Formulation interaction? Helmut 2020-07-22 12:03
        
        Subject-by-Formulation interaction? Loky do 2020-07-26 11:30

Subject non compliance [Study As­sess­ment]

Complete thread:

Subject non compliance [Study Assessment]