Bioequivalence and Bioavailability Forum

drug concentration nil in both periods [Study Assessment]

posted by VP – 2009-10-14 11:10 (5306 d 21:25 ago) – Posting: # 4350
Views: 4,658

Dear All

we have conducted one BA/BE study, in which dosing procedure was followed as per protocol. But in bioanalytical analysis for one subject drug concentration was nil for both periods. we excluded that subject from stastical analysis.
How to report same in integrated (clinical) report?

Regards
Vidya

Edit: Category changed. [Helmut]

Complete thread:

drug concentration nil in both periodsVP 2009-10-14 09:10
- drug concentration <LLOQ in both periods Helmut 2009-10-14 13:51
  - drug concentration <LLOQ in both periods VP 2009-10-15 12:35
    - drug concentration <LLOQ in both periods SDavis 2009-10-15 13:18
    - drug concentration <LLOQ in both periods Helmut 2009-10-15 13:55
      - drug concentration <LLOQ in both periods VP 2009-10-15 14:13

drug concentration nil in both periods [Study As­sess­ment]

Complete thread:

drug concentration nil in both periods [Study Assessment]