Bioequivalence and Bioavailability Forum • Cmin-value <LLOQ

Cmin-value <LLOQ [Surveys]

posted by beman – 2010-01-04 16:43 (6001 d 11:52 ago) – Posting: # 4557
Views: 16,184

Hi,

I define the Cmin-Value in multiple dose bioequivalence studies as the 'Last concentration within the dosing interval'.

If the last value in the dosing interval is <LLOQ, which value should i use?

If i set the value to zero, the ratio T/R can't be calculated.
I can calculate a value <LLOQ (with the average half life time of the corresponding single dose study or the literature).
I can use the Last concentration value >=LLOQ (for both the reference and the test formulation)
I can use the Last concentration value >=LLOQ (for only one formulation, for the other i use the last concentration value).

thank you

beman

Edit: Linked to another thread. See the Policy. [Helmut]

Complete thread:

Cmin (EU) Helmut 2009-12-21 13:08
- Cmin (EU) ElMaestro 2009-12-22 14:17
  - Terminology issues Helmut 2009-12-22 14:30
    - Philostics ElMaestro 2009-12-27 00:47
      - Philostics Helmut 2009-12-27 02:01
        
        Philostics ElMaestro 2009-12-27 13:28
        
        Philostics Helmut 2009-12-27 15:07
        
        Philostics ElMaestro 2009-12-28 02:46
- Cmin (EU) d_labes 2010-01-04 10:45
  - Repeated profiles Helmut 2010-01-04 13:53
- Cmin-value <LLOQbeman 2010-01-04 15:43
  - Cmin-value <LLOQ Helmut 2010-01-04 16:34