Bioequivalence and Bioavailability Forum • PK Vs Analytical

PK Vs Analytical [Bioanalytics]

posted by drshiv – India, 2007-07-31 10:47 (6905 d 07:10 ago) – Posting: # 946
Views: 15,393

Dear Charl,

I hope the following explanation helps you.

Determination of Lower Limit of Quantitation (LLOQ)
LLOQ should be sufficiently low to allow characterization of 4-5 T1/2
AUC0-t/AUCinf ration should be >80% (ie., residual area <20%)
LLOQ should allow proper characterization of baseline levels of endogenous substance (unless they are insignificant, eg., less than 5% of Cmax)
LLOQ values should be less than 5% of observed Cmax
Examples of LLOQ determination methods:
Expected mean Cmax divided by 32 (represents 5 T1/2 assuming a one-compartment model)
Should also be based on the PK profile

Dr. Shiv

Complete thread:

PK Vs Analytical Charl 2007-07-23 10:44
- PK Vs Analytical Helmut 2007-07-23 18:04
  - PK Vs Analytical Charl 2007-07-24 10:31
    - PK Vs Analytical Helmut 2007-07-24 13:42
      - PK Vs Analytical Charl 2007-07-24 15:02
- PK Vs Analyticaldrshiv 2007-07-31 08:47
  - PK Vs Analytical Charl 2007-07-31 14:07
    - PK Vs Analytical drshiv 2007-08-07 16:37
      - NCA 'model independent'? Helmut 2007-08-11 20:09
        
        NCA 'model independent'? drshiv 2007-08-12 13:08
        
        Numerical integration Helmut 2007-08-12 18:51
        
        Numerical integration drshiv 2007-08-14 08:29