Bioequivalence and Bioavailability Forum

Profiles with no measurable concentrations [Outliers]

posted by Dr_Dan  – Germany, 2011-10-06 16:22 (4261 d 04:32 ago) – Posting: # 7431
Views: 7,343

Dear Stefano
first of all before discussing how to calculate PK parameters I would suggest to find out the reason for obtaining profiles with no measurable concentrations.

• Is the bioanalytical method sensitiv enough?
  
• What about subject compliance?
  
• Has the drug a high inter-subject variability?
  
• Is this phenomenon observed after test and reference application?
  
• Does this phenomenon occur in both periods of a subject or just in one?

Maybe it is worthless to think about statistical evaluation.... 
Kind regards
Dan

Complete thread:

• Profiles with no measurable concentrations vezz 2011-10-06 12:45 
  • Profiles with no measurable concentrationsDr_Dan 2011-10-06 14:22
    • Profiles with no measurable concentrations ElMaestro 2011-10-06 17:45
  • ask the EMA oracle d_labes 2011-10-06 15:24
    • ask the EMA oracle Ohlbe 2011-10-06 16:31
  • Profiles with no measurable concentrations Helmut 2011-10-06 19:14