Bioequivalence and Bioavailability Forum • LLOQ / Cmax

LLOQ / Cmax [GxP / QC / QA]

posted by Helmut – Vienna, Austria, 2008-11-24 13:54 (6013 d 07:54 ago) – Posting: # 2787
Views: 20,157

Dear Shankar,

please read Ohlbe's post first! Since you have agreed to comply with the Forum's policy during registration, I will block your account if you fail to do so.

❝ I could not find in guidelines the criterial for selecting LLOQ.

Did you search the Guideline collection? In many guidelines it's mentioned that AUC_T/AUC_inf >80% AUC_inf. With knowledge of the pharmacokinetics of the drug and it's variability it's up to you to come up with a suitable working range for the method (both ULOQ and LLOQ).

❝ Some articles mention it to by 1/100 to 1/32 of the Cmax and some authors used that too.

Stupid enough.

❝ And industry practice seems to be 5%-10 % or Cmax.

ACK, but stupid as well.

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Complete thread:

QA Training vish14184 2008-11-15 09:35
- QA Training: SOPs, protocol Ohlbe 2008-11-15 13:16
  - QA Training: SOPs, protocol chidambarajoshi 2008-11-17 11:08
    - QA Training: SOPs, protocol vish14184 2008-11-18 09:12
      - QA Training: SOPs, protocol mbshankar 2008-11-18 11:31
        
        QA Training: SOPs, protocol chidambarajoshi 2008-11-18 12:00
        
        QA Training: SOPs, protocol mbshankar 2008-11-18 12:43
        
        QA Training: SOPs, protocol chiragkhatri 2008-11-19 05:56
        
        QA Training: SOPs, protocol chidambarajoshi 2008-11-19 07:28
        
        QA Training: SOPs, protocol mbshankar 2008-11-19 10:43
        
        QA Training: SOPs, protocol chidambarajoshi 2008-11-19 11:45
        QA Training: SOPs, protocol chidambarajoshi 2008-11-19 11:47
        
        QA Training: SOPs, protocol mbshankar 2008-11-20 06:46
        
        QA Training: SOPs, protocol vish14184 2008-11-20 09:37
        QA Training: SOPs, protocol chidambarajoshi 2008-11-21 05:43
        
        QA Training: SOPs, protocol mbshankar 2008-11-22 05:09
        
        QA Training: SOPs, protocol chidambarajoshi 2008-11-24 11:22
        
        QA Training: SOPs, protocol mbshankar 2008-11-24 12:22
        
        QA Training: SOPs, protocol Ohlbe 2008-11-24 12:41
        QA Training: SOPs, protocol chidambarajoshi 2008-11-24 12:49
        LLOQ / CmaxHelmut 2008-11-24 12:54