Bioequivalence and Bioavailability Forum • QA Training: SOPs, protocol

QA Training: SOPs, protocol [GxP / QC / QA]

posted by mbshankar – 2008-11-24 13:22 (6418 d 21:01 ago) – Posting: # 2782
Views: 25,391

Dear Joshi,
I could not find in guidelines the criterial for selecting LLOQ. Some articles mention it to by 1/100 to 1/32 of the Cmax and some authors used that too. And industry practice seems to be 5%-10 % or Cmax.
And regarding QA I found that persons from GMP back grownd (staff or sponsors) tend to involve QA more into the activites. One can feel it while facing sponsor and third party audits. Your comments please
Regards

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Edit: Full quote removed. Please see this post! [Ohlbe]

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, protocolmbshankar 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 / Cmax Helmut 2008-11-24 12:54