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Project Scope 

The Project has successfully completed the first step of clarifying the definitions and labels linked to QTL monitoring. Recommendations on how to derive thresholds for QTL monitoring have been developed.  

The next stage shall be to: 

  • Share this acquired knowledge and common understanding within the industry. 
  • Continue the discussion on further refining the (statistical) methodology regarding threshold derivation for QTL monitoring. 

Closely follow ICH (R3) developments regarding risk-based monitoring and discuss/evaluate whether this has impacts on the guidance provided so far (QTL vs. acceptable range). 



Project LeadsEmail
Nathalie van Borrendam, Johnson & Johnsonnvanborr@its.jnj.com
Annett Keller, Boehringer Ingelheim annett.keller@boehringer-ingelheim.com
Alex Pearce, PHUSE Project Assistant 

Alexandra@phusealexandra@phuse.global


  • Submitted abstract for the PHUSE US Connect 2024. 
  • Applied for workshop at the PHUSE US Connect 2024. 
  • Development of second white paper.  
    • First paper accepted at TIRS. 

    Status
    colourBlue
    titleCurrent Status
    Q3 2023

    Q4 2024

    • Establish draft paper.



    Objectives & DeliverablesTimelines
    Challenges in QTL threshold setting – Experience sharing and high-level recommendations for the industryQ3 2022

    Guidance document on QTL threshold-setting methodologies

    		Q1 2023