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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


Status
colourBlue
titleCurrent Status
Q3 2023 Q2 2024

  • Presented paper outcomes at Phuse US Connect Feb 2024 
  • Presented paper outcomes to the Phuse-FDA meeting in March 2024
  • 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.  



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