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Created by Former user, last modified by Former user on Jul 21, 2022
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Project Scope - Define role of QTLs in QbD, in particular the relationship to CTQs (Critical to Quality Factors), Estimands and continuous quality improvement (CQI)
- Discuss the use of QTLs in Early Development/small studies, bio equivalence and complex designs
- Discuss examples of how to define QTLs, different methodologies and different parameters in use across the industry
- Discuss difficulties and challenges of implementation of QTLs
- Examine role of QTLs as part of the of the lessons learned (RCA) feedback loop
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Objectives & Deliverables | Timelines |
Release of draft White Paper | Q3 2022 |
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Project are working on draft white paper. |
Project Members | Organisation |
Alicja Mark | Genmab |
Andrew McGowan | RHO World |
Andrzej Kinasiewicz | AstraZeneca |
Anne Lawrence | AbbVie |
Ansalan Stewart | FDA |
Arati Todkar | TCS |
Barbara Seider | Zealand Pharma |
Chonna Campbell | Unither Pharmaceuticals |
Crupa Kurien | Pfizer |
Debra Jendrasek | DSI |
Georgina Wood | Cyntegrity |
Heidi Hoffman | Genentech |
Jean Mulinde | FDA |
Julie Appel | Novo Nordisk |
Karen Bleich | FDA |
Kate Tomlinson | PRISM |
Katherine Taylor | Merck |
Kevin Douglass | DSI |
Linda Del Paggio | Genentech |
Lukasz Bojarski | AstraZeneca |
Lynne Cesario | Pfizer |
Mary Arnould | Astellas |
Project Members | Organisation |
Michael Walega | Bristol Myers Squibb |
Mireille Lovejoy | Roche |
Monika Moersch | Boehringer-Ingelheim |
Mukesh Babu | Industry |
Nathalie Van Borrendam | Janssen Research & Development |
Nick Wells | Syneos Health |
Paul Brown | Danish Medicines Agency |
Priti Gupta | Pfizer |
Sally Wynn | Novartis |
Shalaka Gadhave | TCS |
Sheetal Chandarana | Roche |
Steve Young | CluePoints |
Steven Gilbert | Pfizer |
Problem Statement QTLs - the role they play in defining quality within the QbD framework, their relationship to Critical to Quality factors, associated methodologies and the interpretation of them have not been fully defined in clinical development, in particular where early development/small studies, bio equivalence studies and complex designs are concerned. Problem Impact This will impact the whole clinical development process and allow the move away from perfection to a defined and achievable quality, from which continuous quality improvement can begin. |
| Terminology Example: - Target Product Profile (TPP)
- Patient wants extended dosing from current BD product on market
- Critical Quality Attribute (CQA)
- Critical to Quality Factor (CTQ)
- In early stage trials drug levels shown at 24 hours
- In Phase 2-3 demonstrate efficacy
- Quality Tolerance Limit
- Pre-define what will be acceptable limits for acceptance
- These QTL's will change at different stages
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