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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, bioequivalence 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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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, bioequivalence 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. |