Project Scope
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Project Leads | |
Andy Lawton | w.a.lawton@aol.co.uk |
Chris Wells | chris.wells.cw1@roche.com |
Wendy Dobson (PHUSE Project Manager) |
Project Members | Organisation |
Crupa Kurien | Pfizer |
Julie Appel | Novo Nordisk |
Mary Arnould | Astellas |
Michael Walega | BMS |
Mireille Lovejoy | Roche |
Steven Gilbert | Pfizer |
Objectives & Deliverables | Timelines |
White Paper | Q22022 |
Publications | Q42021 |
CURRENT STATUS Q22021 |
This is a new project and is actively seeking participation. If you are interested in joining this team, please email workinggroups@phuse.global. |
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:
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