Quality Tolerance Limits’ Place in the Quality Management System and Link to the Statistical Trial Design: Case Studies and Recommendations from Early Adopters

Since the release of ICH E6(R2), multiple efforts have been made to interpret the requirements and suggest ways of implementing quality tolerance limits (QTLs) alongside existing risk-based quality management methodologies. While these efforts have contributed positively to developing a common under...

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Detalles Bibliográficos
Autores principales: Wolfs, Marion, Bojarski, Łukasz, Young, Steve, Cesario, Lynne, Makowski, Marcin, Sullivan, Linda B.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2023
Materias:
Review
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10276776/
https://www.ncbi.nlm.nih.gov/pubmed/36972010
http://dx.doi.org/10.1007/s43441-023-00504-6

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