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You are currently viewing A hybrid innovation method based on quality by design and agile scrum paradigms for the development of medicinal products

Abstract

This study proposes an agile paradigm of the pharmaceutical Quality by Design (QbD) approach initiated and recommended by regulatory agencies to better understand and control their innovative products and processes throughout the development phase. The primary objective of this hybrid innovation method is to improve the structural organization of the QbD approach to simplify its use and expand its application to the early stages of preclinical development. This agile QbD paradigm relies on the incrementation and/or iteration of short studies called sprints indexed according to the Technological Readiness Level (TRL)

https://www.nature.com/articles/s41598-025-18181-w