Results 1 to 10 of about 3,100 (179)
146 Applying and evaluating an enhanced “Quality by Design” program across the translational science spectrum [PDF]
Journal of Clinical and Translational ScienceObjectives/Goals: To implement and evaluate the Quality by Design (QbD) framework integrating team science and project management to increase quality and efficiency in clinical and translational studies. Goals include achieving 80% on-time completion and
Cathelin Huang +5 more
doaj +2 more sources
Journal of Excipients and Food Chemicals, 2016 The misapplication of QbD for purposes for which it was not intended for is unwise andlikely to be counterproductive. It would be a shame if, by virtue of such misapplication, the QbD paradigm were to be maligned or abandoned, because there is no denying
Shireesh Apte
doaj +3 more sources
Biomedicines, 2023 The successful development of nonviral delivery systems for nucleic acids has been reported extensively over the past years. Increasingly employed to improve the delivery efficiency and therapeutic efficacy of RNA are lipid nanoparticles (LNPs).
Wioleta Maruszak +2 more
exaly +3 more sources
Blockchain-enabled quality by design system for clinical trials [PDF]
Frontiers in MedicineIntroductionBlockchain technology offers a secure and distributed approach to data management that can strengthen the Quality by Design (QbD) framework in clinical trials. Integrating blockchain with QbD can enhance data integrity and promote participant
Reza Vatankhah Barenji +1 more
doaj +2 more sources
Journal of Excipients and Food ChemicalsThe misapplication of QbD for purposes for which it was not intended for is unwise andlikely to be counterproductive. It would be a shame if, by virtue of such misapplication, the QbD paradigm were to be maligned or abandoned, because there is no denying
Shireesh Apte
doaj +1 more source
Protocol for applying an enhanced quality-by-design program across the translational science spectrum [PDF]
Journal of Clinical and Translational ScienceThe quality by design (QbD) framework holds promise for improving success rates for completion of clinical studies, which often fail to complete on time.
Allison Zumberge Orechwa +12 more
doaj +2 more sources
Design Space and QbD Approach for Production of Drug Nanocrystals by Wet Media Milling Techniques
Pharmaceutics, 2018 Drug nanocrystals are nanosized solid drug particles, the most important application of which is the improvement of solubility properties of poorly soluble drug materials.
Leena Peltonen
exaly +3 more sources
A hybrid innovation method based on quality by design and agile scrum paradigms for the development of medicinal products [PDF]
Scientific ReportsThis 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.
Thierry Bastogne +4 more
doaj +2 more sources
Excipients functionality: Importance and compendial status [PDF]
Arhiv za farmaciju, 2016 Traditional understanding of excipients as simple, inert and inactive ingredients of pharmaceutical preparations was changed when it became clear that they may significantly affect quality, safety and efficacy of pharmaceutical preparations.
Milić Jela +2 more
doaj +1 more source
408 Quality by Design: A Framework for Study Success
Journal of Clinical and Translational Science, 2023 OBJECTIVES/GOALS: The SC CTSI Quality by Design (QbD) program aims to improve the execution of clinical research studies identifying and addressing possible issues before implementation.
Allison Orechwa +2 more
doaj +1 more source