Results 71 to 80 of about 62,558,702 (211)
Consideration Without Economic Duress: Reframing the Analysis of Contractual Modifications
Prevailing approaches to the contractual enforceability of modifications revise or dispense with the requirement of consideration and invoke economic duress to rule out unfair, inequitable, or bad faith modifications. Enforceability turns effectively on the absence of economic duress. But economic duress is a doctrine of avoidance.
Peter Benson
wiley +1 more source
Blockchain-enabled quality by design system for clinical trials
IntroductionBlockchain 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 +1 more source
Quality by Design (QbD) and Quality Risk Management
Quality by Design (QbD) and Quality Risk Management (QRM) are modern scientific approaches that ensure pharmaceutical products are consistently safe, effective, and of high quality. Unlike traditional quality control methods that rely mainly on end-product testing, QbD emphasizes building quality into the product during development by understanding ...
Achyut Holagi +2 more
openaire +1 more source
Abstract This study presents a coupled population balance model (PBM) for describing the degree‐of‐agglomeration (DoA) in crystallization by independently tracking total particle and agglomerate number densities. Applied to an industrial active pharmaceutical ingredient, the model outperformed bridge‐counting methods and accurately captured DoA trends ...
Yung‐Shun Kang +6 more
wiley +1 more source
Beyond Blind Trust in Hospital Data Warehouses: Evaluating Real‐World Data Accountability
ABSTRACT Introduction The reliability of real‐world evidence (RWE) depends on data accuracy and secondary users' ability to evaluate how data are generated and transformed. Although recent frameworks emphasize provenance, transparency, and auditability, their practical assessment in routine hospital settings remains unclear.
Akemi Morohashi +6 more
wiley +1 more source
Application of quality by design (qbd) to reformulation of chewable tablets [PDF]
This research work illustrates the implementation of Quality by Design (QbD) principles into pharmaceutical industry. The manufacture of chewable tablets was chosen as case study.
Mora Huertas, Claudia Elizabeth +2 more
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Surface‐modified niosomes are introduced as multifunctional nanoparticles for precision tumor treatment that combine hydrophilic and lipophilic drug encapsulation with ligand‐based targeting via antibodies, peptides, transferrin, and folic acid. This modification leads to increased tumor selectivity, facilitates cell entry, and enables enhanced ...
Narges Sahraei +3 more
wiley +1 more source
Advances in cell sources, bioengineering, and manufacturing are reshaping the design of skin substitutes. This review highlights emerging strategies driving skin tissue engineering and discusses their potential to enable safer, reproducible, and clinically accessible skin substitutes for regenerative medicine.
Gilles Lemaître +7 more
wiley +1 more source
Magnetically responsive nanoparticles enable remote control over biomaterials, cells, and engineered tissues. This review summarizes material design, biological safety, fabrication and actuation strategies, computational validation, and translational pathways that support the development of magnetic tissue‐engineering platforms and future magnetically ...
Konstantinos Ioannidis +8 more
wiley +1 more source
A Quality by Design alkalmazása a gyógyszerkészítmények fejlesztése során
A diplomamunka a gyógyszerek fejlesztésének, és gyártásának új modelljével, a Quality by Design-al foglalkozik. Bemutatja a még jelenleg alkalmazott QbT modellt, és összehasonlítja ezzel az új modellel. Részletesen ismerteti a QbD elemeit, és előnyeit. A
Biró, Lajos
core

