Results 11 to 20 of about 2,590,147 (263)

Aspects and Implementation of Pharmaceutical Quality by Design from Conceptual Frameworks to Industrial Applications [PDF]

Pharmaceutics
Background/Objectives: Quality by Design (QbD) has revolutionized pharmaceutical development by transitioning from reactive quality testing to proactive, science-driven methodologies.
Shiwei Yang, Xingming Hu, Jinmiao Zhu, Bin Zheng, Wenjie Bi, Xiaohong Wang, Jialing Wu, Zimeng Mi, Yifei Wu   +8 more
doaj   +2 more sources

Quality-by-Design Is a Tool for Quality Assurance in the Assessment of Enantioseparation of a Model Active Pharmaceutical Ingredient

Pharmaceuticals, 2020
The design of experiments (DoE) is one of the quality-by-design tools valued in analytical method development, not only for cost reduction and time effectiveness, but also for enabling analytical method control and understanding via a systematic workflow,
Dina Aboushady, Maria Kristina Parr, Rasha S. Hanafi   +2 more
doaj   +1 more source

QbD Consideration for Developing a Double-Layered Tablet into a Single-Layered Tablet with Telmisartan and Amlodipine

Pharmaceutics, 2022
The aim of this study was to develop a single-layered version of commercially available Twynstar® (Telmisartan + Amlodipine) double-layered tablets to improve the dosing convenience.
Joo-Eun Kim, Young-Joon Park
doaj   +1 more source

Selective Stability Indicating Liquid Chromatographic Method Based on Quality by Design Framework and In Silico Toxicity Assessment for Infigratinib and Its Degradation Products

Molecules, 2023
Infigratinib, a protein kinase inhibitor employed in the therapeutic management of cholangiocarcinoma, was subjected to various stress conditions, including hydrolytic (acidic and alkaline), oxidative, photolytic, and thermal stress, in accordance with ...
Awadh M. Ali, Mohammed M. Alanazi, Mohamed W. Attwa, Hany W. Darwish   +3 more
doaj   +1 more source

Quality-by-design in pharmaceutical development: From current perspectives to practical applications

Acta Pharmaceutica, 2021
Current pharmaceutical research directions tend to follow a systematic approach in the field of applied research and development. The concept of quality-by-design (QbD) has been the focus of the current progress of pharmaceutical sciences. It is based on,
Kovács Béla, Péterfi Orsolya, Kovács-Deák Boglárka, Székely-Szentmiklósi István, Fülöp Ibolya, Bába László-István, Boda Francisc   +6 more
doaj   +1 more source

Risk-Assessment-Based Optimization Favours the Development of Albumin Nanoparticles with Proper Characteristics Prior to Drug Loading

Pharmaceutics, 2022
Albumin nanocarrier research and development is a challenging area in the field of personalized medicine and in providing advanced therapeutic solutions.
Gábor Katona, Bence Sipos, Ildikó Csóka   +2 more
doaj   +1 more source

Evaluation of formulation variables on azithromycin nanoparticles prepared by emulsification solvent diffusion method using quality by design approach [PDF]

Pharmaceutical Sciences Asia, 2022
The study aims to investigate the effect of formulation variables on the characteristics of azithromycin (AZI) nanoparticles using a quality by design approach. AZI nanoparticles were prepared by the emulsification solvent diffusion method.
Nguyen-Thach Tung, Canh-Hung Nguyen, Huu-Manh Nguyen   +2 more
doaj   +1 more source

Process knowledge discovery tools in compliance with Quality by Design concept. [PDF]

Farmacja Polska, 2019
The significant change in the pharmaceutical quality approach (QbD concept, PAT strategy) and focusing on improving the quality of drug products by reducing variability in the manufacturing process force the use of effective tools to discover knowledge ...
Joanna Ronowicz
doaj   +1 more source

Quality-by-design based fabrication of febuxostat-loaded nanoemulsion: Statistical optimization, characterizations, permeability, and bioavailability studies

Heliyon, 2023
The present work deals with QbD-based development of FEB-loaded nanoemulsion (FEB-NE) in order to enhance bioavailability and permeability. In the beginning, the risk assessment was performed on different experimental variables using the Ishikawa diagram
Vishal C. Gurumukhi, Vivek P. Sonawane, Ganesh G. Tapadiya, Sanjaykumar B. Bari, Sanjay J. Surana, Shailesh S. Chalikwar   +5 more
doaj   +1 more source

Development of a Curcumin-Loaded Polymeric Microparticulate Oral Drug Delivery System for Colon Targeting by Quality-by-Design Approach

Pharmaceutics, 2020
The purpose of this study was to apply the quality-by-design (QbD) approach for the development of colon-targeted curcumin-loaded polymeric microparticles (Col-CUR-MPs).
Dana Hales, Lucia Ruxandra Tefas, Ioan Tomuță, Cristian Moldovan, Diana Gulei, Raluca Munteanu, Alina Porfire   +6 more
doaj   +1 more source