Quality by Design (QbD) application for the pharmaceutical development process

SH Lee, JK Kim, JP Jee, DJ Jang, YJ Park… - Journal of …, 2022 - Springer
Abstract Background Quality by Design (QbD) is a pharmaceutical quality management
system that predicts, controls, and systematically responds to risks that may occur in the …

Quality by Design (QbD) and Design of Experiments (DOE) as a Strategy for Tuning Lipid Nanoparticle Formulations for RNA Delivery

L Gurba-Bryśkiewicz, W Maruszak, DA Smuga… - Biomedicines, 2023 - mdpi.com
The successful development of nonviral delivery systems for nucleic acids has been
reported extensively over the past years. Increasingly employed to improve the delivery …

[PDF][PDF] Effect of mannitol particle size on melatonin dissolution and tablet properties using a quality by design framework

B Mesut, YP Tok, B Alkan, MK Vefai… - Dissolution …, 2023 - researchgate.net
The objective of the current study was to develop an optimized formulation for orally
disintegrating tablets (ODTs) containing melatonin. Different particle sizes of mannitol (ie …

Formulation design of the oral disintegrating tablets including alfuzosin hydrochloride with risk evaluation via quality by design

G Güncan, G Yeğen, B Mesut, B Aksu, Y Özsoy - 2017 - openaccess.altinbas.edu.tr
In this study, within the framework of Quality by Design which is a systematically scientific
approach which enables to understand and control the production and formulation variables …

[图书][B] Introduction to Quality by Design (QbD): From Theory to Practice

NK Jain, N Bajwa - 2024 - books.google.com
This book offers a comprehensive exploration of the Quality by Design (QbD) methodology,
guiding readers from theory to practical application with accessible examples. It equips …

Evaluation of emulgel formulations contain diclofenac sodium via quality by design approach

M Kalayi, G Yeğen, NÜ Okur, B Aksu - 2022 - openaccess.altinbas.edu.tr
Emulgel is considered as emulsions, either oil-in-water or water-in-oil type, that is formed via
blending with a gelling agent. Their common usage as pharmaceutical dosage form results …

Global regulatory perspectives on quality by design in pharma manufacturing

B Aksu, G Yeğen - Pharmaceutical Quality by Design, 2019 - Elsevier
The legislations have almost frozen the processes used in pharmaceutical manufacturing
overtime. Even after the receipt of drugs' permits/certificates, even a small change in the …

Examining the basic principles of quality by design (QbD) approach in analytical studies

B Mesut, C Önal, B Aksu, Y Özsoy - Istanbul Journal of Pharmacy, 2021 - dergipark.org.tr
Although the first application of Quality by Design (QbD) concept started for product
development studies, the number of studies regarding its application to analytical …

Quality by Design and Marketing

V Kumar, S Nishal, P Phougat, V Garg… - Introduction to Quality by …, 2024 - Springer
Critical scientific, technological, and regulatory constraints in pharmaceuticals' study,
development, and marketing must be addressed using a more comprehensive, systematic …

Quality By Design in Quality Assurance

S Nishal, P Phaugat, M Gulia, V Jhawat - … to Quality by Design (QbD) From …, 2024 - Springer
Juran introduced the concept of quality by design (QbD) initially, who held view that quality
ought to be scheduled and believed that the majority of quality crises and issues stem form …