[HTML][HTML] Design of experiments (DoE) applied to pharmaceutical and analytical quality by design (QbD)
IM Fukuda, CFF Pinto, CS Moreira… - Brazilian journal of …, 2018 - SciELO Brasil
According to Quality by Design (QbD) concept, quality should be built into product/method
during pharmaceutical/analytical development. Usually, there are many input factors that …
during pharmaceutical/analytical development. Usually, there are many input factors that …
Mammalian cell culture for production of recombinant proteins: A review of the critical steps in their biomanufacturing
The manufacturing of recombinant protein is traditionally undertaken in mammalian cell
culture. Today, speed, cost and safety are the primary considerations for process …
culture. Today, speed, cost and safety are the primary considerations for process …
TQM, SCM and operational performance: an empirical study of Indian pharmaceutical industry
S Sharma, S Modgil - Business Process Management Journal, 2020 - emerald.com
Purpose The purpose of this paper is to investigate the impact of total quality management
(TQM) and supply chain management (SCM) practices on operational performance, and …
(TQM) and supply chain management (SCM) practices on operational performance, and …
[HTML][HTML] Question-based review for pharmaceutical development: An enhanced quality approach
A Simões, F Veiga, C Vitorino - European Journal of Pharmaceutics and …, 2024 - Elsevier
Over the last years, the pharmaceutical industry has faced real challenges regarding quality
assurance. In this context, the establishment of more holistic approaches to the …
assurance. In this context, the establishment of more holistic approaches to the …
Development and optimization of liquid chromatography analytical methods by using AQbD principles: Overview and recent advances
T Tome, N Žigart, Z Časar… - Organic process research …, 2019 - ACS Publications
This review presents the Analytical Quality by Design (AQbD) concept, an extension of
Quality by Design (QbD), which was introduced in 2004 by the US Food and Drug …
Quality by Design (QbD), which was introduced in 2004 by the US Food and Drug …
Systematic screening of pharmaceutical polymers for hot melt extrusion processing: A comprehensive review
Pharmaceutical research, whether industrial or academic, has attempted to adopt
approaches most efficient for the development of innovations. With the abundance of …
approaches most efficient for the development of innovations. With the abundance of …
Quality by design (QbD) approaches in current pharmaceutical set-up
ABSTRACT Introduction: Quality by design (QbD) encourages the pharmaceutical industry
to use risk management and science-based manufacturing principles to gain process and …
to use risk management and science-based manufacturing principles to gain process and …
[HTML][HTML] Hot-melt extrusion in the pharmaceutical industry: toward filing a new drug application
MF Simões, RMA Pinto, S Simões - Drug Discovery Today, 2019 - Elsevier
The pharmaceutical development of amorphous solid dispersions (ASDs) by hot-melt
extrusion (HME) is briefly reviewed. A systematic step-by-step approach is presented, where …
extrusion (HME) is briefly reviewed. A systematic step-by-step approach is presented, where …
New trends in the quality control of enantiomeric drugs: quality by design-compliant development of chiral capillary electrophoresis methods
Capillary electrophoresis (CE) is a potent method for analyzing chiral substances and is
commonly used in the enantioseparation and chiral purity control of pharmaceuticals from …
commonly used in the enantioseparation and chiral purity control of pharmaceuticals from …
Drilling into “Quality by Design” approach for analytical methods
L Chiarentin, C Gonçalves, C Augusto… - Critical Reviews in …, 2024 - Taylor & Francis
The need for consistency in analytical method development reinforces the dependence of
pharmaceutical product development and manufacturing on robust analytical data. The …
pharmaceutical product development and manufacturing on robust analytical data. The …