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Quality by Design (QbD)-Based Process Development for Purification of a Biotherapeutic
Trends in Biotechnology, 2016Quality by Design (QbD) is currently receiving increased attention from the pharmaceutical community. As a result, most major biotech manufacturers are in varying stages of implementing QbD. Here, I present a case study that illustrates the step-by-step development using QbD of a purification process for the production of a biosimilar product ...
Anurag S Rathore
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Quality by design (QbD) approaches in current pharmaceutical set-up
Expert Opinion on Drug Delivery, 2018Quality by design (QbD) encourages the pharmaceutical industry to use risk management and science-based manufacturing principles to gain process and product understanding and thus assures quality of the product. With the objective to curb the rising costs for development and regulatory barriers to innovation and creativity, QbD is being widely promoted
Vijay, Mishra +3 more
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Quality by Design (QbD) application for the pharmaceutical development process
Journal of Pharmaceutical Investigation, 2022Sang-Ho Lee +5 more
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A Review on: Quality by Design (QbD)
Asian Journal of Research in Pharmaceutical Science, 2017Quality by Design is the modern approach for quality of pharmaceuticals. Recent pharmaceutical regulatory documents have stressed the critical importance of applying quality by design (QbD) principles for in-depth process understanding to ensure that product quality is built in by design.
Vrushali R. Kadam +3 more
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Quality by design (QbD) approach to match tablet glossiness
Pharmaceutical Development and Technology, 2020A quality by design (QbD) approach was used for a polyvinyl alcohol (PVA)-based coating to develop a 'look-alike' placebo tablet, which can match the glossiness (shine) of an innovator tablet. Critical coating parameters such as exhaust temperature, drying capacity, solid concentration in coating dispersion, and plasticizer concentration were studied ...
Niyaz, Mansuri +7 more
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The Evolution of Quality by Design (QbD) for Biologics
PDA Journal of Pharmaceutical Science and Technology, 2014In recent years, regulators have recognized the need for more controls in drug manufacturing processes. Quality by design is a science- and risk-based approach to drug product development and several pilot programs are ongoing to evaluate enhanced drug development strategies.
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Quality by Design and the Importance of PAT in QbD
2011Abstract This chapter clearly describes the modern philosophy for pharmaceutical drug product development and manufacturing beginning with the identification of core regulatory documents that define cGMPs for the twenty-first century, process analytical technology (PAT) and quality by design (QbD).
Robert W. Bondi, James K. Drennen
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