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Understanding Pharmaceutical Quality by Design [PDF]
The AAPS Journal, 2014 This review further clarifies the concept of pharmaceutical quality by design (QbD) and describes its objectives. QbD elements include the following: (1) a quality target product profile (QTPP) that identifies the critical quality attributes (CQAs) of the drug product; (2) product design and understanding including identification of critical material ...
Amidon, Gregory +6 more
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Aspects and Implementation of Pharmaceutical Quality by Design from Conceptual Frameworks to Industrial Applications [PDF]
PharmaceuticsBackground/Objectives: Quality by Design (QbD) has revolutionized pharmaceutical development by transitioning from reactive quality testing to proactive, science-driven methodologies.
Shiwei Yang +8 more
doaj +2 more sources
Quality by design for biopharmaceuticals
Nature Biotechnology, 2009 The US Food and Drug Administration's 'quality by design' approach is likely to transform the manufacture of biologics.
Anurag S, Rathore, Helen, Winkle
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Quality by Design: Concepts for ANDAs [PDF]
The AAPS Journal, 2008 Quality by design is an essential part of the modern approach to pharmaceutical quality. There is much confusion among pharmaceutical scientists in generic drug industry about the appropriate element and terminology of quality by design. This paper discusses quality by design for generic drugs and presents a summary of the key terminology. The elements
Robert A, Lionberger +4 more
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Quality by Design for the Nanoformulation of Cosmeceuticals [PDF]
PharmaceuticsCosmeceuticals are cosmetic formulations that are intended to alleviate skin conditions that affect its appearance and functionality. They are not considered medications but contain molecules that exert biological action on the skin beyond traditional ...
Gerardo Leyva-Gómez +6 more
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Important Aspects of the Design of Experiments and Data Treatment in the Analytical Quality by Design Framework for Chromatographic Method Development [PDF]
MoleculesIn the analytical quality by design (AQbD) framework, the design of experiments (DOE) plays a very important role, as it provides information about how experimental input variables influence critical method attributes.
Bianca F. G. Passerine +1 more
doaj +2 more sources
Frontiers in Plant Science, 2022 Lilium is a popular cut flower that is highly favored by consumers due to its snowy white color and strong fragrance, which originates from the release of monoterpenes.
Yun-Yao Yang +10 more
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Quality by design approach with design of experiment for sample preparation techniques
Advances in Sample Preparation, 2023 The quality by design (QbD) based approach has begun to be embedded in various method development. Studies show that with the design of experiment tool, the analysis process has become more efficient, faster, and easier.
Saniye Özcan +2 more
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Quality by Design for enabling RNA platform production processes.
Trends in Biotechnology, 2022 RNA-based products have emerged as one of the most promising and strategic technologies for global vaccination, infectious disease control, and future therapy development. The assessment of critical quality attributes (CQAs), product-process interactions,
Simon Daniel +3 more
semanticscholar +1 more source
Frontiers in Bioengineering and Biotechnology, 2021 RNA interference (RNAi) has an unprecedented potential as a therapeutic strategy for reversibly silencing the expression of any gene. Therapeutic delivery of the RNAi mediator, i.e., small interfering RNA (siRNA), can be used to address diseases ...
Abhijeet Lokras +5 more
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