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Development of Quality-By-Design Analytical Methods
Journal of Pharmaceutical Sciences, 2011Quality-by-design (QbD) is a systematic approach to drug development, which begins with predefined objectives, and uses science and risk management approaches to gain product and process understanding and ultimately process control. The concept of QbD can be extended to analytical methods.
Frederick G, Vogt, Alireza S, Kord
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A Complete Roadmap of Analytical Quality by Design in Various Analytical Techniques
Current Pharmaceutical Analysis, 2023Background: For the development of robust analytical methods, Analytical-Qualityby- Design (AQbD)-based testing methods have been found to be more suited than other one factorial approaches. By creating a Method Operable Design Space, this strategy selects the optimal method conditions using the appropriate Design of Experiments.
Mohana Krishnan Santhanam +3 more
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Quality by Design approaches to Analytical Method Development
Research Journal of Pharmacy and Technology, 2017The concept of QbD to the analytical method development is as known AQbD (Analytical Quality by design). It is an informal in the pharmaceutical industry to perform analytical quality by design (AQbD) in method development activity as a part of risk management, pharmaceutical development, and pharmaceutical quality system.
Vedantika Das +2 more
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Quality by Design Approch Based in Analytical Method Validation
Asian Journal of Pharmaceutical Analysis, 2023Quality by design is used to designing and developing a formulation and manufacturing process to ensure a predefined quality and this process to enhance capability of process and reduce product variability and defects by increasing product and process design understanding and control. According to guidelines of International conference on Harmonization,
Prerana Musale, S. D. Mankar
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Analytical development is considered as an integral part of the pharmaceutical product life-cycle, where establishment of an effective, cost-effective, robust, sensitive, and specific analytical methods are always required for analysis of drug(s), degradation product(s), and impurities in dosage forms. As analytical method development involves a series
O. S. Bilone +4 more
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O. S. Bilone +4 more
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Designing Quality: Quality by Design in Analytical Pharmaceutical Development
2016This study presents the development of a new RP-UPLC analytical method for the quality control of a pharmaceutical product, according to Quality by Design (QbD) guidelines. QbD is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding.
NOMPARI, LUCA +3 more
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Analytical Quality by Design: A Systematic Review
At various points throughout the life cycle of a pharmaceutical product, analytical procedures must be established. If these tasks are not appropriately simplified based on scientific knowledge and process understanding, it could result in an extremely expensive and time-consuming approach.openaire +1 more source
Quality by Design and Analytical Quality by Design for Pharmaceutical Development
Quality Target Product Profile (QTPP) is a concept that describes all the quality attributes (QA) of the product that can be optimized during the product development. Quality Control (QC) allows to assess the quality of the final product by means of the monitoring of the QAs and thus it is a key factor in pharmaceutical and biopharmaceutical ...S. Furlanetto +4 more
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Analytical quality by design for capillary electrophoresis
2021Mohammed Asadullah Jahangir +4 more
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