Results 151 to 160 of about 1,590,893 (188)

Quality by Design Compliant Analytical Method Validation

Analytical Chemistry, 2011
The concept of quality by design (QbD) has recently been adopted for the development of pharmaceutical processes to ensure a predefined product quality. Focus on applying the QbD concept to analytical methods has increased as it is fully integrated within pharmaceutical processes and especially in the process control strategy. In addition, there is the
Rozet, Eric, Ziemons, Eric, Marini Djang'Eing'A, Roland, Boulanger, Bruno, Hubert, Philippe   +4 more
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ANALYTICAL QUALITY BY DESIGN

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, P. O. Bilone, A. P. Dewani, N. I. Kochar, A. V. Chandewar P   +4 more
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A Decision-Analytic Method for Competitive Design for Quality

18th Design Automation Conference: Volume 1 — Optimum Design, Manufacturing Processes, and Concurrent Engineering, 1992
Abstract We consider the design issues of characterizing and appropriately choosing the quality of a product for maximum customer satisfaction and maximum corporate profit. We assume that the basic design configuration of a product is determined and that the designer must select the product quality by imposing statistical tolerances ...
Hubert Vasseur, Thomas R. Kurfess, Jonathan Cagan   +2 more
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Quality by Design approaches to Analytical Method Development

Research Journal of Pharmacy and Technology, 2017
The 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, Bhushan Bhairav, R. B. Saudagar   +2 more
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Designing Quality: Quality by Design in Analytical Pharmaceutical Development

2016
This 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, ORLANDINI, SERENA, FURLANETTO, SANDRA, Carinci, V.   +3 more
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Design Quality Analytics of Traceability Enablement in Service-Oriented Solution Design Environment

2009 IEEE International Conference on Web Services, 2009
This paper provides an artifact-pattern-matchingframework and mathematical model to analyze thedynamic behaviors of the SOA solution design in modeldrivenfashion and provide recommendations for optimalsolution pattern enablement for solution artifacts.
Liang-Jie Zhang, Zhi-Hong Mao, Nianjun Zhou   +2 more
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Introduction to analytical quality by design

2021
Sarwar Beg, Jamshed Haneef, Mahfoozur Rahman, Ramalingam Peraman, Mohamad Taleuzzaman, Waleed H. Almalki   +5 more
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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, S. Orlandini, B. Pasquini, R. Gotti, A. Guiraldelli   +4 more
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A Review on Advancement in Analytical Quality by Design (AQbD)

Current Analytical Chemistry
Analytical Quality by Design (AQbD) represents a transformative methodology in pharmaceutical development, anchored in a systematic, risk-based, and data-driven framework. This approach optimizes analytical methods, fostering heightened product quality, efficient regulatory compliance, and informed decision ...
Ankit Kumar Singh, Yogita Vashitha, Ashita Jain, Ghanshyam Das Gupta, Sant Kumar Verma   +4 more
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Analytical Quality by Design and Quality Control of drugs: from Quality Target Product Profile to the Analytical Target Profile

2023
Quality Control (QC) plays a pivotal role in the pharmaceutical and biopharmaceutical development, as it is essential for assessing product's quality, safety and efficacy. It involves a series of analytical procedures designed and validated to inspect and monitor the product’s quality attributes.
S. Furlanetto, S. Orlandini, G. Pieraccini, R. Gotti, G. Massolini, C. Temporini, F. Luciani, F. Marino, A. Ascione, A. Guiraldelli, N. Rautela   +10 more
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