Results 71 to 80 of about 329 (162)
A Mini Overview of Analytical Quality by Design (AQbD)
A methodical, science- and risk-based approach to pharmaceutical development, Quality by Design (QbD) emphasizes incorporating quality into goods rather than depending just on end product testing. Through standards like ICH Q8 (Pharmaceutical Development), Q9 (Quality Risk Management), and Q10 (Pharmaceutical Quality System), regulatory bodies ...
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Systematic AQbD Approach to UPLC Method Development for Elacestrant and Pirtobrutinib
The evolution of pharmaceutical analysis has led to the integration of Analytical Quality by Design (AQbD). This strategic framework enhances the robustness, reliability, and regulatory compliance of analytical methods. This review focuses on the AQbD-based development and validation of a novel Ultra Performance Liquid Chromatography (UPLC) method for ...
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Quality by design in public healthcare: a rapid development framework for future pandemics
The growing number of pandemics and emergencies traversing the world in recent decades has illustrated the vulnerability of the conventional pharmaceutical development process and the necessity of an efficient, robust, and patient-driven pandemic-ready ...
Niranjan Panda +5 more
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AQbD guided optimization and validation of RP-HPLC method for Vildagliptin
Vildagliptin is an anti-diabetic drug used primarily for type 2 diabetes mellitus. One of themain reasons quality is lost in pharmaceuticals is the absence of appropriate and valid analyticaltechniques. This paper aims to describe the development and verification of a Quality byDesign (QbD) RP-HPLC method to determine Vildagliptin in bulk and tablet ...
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Analytical Quality by Design (AQbD): Principles, Tools and Case Studies
Quality by Design is a systematic approach used in pharmaceutical development that builds product quality into the formulation and manufacturing processes from the outset. Although its adoption is increasing within the generic drug industry, many professionals are still not deeply familiar with its principles or terminology.
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The study presents the development of a novel, sustainable, and analytical quality by design (AQbD) driven RP-HPLC method to simultaneously identify disodium edetate in eye drops and its degradation products.
Alanazi Tahani Y. A. +5 more
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Risk management should run through the entire process of method development, utilization, and maintenance. Based on the analytical quality by design (AQbD) concept, various integrated risk management techniques were used in this study to develop an ...
Mintong Zhao +5 more
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An accurate, precise, robust, and green RP-HPLC method was developed for assessment of three antiviral medications, namely Abacavir (ABA), Lamivudine (LAMI), and Zidovudine (ZIDO) in combined pharmaceutical dosage form by Analytical Quality by Design ...
Divyesh Vanparia +2 more
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The combination of Glycopyrronium, Fluticasone, and Vilanterol is utilized to manage chronic obstructive pulmonary disease (COPD) and mitigate asthma symptoms.
Anitha L, Durga Prasad Beda
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