Results 21 to 30 of about 62,955,482 (158)
Analytical Quality by Design Approach to Test Method Development and Validation in Drug Substance Manufacturing [PDF]
, 2015 Pharmaceutical industry has been emerging rapidly for the last decade by focusing on product Quality, Safety, and Efficacy. Pharmaceutical firms increased the number of product development by using scientific tools such as QbD (Quality by Design) and PAT
Useni Reddy Mallu +2 more
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IMPLEMENTING OF ANALYTICAL QUALITY BY DESIGN FOR HIGH QUALITY PHARMACEUTICAL PRODUCTS [PDF]
, 2017 The quality in the pharmaceutical industry has become a very important topic. Pharmaceutical industry has been emerging rapidly for the last decade by focusing on product Quality, Safety, and Efficacy.
P. Abhinandana1.2*, Ramarao Nadendla2
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Analytical Quality by Design Method Development for Vaccine Characterization
, 2022 Vaccines that are safe, efficacious, and can be rapidly developed are needed to prevent and to react to emerging global infectious disease threats such as influenza, Polio, and Coronavirus diseases.
Geurink, Lars
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, 2023 Quality by Design (QbD) principles play an increasingly important role in pharmaceutical industry. Here, we used an analytical QbD (AQbD) approach to develop a capillary electrophoresis method under reducing conditions (rCE-SDS), with the aim of ...
Gritsch, Manuela +8 more
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, 2023 Introduction: The pharmaceutical sector is constantly evolving and is highly regulated with rules to ensure efficacy, safety and quality of medicines. Quality by Design (QbD) is a systematic approach to pharmaceutical development, grounded in scientific ...
Dibo do Nascimento, Diogo +5 more
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Expediting Disulfiram Assays through a Systematic Analytical Quality by Design Approach
, 2021 An Analytical Quality by Design (AQbD) approach is presented, aiming at the development and validation of an HPLC method for the quantification of disulfiram and copper diethyldithiocarbamate in lipid nanoparticles.
Vitorino, Carla +11 more
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, 2022 International audienceQuality-by-Design (QbD) guidance is a risk-based and proactive approach to drug development proposed in the mid 2000s and now widely used in the pharmaceutical field in compliance with the ICH Q8-Q11 guidelines.
Borgos, Sven +4 more
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SEPARATION SCIENCE PLUS, Volume 9, Issue 7, July 2026.ABSTRACT Itraconazole is a triazole antifungal agent used to treat a broad spectrum of systemic fungal infections. An accurate and efficient reversed phase chromatographic method was developed in accordance with the criteria of Green Analytical Chemistry and validated for the quantification of itraconazole in bulk and pharmaceutical dosage formulations
Tristan John Harakraj +3 more
wiley +1 more source
, 2022 Capillary electrophoresis (CE) is a potent method for analyzing chiral substances and is commonly used in the enantioseparation and chiral purity control of pharmaceuticals from different matrices.
Gotti, Roberto +13 more
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Journal of Pharmaceutical and Biopharmaceutical ResearchUsing advanced scientific and risk-based approaches for analytical methods offers significant benefits. Quality by Design (QbD) is a systematic framework that emphasizes understanding and controlling both product and process elements. Adhering to the principles outlined in the ICH guidelines can considerably improve the quality of drug substances ...
Vivekanandan Kalaiselvan +3 more
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