Results 51 to 60 of about 62,955,482 (158)
, 2023 The objective of the study was to apply the principles of analytical quality by design (AQbD) to the analytical method for the determination of the radiochemical purity (PQR) of the radiopharmaceutical sodium iodide 131I oral solution, by means of thin layer chromatography (TLC) with a Radio-TLC scanner, the same one that allows to evaluate the quality
Miguel Vasquez +6 more
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Background: Pharmaceutical analytical methods are very important for ensuring drug quality. However traditional methods often rely on trial and error. This can lead to methods that're not very robust or flexible. Analytical Quality by Design (AQbD) is an approach. It uses science-based principles for analytical methods.
Manish Kumar Barala +2 more
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, 2021 Os resultados analíticos são utilizados como base para tomadas de decisão da conformidade. Porém, devido à incerteza de medição (IM), é possível que um método analítico não apresente desempenho adequado para sua aplicação na avaliação da conformidade ...
Separovic, Luciana
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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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Analytical Quality by Design Method Development for Vaccine Characterization [Elektronisk resurs]
, 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.
Sänger van de Griend, Catharina, +4 more
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, 2023 Analytical method validation ensures that a method provides trustworthy information about a particular sample when applied in accordance with the predefined protocol. According to regulatory standards, the rheological characteristics of topically applied
Vitorino, Carla +7 more
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Journal of Medical pharmaceutical and allied sciences, 2021 The current analytical exploration illustrated developing a reversed-phase high-performance liquid chromatography (RP-HPLC) technique and consequent substantiation for analyzing lamotrigine (LAM) active pharmaceutical ingredient (API) using a Quality-by-design (QbD) approach (Central Composite Design), in bulk product as well as in the tablet ...
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Analytical quality by design (aqbd) approach for an hplc method development and valiadtion [PDF]
Magistrsko delo se osredotoča na razvoj in validacijo HPLC metode za določanje sorodnih substanc v raztopini klorheksidin diglukonata z uporabo pristopa Analytical Quality by Design (AQbD).
Pavlović, Marko
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, 2019 O guia Q8(R2) do guia ICH descreve Qualidade por Design (QbD) como \"uma abordagem sistemática para desenvolvimento farmacêutico que começa com objetivos predefinidos e enfatiza produto, entendimento e controle dos processos, baseado em dados científicos
Moreira, Camila dos Santos
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International Journal of Pharmaceutical Research and ApplicationsAnalytical Quality by Design (AQbD) applies Quality by Design principles to analytical method development, aiming to design methods that are robust, well-understood, and life cycle managed. Herbicide residue analysis (monitoring active compounds and metabolites in formulations, food, soil, and water) presents challenges of trace-level detection, matrix
Wafa T Wafa T +3 more
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