ANALYTICAL QUALITY BY DESIGN (AQBD): CURRENT ADVANCES AND FUTURE PERSPECTIVES
Analytical methods play a vital role in pharmaceutical development, quality control, stability testing, and regulatory decision-making, as the reliability of drug product identity, strength, purity, safety, and stability depends on the quality of analytical data generated.
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Quality by design in public healthcare: a rapid development framework for future pandemics. [PDF]
Panda N +5 more
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Modern Optimization Strategies in High-Performance Liquid Chromatography Analysis. [PDF]
Elagamy SH, Elattar RH.
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Desenvolvimento de Métodos Analíticos com Base na Abordagem Quality by Design (AQBD)
Tese de Doutoramento em Ciências Farmacêuticas apresentada à Faculdade de FarmáciaInitially introduced by the Food and Drug Administration (FDA) and later incorporated into the ICH Q8(R2) guidelines by the International Council on Harmonization (ICH ...
Chiarentin, Lucas
core
Analytical Quality-by-Design-Based Development of an ELISA for <i>In Vitro</i> Assessment of Human Tetanus Immunoglobulin Potency. [PDF]
Son M +7 more
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AQbD-Guided Chiral HPLC for Enantiomeric Impurity Analysis of Suzetrigine. [PDF]
Alhunayhin SMN +6 more
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AQbD-Based Development and Optimization of a Stability-Indicating RP-HPLC Method for Imeglimin With Integration of Lean Six Sigma Principles. [PDF]
Bhusari VK, Ghorpade S, Sethy K.
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A Quality by Design alkalmazása a gyógyszerkészítmények fejlesztése során
A diplomamunka a gyógyszerek fejlesztésének, és gyártásának új modelljével, a Quality by Design-al foglalkozik. Bemutatja a még jelenleg alkalmazott QbT modellt, és összehasonlítja ezzel az új modellel. Részletesen ismerteti a QbD elemeit, és előnyeit. A
Biró, Lajos
core
AQbD-based development and validation of an HPLC-PDA method for simultaneous determination of sibutramine, desmethylsibutramine, and didesmethylsibutramine in herbal weight-loss supplements. [PDF]
Minh DTC +5 more
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