The pharmaceutical industry has increasingly adopted science- and risk-based approaches to ensure the quality, safety, and efficacy of pharmaceutical products. One of the most widely implemented strategies is Quality by Design (QbD), which emphasises systematic product and process understanding during drug development.
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Analytical Quality by Design-Assisted HPLC Method for Quantification of Canagliflozin and Stability Studies. [PDF]
ACS Omega, 2023 Azhakesan A, Kuppusamy S.
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Implementation of the QbD Approach to the Analytical Method Development and Validation for the Estimation of the Treprostinil Injection Dosage Form by RP-HPLC. [PDF]
ACS OmegaAlluri NR +3 more
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Sustainable Amide-Based Magnetic Dispersive Microextraction with an AQbD-Assisted Analytical Method to Detect Olanzapine from Milk-Based Food Matrices on Infusion Followed by a Green and White Assessment-Based Comparative Study. [PDF]
ACS OmegaSundara Moorthy R +4 more
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Quality by design (QbD) based development and validation of RP-HPLC method for buserelin acetate in polymeric nanoparticles: Release study. [PDF]
HeliyonTambare RS +4 more
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AQbD-enhanced green RP-UPLC-PDA methodology for quantification and forced degradation studies for omeprazole, amoxicillin, and rifabutin. [PDF]
BMC ChemBaffinsha SPA +2 more
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Review on - Analytical Quality by Design (AQbD) A Novel Approach for Method Development
Analytical Quality by Design (AQbD) is a systematic, science- and risk-based approach for analytical method development that ensures robustness, reliability, and lifecycle management. Unlike traditional trial-and-error methods, AQbD focuses on predefined objectives, comprehensive method understanding, and statistical evaluation of method variables ...
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A Review on: Optimizing Analytical Methods Through AQbD
Research in Medical & Engineering Sciencesopenaire +1 more source
Novel, Rapid, and Simple Isocratic UPLC-UV Method for Estimating Nitrate and Nitrite Contents in Environmental Water Samples Using an Analytical Quality by Design Approach. [PDF]
ACS OmegaGollapudi PK, Gollapudi KK, Padmaja DN.
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Objective: The main objective of this study was to develop a reliable and robust AQbD complient chaotropic chromatography method suitable for quality control of ziprasidone (ZPS) and its five impurities in capsules. Methods: The influence of Critical Method Parameters, CMPs (initial and final methanol content in the mobile phase, gradient duration) on ...
Rmandić, Milena +6 more
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