Analytical Quality by Design (AQbD) Approach to the Development of Analytical Procedures for Medicinal Plants [PDF]
Plants, 2022 Scientific regulatory systems with suitable analytical methods for monitoring quality, safety, and efficacy are essential in medicinal plant drug discovery.
Geonha Park +4 more
doaj +4 more sources
New Trends in the Quality Control of Enantiomeric Drugs: Quality by Design-Compliant Development of Chiral Capillary Electrophoresis Methods [PDF]
Molecules, 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.
Serena Orlandini +6 more
doaj +5 more sources
AQbD-Based UPLC-ELSD Method for Quantifying Medium Chain Triglycerides in Labrafac™ WL 1349 for Nanoemulsion Applications [PDF]
MoleculesIn response to recent regulatory guidelines, including ICH (International Council for Harmonisation) Q2 (R2) and Q14, we developed a UPLC-ELSD method to quantify Medium-Chain Triglycerides (MCTs) in Labrafac™ WL 1349 for nanoemulsion applications.
Alessio Gaggero +5 more
doaj +4 more sources
Development and Validation of an in-line API Quantification Method Using AQbD Principles Based on UV-Vis Spectroscopy to Monitor and Optimise Continuous Hot Melt Extrusion Process [PDF]
Pharmaceutics, 2020 A key principle of developing a new medicine is that quality should be built in, with a thorough understanding of the product and the manufacturing process supported by appropriate process controls. Quality by design principles that have been established
Juan Almeida +5 more
doaj +4 more sources
Standardized neutralization antibody analytical procedure for clinical samples based on the AQbD concept [PDF]
Signal Transduction and Targeted Therapy, 2023 Jianyang Liu +9 more
doaj +4 more sources
Analytical Quality by Design-Compliant Development of a Cyclodextrin-Modified Micellar ElectroKinetic Chromatography Method for the Determination of Trimecaine and Its Impurities. [PDF]
Molecules, 2023 In 2022, the International Council for Harmonisation released draft guidelines Q2(R2) and Q14, intending to specify the development and validation activities that should be carried out during the lifespan of an analytical technique addressed to assess ...
Marzullo L +9 more
europepmc +6 more sources
Integrating analytical quality by design into bioanalytical method development: an HPLC-FLD method for quantification of alectinib in biological matrix [PDF]
BMC ChemistryThis study presents the development and validation of a fluorescence-based high-performance liquid chromatography (HPLC) method for the quantification of alectinib in rat plasma, with a focus on the application of Analytical Quality by Design (AQbD) to ...
Eun Ji Lee +4 more
doaj +2 more sources
AQbD-novel strategy for analytical methods
Future Journal of Pharmaceutical SciencesBackground Analytical Quality by Design (AQbD) has emerged as a pivotal paradigm in the realm of analytical chemistry, revolutionizing the approach to method development and validation. This innovative strategy integrates principles of Quality by Design (
Amruta Bairagi +4 more
doaj +2 more sources
Rheology of Complex Topical Formulations: An Analytical Quality by Design Approach to Method Optimization and Validation [PDF]
Pharmaceutics, 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
Lucas Chiarentin +3 more
doaj +2 more sources
Increasing Analytical Quality by Designing a Thin-Layer Chromatography Scanner Method for the Determination of the Radiochemical Purity of Radiopharmaceutical Sodium Iodide 131I Oral Solution [PDF]
MoleculesThe goal of this study was to apply the principles of analytical quality by design (AQbD) to the analytical method for determining the radiochemical purity (PQR) of the radiopharmaceutical sodium iodide 131I oral solution, utilizing thin-layer ...
Miguel Vasquez-Huaman +6 more
doaj +2 more sources