Results 1 to 10 of about 329 (162)

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.
Young Pyo Jang, Geonha Park
exaly   +6 more sources

AQbD Approach Applied to NIR in a Complex Topical Formulation: Bifonazole as Case Study [PDF]

Pharmaceutics
Background: A key challenge in modern pharmaceutical research is developing predictive models for drug formulation behavior. Since permeability is closely linked to molecular properties, considering a broad of characteristics is essential for building reliable predictive tools.
V Moura, Alberto Pais, Lucas Chiarentin   +2 more
exaly   +5 more sources

A Practical Approach to Implementing ICH Q14: Tools for Analytical Quality by Design in Capillary Electrophoresis Method Development. [PDF]

Electrophoresis
ABSTRACT The ICH Q14 guideline introduces a structured framework for analytical method development based on Analytical Quality by Design (AQbD) principles, aiming to ensure robust, reliable, and fit‐for‐purpose methods throughout the product lifecycle.
Tricht EV, Sänger-van de Griend CE.
europepmc   +2 more sources

Integrating analytical quality by design into bioanalytical method development: an HPLC-FLD method for quantification of alectinib in biological matrix [PDF]

BMC Chemistry
This 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, Nahyun Koo, Min Ju Kim, Kyeong-Ryoon Lee, Yoon-Jee Chae   +4 more
doaj   +2 more sources

AQbD-novel strategy for analytical methods

Future Journal of Pharmaceutical Sciences
Background 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, Rutuja Kothrukar, Hemant Chikhale, Sreya Kosanam, Laxmikant Borse   +4 more
doaj   +2 more sources

Development and Validation of a Stability-Indicating UPLC Method for the Determination of Hexoprenaline in Injectable Dosage Form Using AQbD Principles

Molecules, 2021
A novel and efficient stability-indicating, reverse phase ultra-performance liquid chromatographic (UPLC®) analytical method was developed and validated for the determination of hexoprenaline in an injectable dosage form.
Amrit Paudel, Jesus Alberto Afonso Urich   +1 more
exaly   +3 more sources

Quality by Design‐Based Development of a Robust LC Method for Simultaneous Estimation of Process‐ and Degradation‐Related Impurities in Rifapentine Drug Product for the Treatment of Active and Latent Tuberculosis [PDF]

Biomed Chromatogr
ABSTRACT A precise, robust, and stability‐indicating liquid chromatographic (LC) method coupled with a photodiode array (PDA) detector was developed and validated for the quantitative estimation of rifapentine, an essential therapeutic agent for both active and latent tuberculosis (TB).
Korikana S, Battula S, Konduru N, Kurnool A, Vemuri D, Dantinapalli V.   +5 more
europepmc   +2 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

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
Phil Borman, Walkiria Schlindwein, Daniel Markl   +2 more
exaly   +3 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, Catarina Cardoso, Margarida Miranda, Carla Vitorino   +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]

Molecules
The 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, Américo Castro-Luna, Norma Julia Ramos-Cevallos, Donald Ramos-Perfecto, Mario Alcarraz-Curi, Jacqueline Segura-Vasquez, Danny Cáceres-Antaurco   +6 more
doaj   +2 more sources