Results 1 to 10 of about 833 (196)

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, Young-Pyo Jang
exaly   +6 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.
Orlandini S, Hancu G, Szabó ZI, Modroiu A, Papp LA, Gotti R, Furlanetto S.   +6 more
europepmc   +5 more sources

Development and validation of a novel isocratic RP-HPLC method using AQbD approach for the quantification of favipiravir [PDF]

European Journal of Pharmaceutical Sciences
Background/Objectives: In this study, the analytical quality by design (AQbD) approach was used to develop an eco-friendly reversed-phase high-performance liquid chromatography (RP–HPLC) method to identify and quantify favipiravir (FAV).
Bence Sipos
exaly   +5 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, Mariana Bezerra, Daniel Markl, Andreas Berghaus, Phil Borman, Walkiria Schlindwein   +5 more
doaj   +4 more sources

Standardized neutralization antibody analytical procedure for clinical samples based on the AQbD concept. [PDF]

Signal Transduct Target Ther, 2023
Liu J, Bai Y, Liu M, Tan D, Li J, Wang Z, Liang Z, Xu M, Wang J, Mao Q.   +9 more
europepmc   +4 more sources

Analytical Quality by Design (AQbD) Approach to the Development of In Vitro Release Test for Topical Hydrogel [PDF]

Pharmaceutics, 2022
The aim of our study was to adapt the analytical quality by design (AQbD) approach to design an effective in vitro release test method using USP apparatus IV with a semi-solid adapter (SSA) for diclofenac sodium hydrogel. The analytical target profile (ATP) of the in vitro release test and ultra-high-performance liquid chromatography were defined; the ...
Berkó Szilvia, Budai-Szűcs Mária, Csányi Erzsébet, Kovács Anita, Pannonhalminé Csóka Ildikó, Szoleczky Réka, Tonka-Nagy Péter   +6 more
core   +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

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.
Chiarentin L, Moura V, Pais AACC, Vitorino C.   +3 more
europepmc   +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, Gotti R, Orlandini S, Slavíčková P, Jireš J, Zapadlo M, Douša M, Nekvapilová P, Řezanka P, Furlanetto S.   +9 more
europepmc   +6 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