Quality‐by‐design (QbD) is defined as a systematic approach to design and develop a product/service based on sound science and quality risk management. It is already frequently applied in the pharmaceutical industry mainly in the development of pharmaceutical products and analytical methods but is not well established in the setup of facilities like ...
Sultan Suleman +9 more
wiley +1 more source
Abstract The aim of this work was to develop a supercritical fluid chromatographic method to study the applicability of this emerging technique to cannabinoid analysis and showcase its advantages. During method development, the authors focused on nine phyto‐cannabinoids to assess the selectivity needed to potentially perform the quantitation of each ...
Riccardo Deidda +7 more
wiley +1 more source
Quality by Design Approach for an Orally Disintegrating Tablet Analytical Method Validation [PDF]
Quality by Design (QbD) is well established in the pharmaceutical industry for pharmaceutical development and manufacturing processes. The knowledge obtained during development may support the establishment of a design space and determines suitable ...
B. Yaman, A. Turkyilmaz Yaman +3 more
core +1 more source
Green RP-UPLC Method for Simultaneous Determination of Cyclopentolate and Organic Impurities Using DoE and Sustainability Metrics. [PDF]
A significant improvement in sustainability and efficiency is achievable through green and white chemistry. As part of this study, sustainability assessment tools were used to assess the environmental impact and practicality of an innovative, straightforward RP‐UPLC method to analyze cyclopentolate (CLO) and its organic impurities simultaneously in ...
Alsehli BR +5 more
europepmc +2 more sources
Experimental design in HPLC separation of pharmaceuticals [PDF]
Design of Experiments (DoE) is an indispensable tool in contemporary drug analysis as it simultaneously balances a number of chromatographic parameters to ensure optimal separation in High Pressure Liquid Chromatography (HPLC).
Stojanović Jevrem +5 more
doaj +1 more source
IMPLEMENTING OF ANALYTICAL QUALITY BY DESIGN FOR HIGH QUALITY PHARMACEUTICAL PRODUCTS [PDF]
The quality in the pharmaceutical industry has become a very important topic. Pharmaceutical industry has been emerging rapidly for the last decade by focusing on product Quality, Safety, and Efficacy.
P. Abhinandana1.2*, Ramarao Nadendla2
core +1 more source
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.
Jesús Alberto Afonso Urich +5 more
doaj +1 more source
Analytical Quality by Design Method Development for Vaccine Characterization [PDF]
Vaccines that are safe, efficacious, and can be rapidly developed are needed to prevent and to react to emerging global infectious disease threats such as influenza, Polio, and Coronavirus diseases.
Geurink, Lars
core
Analytical quality by design-based RP-HPLC method for quantification of pioglitazone and candesartan cilexetil in bilayer tablet and its forced degradation studies [PDF]
Aim: The current project involves developing an RP-HPLC method for simultaneous quantification of Candesartan Cilexetil and Pioglitazone based on analytical quality by design (AQbD).
Hephzibah Kola +1 more
doaj +3 more sources
Development of a colorimetric method for determination of neomycin sulphate using the concepts of quality by analytical design (AQbD) [PDF]
Para efetivamente tratar uma infecção, é necessário que o antibiótico possua atividade antimicrobiana adequada e seja capaz de inibir o crescimento do microrganismo patogênico.
Patricia Cristina de Santana +1 more
core +1 more source

