Results 41 to 50 of about 325 (160)

Quality‐by‐Design Principles Applied to the Establishment of a Pharmaceutical Quality Control Laboratory in a Resource‐Limited Setting: The Lab Water

International Journal of Analytical Chemistry, Volume 2022, Issue 1, 2022., 2022
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, Sileshi Belew, Dereje Kebebe, Markos Duguma, Henok Teshome, Gemmechu Hasen, Evelien Wynendaele, Luc Duchateau, Bart De Spiegeleer, Eladia M. Pena Mendez   +9 more
wiley   +1 more source

The analysis of cannabinoids in cannabis samples by supercritical fluid chromatography and ultra‐high‐performance liquid chromatography: A comparison study

Analytical Science Advances, Volume 2, Issue 1-2, Page 2-14, February 2021., 2021
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, Cédric Schelling, Jean‐Marc Roussel, Amandine Dispas, Charlotte De Bleye, Éric Ziemons, Philippe Hubert, Jean‐Luc Veuthey   +7 more
wiley   +1 more source

Four‐step approach to efficiently develop capillary gel electrophoresis methods for viral vaccine protein analysis

ELECTROPHORESIS, Volume 42, Issue 1-2, Page 10-18, January 2021., 2021
Abstract Vaccines against infectious diseases are urgently needed. Therefore, modern analytical method development should be as efficient as possible to speed up vaccine development. The objectives of the study were to identify critical method parameters (CMPs) and to establish a set of steps to efficiently develop and validate a CE‐SDS method for ...
Lars Geurink, Ewoud van Tricht, Justin Dudink, Bojana Pajic, Cari E. Sänger – van de Griend   +4 more
wiley   +1 more source

Green RP-UPLC Method for Simultaneous Determination of Cyclopentolate and Organic Impurities Using DoE and Sustainability Metrics. [PDF]

Int J Anal Chem
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, Alluhayb AH, Al-Khateeb LA, Saleh SM, Binsaleh AY, Mohamed MA.   +5 more
europepmc   +2 more sources

Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics

International Journal of Analytical Chemistry, 2015
Very recently, Food and Drug Administration (FDA) has approved a few new drug applications (NDA) with regulatory flexibility for quality by design (QbD) based analytical approach.
Ramalingam Peraman, Kalva Bhadraya, Yiragamreddy Padmanabha Reddy   +2 more
doaj   +1 more source

AQbD-Oriented UHPLC/MS/MS Method Development for Glycopeptides Assessment in Pharmaceutical Forms

Journal of Chromatographic Science, 2021
Abstract Vancomycin and teicoplanin are glycopeptide antibacterials that inhibit the bacteria cell wall synthesis showing activity against gram-positive bacteria. Development of the sensitive method is of great importance for quality control of these drugs that are fermentation products.
A, Stajić, J, Janković-Maksić, B, Jančić-Stojanović, M, Medenica   +3 more
openaire   +2 more sources

Expediting Disulfiram Assays through a Systematic Analytical Quality by Design Approach

Chemosensors, 2021
An Analytical Quality by Design (AQbD) approach is presented, aiming at the development and validation of an HPLC method for the quantification of disulfiram and copper diethyldithiocarbamate in lipid nanoparticles.
João Basso, Maria Luísa Ramos, Alberto Pais, Rui Vitorino, Ana Fortuna, Carla Vitorino   +5 more
doaj   +1 more source

Environmental benign RP-HPLC method for the simultaneous estimation of anti-hypertensive drugs using analytical quality by design

Green Chemistry Letters and Reviews, 2023
Green analytical procedures replace harmful organic modifiers with green solvents without affecting chromatographic performance, enabling industries and research laboratories to develop green analytical methods.
Naveenarani Dharuman, Karunanidhi Santhana Lakshmi, Manikandan Krishnan   +2 more
doaj   +1 more source

Analytical Quality by Design Approach to Test Method Development and Validation in Drug Substance Manufacturing

Journal of Chemistry, 2015
Pharmaceutical industry has been emerging rapidly for the last decade by focusing on product Quality, Safety, and Efficacy. Pharmaceutical firms increased the number of product development by using scientific tools such as QbD (Quality by Design) and PAT
N. V. V. S. S. Raman, Useni Reddy Mallu, Hanimi Reddy Bapatu   +2 more
doaj   +1 more source

Design and evaluation of amphotericin b and luliconazole nanoemulsions for targeted antifungal delivery

Journal of Applied Pharmaceutical Research
Background: Drugs like Amphotericin B and Luliconazole, which are poorly soluble in water and undergo significant first-pass metabolism, often show low bioavailability.
Pravin N. Kirdat, Meenakshi B. Patel
doaj   +1 more source