Results 31 to 40 of about 279 (161)

Sixteen capillary electrophoresis applications for viral vaccine analysis

ELECTROPHORESIS, Volume 43, Issue 9-10, Page 1068-1090, May 2022., 2022
Abstract A broad range of CE applications from our organization is reviewed to give a flavor of the use of CE within the field of vaccine analyses. Applicability of CE for viral vaccine characterization, and release and stability testing of seasonal influenza virosomal vaccines, universal subunit influenza vaccines, Sabin inactivated polio vaccines ...
Lars Geurink, Ewoud van Tricht, Debbie van der Burg, Gerard Scheppink, Bojana Pajic, Justin Dudink, Cari Sänger–van de Griend   +6 more
wiley   +1 more source

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

New Trends in the Quality Control of Enantiomeric Drugs: Quality by Design-Compliant Development of Chiral Capillary Electrophoresis Methods

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, Gabriel Hancu, Zoltán-István Szabó, Adriana Modroiu, Lajos-Attila Papp, Roberto Gotti, Sandra Furlanetto   +6 more
doaj   +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

Experimental design in HPLC separation of pharmaceuticals [PDF]

Arhiv za farmaciju, 2021
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, Krmar Jovana, Protić Ana, Svrkota Bojana, Đajić Nevena, Otašević Biljana   +5 more
doaj   +1 more source

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

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.
Jesús Alberto Afonso Urich, Viktoria Marko, Katharina Boehm, Raymar Andreína Lara García, Dalibor Jeremic, Amrit Paudel   +5 more
doaj   +1 more source

Software-assisted analytical Quality by Design for stability-indicating method development: integration of DoE and predictive retention modeling using MODDE® and DryLab® [PDF]

Makedonsko Farmacevtski Bilten
In modern pharmaceutical development, the increasing complexity of drug substances, formulations, and regulatory expectations has rendered traditional one-factor-at-a-time (OFAT) approaches to analytical method development inefficient and increasingly ...
Dino Karpicarov, Ivana Mitrevska, Blagica Manchevska, Paulina Apostolova, Jasmina Tonic Ribarska, Biljana Gjorgjeska   +5 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