Results 21 to 30 of about 353,897 (252)

Design for Quality with an Analytical Approach.

open access: yesJournal of the Japan Society for Precision Engineering, 1996
This paper presents an analytical approach to the problem of designing a product in consideration of its quality, i.e. the design-for-quality problem. At the stage of product design, product's quality is evaluated with Taguchi's quality loss function, which can be regarded as a measure of the generalized quality cost of the product.
YAMASHINA, Hajime   +2 more
openaire   +2 more sources

Eco-friendly based stability-indicating RP-HPLC technique for the determination of escitalopram and etizolam by employing QbD approach

open access: yesGreen Chemistry Letters and Reviews, 2022
ESC (Escitalopram) and ETZ (Etizolam) are essential anti-anxiety medications. This research suggests employing a Green Analytical Quality by Design (AQbD) based HPLC technique to determine ESC and ETZ are environmentally friendly. According to literature,
Durga Devi Perumal   +2 more
doaj   +1 more source

Analytical quality by design assisted RP-HPLC method for quantifying atorvastatin with green analytical chemistry perspective

open access: yesJournal of Chromatography Open, 2022
Analytical Quality by design and greener solvent methods were applied to optimize the High-Performance Liquid Chromatographic method for assessing atorvastatin calcium in bulk and pharmaceutical dosage forms are highlighted in the present work.
K.S. Kokilambigai, K.S. Lakshmi
doaj   +1 more source

Isolation, identification, structural elucidation, and toxicity prediction using (Q)-SAR models of two degradants: AQbD-driven LC method to determine the Roxadustat impurities

open access: yesTalanta Open, 2023
: Roxadustat (RDT) is the first orally administrated HIF-prolyl hydroxylase inhibitor drug used to treat anemia caused by chronic kidney disease. Two unknown degradants were detected in photolytic and oxidative stress conditions during the forced ...
Srinivas Nakka   +4 more
doaj   +1 more source

Analytical Quality by Design, Life Cycle Management, and Method Control [PDF]

open access: yesThe AAPS Journal, 2022
AbstractAnalytical methods are utilized throughout the biopharmaceutical and vaccines industries to conduct research and development, and to help control manufacturing inputs and outputs. These analytical methods should continuously provide quality data to support decisions while managing the remaining of risk and uncertainty.
Thorsten Verch   +10 more
openaire   +2 more sources

Working within the Design Space: Do Our Static Process Characterization Methods Suffice?

open access: yesPharmaceutics, 2020
The Process Analytical Technology initiative and Quality by Design paradigm have led to changes in the guidelines and views of how to develop drug manufacturing processes.
Moritz von Stosch   +8 more
doaj   +1 more source

A Review on Quality by Design Approach in Analytical Methods

open access: yesJournal of Drug Delivery and Therapeutics, 2022
Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives for a product, process understanding, and process control based on knowledge and quality risk management. All conventional methods may fail to the intended purpose during method development and validation.
Krushna Jadhav   +5 more
openaire   +1 more source

Quality By Design: Approach to Analytical Method Validation

open access: yesSciences of Pharmacy, 2022
A pharmaceutical industry is highly regulated by a quality policy in its management. The principles of Quality by Design (QbD) must be applied to ensure the development of pragmatic and systematic methods while managing the risks associated with analytical methods.
Mayang Dewi   +3 more
openaire   +1 more source

European Standard Clinical Practice Guideline and EXPeRT Recommendations for the Diagnosis and Management of Gastroenteropancreatic Neuroendocrine Neoplasms in Children and Adolescents

open access: yesPediatric Blood &Cancer, EarlyView.
ABSTRACT Pediatric gastroenteropancreatic neuroendocrine neoplasms (GEP‐NENs) are extremely rare and clinically heterogeneous. Management has largely been extrapolated from adult practice. This European Standard Clinical Practice Guideline (ESCP), developed by the EXPeRT network in collaboration with adult NEN experts, provides (adult) evidence ...
Michaela Kuhlen   +23 more
wiley   +1 more source

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

open access: yesMolecules, 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   +6 more
doaj   +1 more source

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