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Analytical Procedure Validation and the Quality by Design Paradigm [PDF]
Journal of Biopharmaceutical Statistics, 2014 Since the adoption of the ICH Q8 document concerning the development of pharmaceutical processes following a quality by design (QbD) approach, there have been many discussions on the opportunity for analytical procedure developments to follow a similar approach.
Rozet, Eric +5 more
openaire +3 more sources
Acta Pharmaceutica, 2020 A UPLC-MS method for the estimation of atazanavir sulfate was developed using the “analytical quality by design” approach. The critical chromatographic quality attributes identified were retention time, theoretical plates and peak tailing.
Saha Chandni +2 more
doaj +1 more source
General Recipe for Designing Photonic Crystal Cavities [PDF]
, 2005 We describe a general recipe for designing high-quality factor (Q) photonic crystal cavities with small mode volumes. We first derive a simple expression for out-of-plane losses in terms of the k-space distribution of the cavity mode.
Englund, Dirk +2 more
core +1 more source
Searching for improvement [PDF]
, 2006 Engineering design can be thought of as a search for the best solutions to engineering problems. To perform an effective search, one must distinguish between competing designs and establish a measure of design quality, or fitness.
Atherton, MA, Bates, RA
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Green 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
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Analysis of Compounded Pharmaceutical Products to Teach the Importance of Quality in an Applied Pharmaceutics Laboratory Course [PDF]
, 2014 Objective. To assess the effectiveness of a product-analysis laboratory exercise in teaching students the importance of quality in pharmaceutical compounding. Design.
Almoazen +9 more
core +2 more sources
Journal 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
Quality By Design: Approach to Analytical Method Validation
Sciences 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
Which Design and Biomaterial Factors Affect Clinical Wear Performance of Total Disc Replacements? A Systematic Review [PDF]
, 2014 Background Total disc replacement was clinically introduced to reduce pain and preserve segmental motion of the lumbar and cervical spine. Previous case studies have reported on the wear and adverse local tissue reactions around artificial prostheses ...
Alexander, Dominik D. +4 more
core +2 more sources
Talanta 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