Results 41 to 50 of about 796 (185)
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 +2 more
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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 +5 more
doaj +1 more source
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 +2 more
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Developing health service delivery in a poor and marginalised community in North West Pakistan [PDF]
, 2018 Objective: To improve maternal health and reduce child mortality through developing health service delivery in a poor and marginalised community in North West Pakistan.
Bingley, Helen +5 more
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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 +2 more
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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 +5 more
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Analytical Method Validation: A Comprehensive Review of Current Practices [PDF]
Analytical method validation is a critical process in industries such as pharmaceuticals, food safety, biotechnology, and environmental monitoring. It guarantees reliability, reproducibility, and compliance with regulatory obligations. This review covers
Sachin S. Shinde, Dr. Preeti Khulbe
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Robust optimization of gradient RP HPLC method for simultaneous determination of ivabradine and its eleven related substances by AQbD approach [PDF]
, 2022 This paper is aimed at developing a gradient elution reversed-phase high-performance liquid chromatography (RP-HPLC) method for the separation of a complex mixture composed of ivabradine and its eleven impurities, in a reasonable timeframe.
Agbaba, Danica +5 more
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Chromatographic study of sitagliptin and ertugliflozin under quality-by-design paradigm
Brazilian Journal of Pharmaceutical Sciences, 2023 The present study entails the systematic development and validation of a stability-indicating RP-HPLC method for the analysis of sitagliptin and ertugliflozin in a fixed-dose combination.
Sunitha Gurrala +4 more
doaj +1 more source
A sigma model field theoretic realization of Hitchin's generalized complex geometry
, 2004 We present a sigma model field theoretic realization of Hitchin's generalized complex geometry, which recently has been shown to be relevant in compactifications of superstring theory with fluxes.
A. Kapustin +18 more
core +5 more sources