CE‐SDS method development, validation, and best practice—An overview
Sign Up to like & getrecommendations! Published in 2019 at "ELECTROPHORESIS"
DOI: 10.1002/elps.201900094
Abstract: CE‐SDS has been implemented in the biopharmaceutical industry and is being used for the characterization of therapeutic proteins in most Biological License Applications currently submitted. An overview is presented on the separation mechanism, methodology, and… read more here.
Keywords: development validation; method development; overview;
Synthetic pharmaceutical peptides characterization by chromatography principles and method development.
Sign Up to like & getrecommendations! Published in 2022 at "Journal of separation science"
DOI: 10.1002/jssc.202101034
Abstract: As per United States Food and Drug Administration, any polymer/chain composed of 40 or fewer amino acids is called as a peptide, where more than 40 amino acids are considered as proteins. In many occasions… read more here.
Keywords: pharmaceutical peptides; characterization; chromatography; synthetic pharmaceutical ... See more keywords
Automated ion exchange chromatography screening combined with in silico multifactorial simulation for efficient method development and purification of biopharmaceutical targets
Sign Up to like & getrecommendations! Published in 2022 at "Analytical and Bioanalytical Chemistry"
DOI: 10.1007/s00216-022-03982-z
Abstract: Bioprocess development of increasingly challenging therapeutics and vaccines requires a commensurate level of analytical innovation to deliver critical assays across functional areas. Chromatography hyphenated to numerous choices of detection has undeniably been the preferred analytical… read more here.
Keywords: exchange; purification; chromatography; development ... See more keywords
Analytical Method Development Using Transmission Raman Spectroscopy for Pharmaceutical Assays and Compliance with Regulatory Guidelines—Part II: Practical Implementation Considerations
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DOI: 10.1007/s12247-018-9350-0
Abstract: Transmission Raman spectroscopy is a relatively new technique for quantitative analysis of pharmaceutical products, either during manufacturing or as a finished product test. As with any new analytical tool, several requirements need to be met… read more here.
Keywords: transmission raman; method development; development; spectroscopy ... See more keywords
Investigation of scale reduction in a laboratory bread-making procedure: Comparative analysis and method development
Sign Up to like & getrecommendations! Published in 2018 at "Journal of Cereal Science"
DOI: 10.1016/j.jcs.2017.11.009
Abstract: Abstract Baking trials of eleven Hungarian wheat varieties were performed on macro- and micro-scale. The aim of this work was to investigate the applicability of a micro-scale bread making method using 10 g flour/loaf compared to… read more here.
Keywords: method development; volume; micro scale; method ... See more keywords
Analysis of potential genotoxic impurities in rabeprazole active pharmaceutical ingredient via Liquid Chromatography‐tandem Mass Spectrometry, following quality‐by‐design principles for method development
Sign Up to like & getrecommendations! Published in 2018 at "Journal of Pharmaceutical and Biomedical Analysis"
DOI: 10.1016/j.jpba.2017.11.037
Abstract: Graphical abstract Figure. No caption available. HighlightsValidation of a novel LC–MS/MS method for quantitation of 2 PGIs in rabeprazole API.A D‐optimal experimental design was employed for method development.Both numerical and categorical factors were utilized.Quality‐by‐Design (QbD)… read more here.
Keywords: quality; method development; analysis; quality design ... See more keywords
Implementation of a generic liquid chromatographic method development workflow: Application to the analysis of phytocannabinoids and Cannabis sativa extracts
Sign Up to like & getrecommendations! Published in 2018 at "Journal of Pharmaceutical and Biomedical Analysis"
DOI: 10.1016/j.jpba.2018.03.059
Abstract: HIGHLIGHTSA generic RPLC method development workflow was proposed.Screening, optimization, virtual refinement and virtual robustness testing were done.This workflow was applied to phytocannabinoids and Cannabis sativa extracts.This whole procedure takes only around 4days of work. ABSTRACT… read more here.
Keywords: method development; phytocannabinoids cannabis; development workflow; cannabis sativa ... See more keywords
SFC for chiral separations in bioanalysis
Sign Up to like & getrecommendations! Published in 2019 at "Journal of Pharmaceutical and Biomedical Analysis"
DOI: 10.1016/j.jpba.2018.08.061
Abstract: &NA; This review covers literature investigating methods for enantioselective chromatography using supercritical fluids as mobile phase constituents (SFC) in the field of bioanalysis. It provides an overview on method development and screening approaches published in… read more here.
Keywords: method development; bioanalysis; sfc; chiral separations ... See more keywords
Computer‐assisted UHPLC–MS method development and optimization for the determination of 24 antineoplastic drugs used in hospital pharmacy
Sign Up to like & getrecommendations! Published in 2019 at "Journal of Pharmaceutical and Biomedical Analysis"
DOI: 10.1016/j.jpba.2018.11.014
Abstract: HighlightsA generic UHPLC‐MS method development workflow was proposed for the analysis of antineoplastic drugs.Screening, optimization, virtual refinement and virtual robustness testing were done.Limited handling of toxic compounds was required to perform the whole method development.Complete… read more here.
Keywords: method development; method; uhplc method; optimization ... See more keywords
Bioanalytical method development and validation of corynantheidine, a kratom alkaloid, using UPLC-MS/MS, and its application to preclinical pharmacokinetic studies.
Sign Up to like & getrecommendations! Published in 2019 at "Journal of pharmaceutical and biomedical analysis"
DOI: 10.1016/j.jpba.2019.113019
Abstract: Corynantheidine, a minor alkaloid found in Mitragyna speciosa (Korth.) Havil, has been shown to bind to opioid receptors and act as a functional opioid antagonist, but its unique contribution to the overall properties of kratom… read more here.
Keywords: corynantheidine; method development; pharmacokinetic studies; analysis ... See more keywords
Generic approach in a gradient elution HPLC method development that enables troubleshooting free method transfer.
Sign Up to like & getrecommendations! Published in 2021 at "Journal of pharmaceutical and biomedical analysis"
DOI: 10.1016/j.jpba.2021.114367
Abstract: Nowadays, method development is strongly focused on reducing time needed for method development and execution. This subject specially concerns gradient elution methods regarding the usual need for troubleshooting assistance with uncertain outcome during the method… read more here.
Keywords: methodology; gradient elution; method development; method ... See more keywords