Risk‐based approach for method development in pharmaceutical quality control context: A critical review
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Summary
The AQbD workflow and its application in the development of methods to be used for pharmaceutical quality control have been treated and discussed and the different development strategies have been showcased, highlighting their advantages and disadvantages, in order to give a useful overview.
- Type
- article
- Published
- 2018-11-01
- Cited by
- 119
- References
- 74
- OpenAlex
- https://openalex.org/W30145448
- Semantic Scholar
- https://api.semanticscholar.org/CorpusID:52092499
Keywords
Agriculture, Irrigated agriculture, Joint (building), Economics, Agricultural economics
References
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- Quality by Design approach in the development of hydrophilic interaction liquid chromatographic method for the analysis of iohexol and its impurities.
- Application of quality by design elements for the development and optimization of an analytical method for protamine sulfate.
Cited by
- Computer‐assisted UHPLC–MS method development and optimization for the determination of 24 antineoplastic drugs used in hospital pharmacy
- Analytical quality by design: Development and control strategy for a LC method to evaluate the cannabinoids content in cannabis olive oil extracts
- A QCM-based assay of drug content in Eudragit RS 100-based delivery systems.
- Principles of Analytical Quality by Design for the development of quality control methods in a pharmaceutical context
- Development and Optimization of Liquid Chromatography Analytical Methods by Using AQbD Principles: Overview and Recent Advances
- Optimized hydrolytic methods by response surface methodology to accurately estimate the phenols in cereal by HPLC-DAD: The case of millet.
- Quality by Design as a risk-based strategy in pharmaceutical analysis: Development of a liquid chromatography-tandem mass spectrometry method for the determination of nintedanib and its impurities.
- A review of bioanalytical methods for the therapeutic drug monitoring of β-lactam antibiotics in critically ill patients: Evaluation of the approaches used to develop and validate quality attributes.
- Efinaconazole: DoE-supported development and validation of a quantitative HPTLC method and its application for the assay of drugs in solution and microemulsion-based formulations
- Development and Validation of an in-line API Quantification Method Using AQbD Principles Based on UV-Vis Spectroscopy to Monitor and Optimise Continuous Hot Melt Extrusion Process
- Development of a method of analysis for profiling of the impurities in phenoxymethylpenicillin potassium based on the analytical quality by design concept combined with the degradation mechanism of penicillins.
- Green analytical methods for isosorbide dinitrate determination by UV spectrophotometry and stability indicating HPLC-PDA
- Rapid and efficient chiral method development for lamivudine and tenofovir disoproxil fumarate fixed dose combination using ultra-high performance supercritical fluid chromatography: A design of experiment approach.
- Development of a Stability-Indicating Analytical Method for Determination of Venetoclax Using AQbD Principles
- Development of a green HPLC method for the analysis of artesunate and amodiaquine impurities using Quality by Design.
- Sequential DoE approach for the multiproduct analysis of cholesterol-lowering drugs by ultra-high performance supercritical fluid chromatography.
- A methodology employing retention modeling for achieving control space in liquid chromatography method development using quality by design approach.
- The analysis of cannabinoids in cannabis samples by supercritical fluid chromatography and ultra‐high‐performance liquid chromatography: A comparison study
- Design of Experiment Centered Multivariate Optimization Strategy for RP-HPLC Method to Quantitate Retapamulin in Topical Cream and Microemulsion
- An appraisal of experimental designs: Application to enantioselective capillary electromigration techniques
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