Critical reviews in analytical chemistry最新文献

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Anti-diabetic Biologicals: Exploring the Role of Different Analytical Techniques. 抗糖尿病生物制剂:探讨不同分析技术的作用。
IF 4.2 2区 化学
Critical reviews in analytical chemistry Pub Date : 2025-03-15 DOI: 10.1080/10408347.2025.2472793
Zahid Yaseen, Mukesh Nandave, Lalit Sharma
{"title":"Anti-diabetic Biologicals: Exploring the Role of Different Analytical Techniques.","authors":"Zahid Yaseen, Mukesh Nandave, Lalit Sharma","doi":"10.1080/10408347.2025.2472793","DOIUrl":"https://doi.org/10.1080/10408347.2025.2472793","url":null,"abstract":"<p><p>Antidiabetic biologicals (ADBs) have revolutionized the treatment of diabetes mellitus, once considered incurable through conventional medicine. These biological products, derived from natural sources <i>via</i> extraction, semi-synthesis, or recombinant DNA technology, include insulin and its analogs, GLP-1 receptor agonists, amylin analogs, and the recently approved monoclonal antibody teplizumab. Regulatory authorities worldwide have established QC parameters outlined in pharmacopoeias, alongside analytical techniques to ensure their safety and efficacy. This review focuses on the analytical techniques used to assess QC parameters of ADBs, including chromatographic methods, spectroscopic techniques, capillary electrophoresis, immunoassays, and endotoxin testing. Key parameters such as identification, potency, purity, and impurity profiling are thoroughly examined. The paper provides a comprehensive and up-to-date compilation of QC requirements and methodologies, along with a detailed comparison of analytical techniques. In doing so, it highlights their advantages and limitations, offering valuable insights for researchers and regulatory professionals involved in selecting suitable methods for QC assessment and understanding the complexities of ADBs evaluation. Furthermore, the article discusses the paramount importance of QC and future perspectives, emphasizing the transition to advanced versions of current techniques driven by the need for efficiency and reliability in quality testing.</p>","PeriodicalId":10744,"journal":{"name":"Critical reviews in analytical chemistry","volume":" ","pages":"1-22"},"PeriodicalIF":4.2,"publicationDate":"2025-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143633803","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Metabolomics as a Tool for Unraveling the Impact of Enantioselectivity in Cellular Metabolism. 代谢组学作为揭示细胞代谢中对映体选择性影响的工具。
IF 4.2 2区 化学
Critical reviews in analytical chemistry Pub Date : 2025-03-04 DOI: 10.1080/10408347.2025.2468926
Ana Sofia Almeida, Paula Guedes de Pinho, Fernando Remião, Carla Fernandes
{"title":"Metabolomics as a Tool for Unraveling the Impact of Enantioselectivity in Cellular Metabolism.","authors":"Ana Sofia Almeida, Paula Guedes de Pinho, Fernando Remião, Carla Fernandes","doi":"10.1080/10408347.2025.2468926","DOIUrl":"https://doi.org/10.1080/10408347.2025.2468926","url":null,"abstract":"<p><p>Metabolomics is an emerging interdisciplinary field focused on the comprehensive analysis of all metabolites within biological samples, making it valuable for areas such as drug development, and environmental analysis. Many compounds, including pharmaceuticals and agrochemicals that have been extensively studied by metabolomics are chiral. The intrinsic chirality of biological targets can lead to a selective recognition of enantiomers resulting in distinct pharmacokinetic, pharmacodynamic and/or toxicological profiles (enantioselectivity). Given that metabolomics captures an instant snapshot of an organism's metabolic state, it serves as a powerful tool to investigate chiral compounds and understand enantioselective effects. Herein, a systematic compilation of scientific literature was performed and 48 enantioselectivity studies using metabolomics were selected. These studies revealed an increasing focus on chiral pesticides (77%), the use of animal models (59%), reliance on LC-MS techniques (52%), and predominantly untargeted approaches (83%). Enantioselective effects were described in most studies. This review describes significant advances in this emerging field and highlights the use of metabolomics to unravel the role of stereochemistry in cellular metabolism by the examination of enantiomer-specific metabolic effects. Furthermore, it elucidates enantioselectivity mechanism that can be further applied to other groups of chiral compounds.</p>","PeriodicalId":10744,"journal":{"name":"Critical reviews in analytical chemistry","volume":" ","pages":"1-21"},"PeriodicalIF":4.2,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143540469","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Recent Developments in Colorimetric and Fluorimetric Chemosensors for the Detection of Mn2+ Ions: A Review (2010-2024). 比色和荧光化学传感器检测Mn2+离子的最新进展:综述(2010-2024)。
IF 4.2 2区 化学
Critical reviews in analytical chemistry Pub Date : 2025-02-19 DOI: 10.1080/10408347.2025.2460091
Eid H Alosaimi
{"title":"Recent Developments in Colorimetric and Fluorimetric Chemosensors for the Detection of Mn<sup>2+</sup> Ions: A Review (2010-2024).","authors":"Eid H Alosaimi","doi":"10.1080/10408347.2025.2460091","DOIUrl":"https://doi.org/10.1080/10408347.2025.2460091","url":null,"abstract":"<p><p>Manganese is an essential metal ion involved in various biological and environmental processes, but its excess can lead to toxicity, particularly affecting the nervous system. Therefore, developing selective and sensitive detection methods for Mn<sup>2+</sup> ions is of paramount importance. Colorimetric and fluorimetric chemosensors have emerged as promising tools for the detection of Mn<sup>2+</sup> due to their simplicity, cost-effectiveness, and real-time monitoring capabilities. This review discusses recent advances in the colorimetric and fluorimetric chemosensors that exhibit distinct color or fluorescence changes upon interaction with Mn<sup>2+</sup> ions. The review explores different organic and nanomaterials, focusing on their mechanisms of sensing, sensitivity, selectivity, and practical applications in environmental monitoring, healthcare, and food safety. The article also provides insights into future research directions aimed at overcoming these challenges, improving chemosensor performance, and expanding the applicability of colorimetric and fluorimetric chemosensors for Mn<sup>2+</sup> detection in diverse real-world scenarios.</p>","PeriodicalId":10744,"journal":{"name":"Critical reviews in analytical chemistry","volume":" ","pages":"1-21"},"PeriodicalIF":4.2,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143448156","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Analytical Capabilities and Future Perspectives of Chemometrics in Omics for Food Microbial Investigation. 化学计量学在食品微生物组学研究中的分析能力及未来展望。
IF 4.2 2区 化学
Critical reviews in analytical chemistry Pub Date : 2025-02-13 DOI: 10.1080/10408347.2025.2463430
Feifei Sun, Yu Zhang, Chin Ping Tan, Ying Gu, Yuanfa Liu, Yong-Jiang Xu
{"title":"Analytical Capabilities and Future Perspectives of Chemometrics in Omics for Food Microbial Investigation.","authors":"Feifei Sun, Yu Zhang, Chin Ping Tan, Ying Gu, Yuanfa Liu, Yong-Jiang Xu","doi":"10.1080/10408347.2025.2463430","DOIUrl":"https://doi.org/10.1080/10408347.2025.2463430","url":null,"abstract":"<p><p>Microbiomes significantly impact food flavor, food quality and human health. The development of omics technologies has revolutionized our understanding of the microbiome, the generated complex datasets, as well as their processing and interpretation need to be taken seriously. Currently, chemometrics has shown huge potential in omics data analysis, which is crucial to reveal the functional attributes and mechanisms of microbiomes in food nutrition and safety. However, various chemometric tools have their own characteristics, selecting appropriate technologies and performing multiomics data fusion analysis to improve the precision and reliability of food microbial investigations is still a huge challenge. In this review, we summarized the omics technologies used in food microbiome studies, overviewed the principle and applicability of chemometrics in omics, and discussed the challenges and prospects of chemometrics. The urgent need for chemometrics is to integrate deep learning (DL) and artificial intelligence algorithms to enhance its analytical capabilities and prediction accuracy. We hope this review will provide valuable insights of the integration of multiomics and bioinformatics combined with various chemometric techniques in data analysis for food microbial investigation. In the future, chemometrics combined with modern technologies for multiomics data analysis will further deepen our understanding of food microbiology and improve food safety.</p>","PeriodicalId":10744,"journal":{"name":"Critical reviews in analytical chemistry","volume":" ","pages":"1-14"},"PeriodicalIF":4.2,"publicationDate":"2025-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143405296","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The Importance and Use of Polydopamine in Molecularly Imprinted Polymer-Based Electrochemical Sensor Design. 聚多巴胺在基于分子印迹聚合物的电化学传感器设计中的重要性和用途。
IF 4.2 2区 化学
Critical reviews in analytical chemistry Pub Date : 2025-02-11 DOI: 10.1080/10408347.2025.2463442
Goksu Ozcelikay-Akyıldız, S Irem Kaya, Seyda Nur Samanci, Sibel A Ozkan
{"title":"The Importance and Use of Polydopamine in Molecularly Imprinted Polymer-Based Electrochemical Sensor Design.","authors":"Goksu Ozcelikay-Akyıldız, S Irem Kaya, Seyda Nur Samanci, Sibel A Ozkan","doi":"10.1080/10408347.2025.2463442","DOIUrl":"https://doi.org/10.1080/10408347.2025.2463442","url":null,"abstract":"<p><p>Due to their natural biocompatibility, cost-effectiveness, and strong interfacial adhesion, biopolymers have highly favorable properties for electrochemical biosensors. Due to this endogenous catecholamine's versatile chemistry, dopamine's oxidation and self-polymerization have recently attracted considerable interest. Polydopamine (PDA)'s application to surface deposition, molecular imprinting, and electrochemistry is especially noteworthy. This review aims to propose the role of PDA in quantitative applications, evaluate the analytical performance, cost, reproducibility, and versatility of the methods developed, and evaluate standard (bio)analytical platforms. First, the parameters and methods that influence the polymerization of dopamine are discussed. Then, different functionalities of PDA and its recent applications for different biosensing purposes are reviewed to build bioanalytical platforms. The discussion concludes with emerging applications of PDA-integrated biosensor platforms. Finally, future perspectives for improved use of PDA in bioanalytical applications are discussed.</p>","PeriodicalId":10744,"journal":{"name":"Critical reviews in analytical chemistry","volume":" ","pages":"1-18"},"PeriodicalIF":4.2,"publicationDate":"2025-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143390239","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Review of Modern Spectrometric Techniques for Monitoring Cadmium in Water and Enhancing Public Health. 现代光谱技术监测水中镉与促进公众健康的综述。
IF 4.2 2区 化学
Critical reviews in analytical chemistry Pub Date : 2025-02-08 DOI: 10.1080/10408347.2025.2457391
B K Vinay, Sivaramakrishnan Ganesan, T R Suranjan, B M Vivek
{"title":"Review of Modern Spectrometric Techniques for Monitoring Cadmium in Water and Enhancing Public Health.","authors":"B K Vinay, Sivaramakrishnan Ganesan, T R Suranjan, B M Vivek","doi":"10.1080/10408347.2025.2457391","DOIUrl":"https://doi.org/10.1080/10408347.2025.2457391","url":null,"abstract":"<p><p>Cadmium (Cd) contamination in aquatic ecosystems poses significant threats to environmental and public health due to its high toxicity and persistence. Even at trace levels, Cd can cause severe health issues, including kidney damage, bone disorders, and an increased risk of cancer, making its detection and monitoring critical. This review focuses on spectrometry techniques for detecting and quantifying Cd in water, evaluating its sensitivity, specificity, and adaptability to diverse environmental conditions. It highlights advancements in modern technologies that enhance the precision, speed, and reliability of these methods while addressing limitations such as high costs and operational complexity. The review also emphasizes the importance of integrating innovative approaches to improve portability and accessibility for real-time monitoring in resource-limited settings. By providing insights into current challenges and potential solutions, this study aims to guide the development of more efficient detection systems that support effective environmental management and safeguard public health from the harmful effects of cadmium contamination.</p>","PeriodicalId":10744,"journal":{"name":"Critical reviews in analytical chemistry","volume":" ","pages":"1-22"},"PeriodicalIF":4.2,"publicationDate":"2025-02-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143373589","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Advances and Challenges in Molecularly Imprinted Electrochemical Sensors for Application in Environmental, Biomedicine, and Food Safety. 分子印迹电化学传感器在环境、生物医学和食品安全中的应用进展与挑战。
IF 4.2 2区 化学
Critical reviews in analytical chemistry Pub Date : 2025-02-06 DOI: 10.1080/10408347.2025.2460751
Rui Liu, Meiting Zhao, Xin Zhang, Chaojun Zhang, Binqiao Ren, Jing Ma
{"title":"Advances and Challenges in Molecularly Imprinted Electrochemical Sensors for Application in Environmental, Biomedicine, and Food Safety.","authors":"Rui Liu, Meiting Zhao, Xin Zhang, Chaojun Zhang, Binqiao Ren, Jing Ma","doi":"10.1080/10408347.2025.2460751","DOIUrl":"https://doi.org/10.1080/10408347.2025.2460751","url":null,"abstract":"<p><p>Molecularly imprinted electrochemical sensors (MIECSs) are a specialized class of sensors based on molecularly imprinted derivative materials (MIDPs), which have been extensively applied in environmental monitoring, biomedicine, and food safety, allowing for high selectivity and sensitivity in detecting target molecules. This review provides an in-depth exploration of the most innovative and successful nanomaterials employed for modifying imprinted polymers, highlighting their crucial role in enhancing sensor performance, including carbon-based nanomaterials, meal derivatives, magnetic nanomaterials, polymeric and composite nanomaterials. In addition to reviewing advances in derivative materials design, this article delves into the current challenges facing molecularly imprinted sensors, such as issues related to template removal, nonspecific binding, and fabrication reproducibility. These challenges limit the practical application of MIECSs, particularly in complex real-world environments. The review also discusses representative applications of these sensors, including environmental monitoring, biomedicine and food safety, which demonstrate their versatility and potential. Finally, the review outlines future research directions aimed at overcoming these challenges. This includes strategies for improving the stability and reusability of MIECSs, enhancing their selectivity and sensitivity, and developing novel imprinting techniques. By addressing these issues, researchers can pave the way for the next generation of electrochemical sensors, which will be more robust, reliable, and suitable for a wide range of industrial and clinical applications.</p>","PeriodicalId":10744,"journal":{"name":"Critical reviews in analytical chemistry","volume":" ","pages":"1-19"},"PeriodicalIF":4.2,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143254856","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A Systematic Review of Chromatographic Methods for the Analysis of Plastic Additives in Fisheries and Aquaculture Products. 渔业和水产养殖产品中塑料添加剂色谱分析方法综述
IF 4.2 2区 化学
Critical reviews in analytical chemistry Pub Date : 2025-02-06 DOI: 10.1080/10408347.2024.2444684
Esther Garrido Gamarro, Rosa Mª Garcinuño Martínez, Gema Paniagua González, Pilar Fernández Hernando
{"title":"A Systematic Review of Chromatographic Methods for the Analysis of Plastic Additives in Fisheries and Aquaculture Products.","authors":"Esther Garrido Gamarro, Rosa Mª Garcinuño Martínez, Gema Paniagua González, Pilar Fernández Hernando","doi":"10.1080/10408347.2024.2444684","DOIUrl":"https://doi.org/10.1080/10408347.2024.2444684","url":null,"abstract":"<p><p>Microplastic particles have been found in a variety of food commodities, and fisheries and aquaculture products seem to be one of the main contributors to the dietary exposure of microplastics, which are complex mixes of chemicals, containing polymers, plastics additivities, and environmental contaminants. The implications for food safety are not well understood. The lack of simple and efficient analytical techniques for the determination of microplastics as well as their additives in food are some of the challenges. To improve the understanding of the methods available for the determination of plastic additives, a systematic literature review was conducted focusing on methods to determine those plastic additives known for their possible endocrine disruption and/or carcinogenic activity, such as bisphenol A (BPA), bisphenol F (BPF), bisphenol S (BPS), 4- nonylphenol (NP-4), nonylphenol (NP), diethyl phthalate (DEP), di-n-butyl phthalate (DBP), di(2-ethylhexyl)phthalate (DEHP), and polybrominated diphenyl ether (PBDE) in fisheries and aquaculture products. The review aimed to identify the most common extraction and determination methods used for these analytes and assess their efficiency. The findings of this review shed light on the current state of analytical methodologies in this field and provide insights that could inform and guide further research.</p>","PeriodicalId":10744,"journal":{"name":"Critical reviews in analytical chemistry","volume":" ","pages":"1-23"},"PeriodicalIF":4.2,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143364229","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Design Strategies and Analytical Performance of Dansyl Fluorophore-Based Fluorescent Sensors for Mercury Ion (Hg2+) Detection in Water. 基于丹酚荧光团的水中汞离子(Hg2+)荧光传感器设计策略及分析性能
IF 4.2 2区 化学
Critical reviews in analytical chemistry Pub Date : 2025-02-06 DOI: 10.1080/10408347.2024.2449532
Imran Muhammad, Tie-Zhen Ren, Rong Han, Xuejun Zhang, Khan Dawood, Adnan Shahzad
{"title":"Design Strategies and Analytical Performance of Dansyl Fluorophore-Based Fluorescent Sensors for Mercury Ion (Hg<sup>2+</sup>) Detection in Water.","authors":"Imran Muhammad, Tie-Zhen Ren, Rong Han, Xuejun Zhang, Khan Dawood, Adnan Shahzad","doi":"10.1080/10408347.2024.2449532","DOIUrl":"https://doi.org/10.1080/10408347.2024.2449532","url":null,"abstract":"<p><p>Recent years have seen a growing focus on the sensing of heavy metal cations in environmental samples, as we seek to promote a more sustainable environment. Mercury ion (Hg<sup>2+</sup>) is a heavy metal cation that has received significant attention in recent years due to its toxic nature to the ecology system. Exploring an efficient testing device to trace the content of Hg<sup>2+</sup> is of great importance. Dansyl chloride (DNS-Cl)-based sensors, with their unique recognition unit, have emerged as highly effective optical chemosensors for the sensing of Hg<sup>2+</sup>. These probes produce a fluorescent change in the either visible or ultraviolet range, as well as in an electronic and fluorometric spectrum, serving as a detection signal. These sensors are inexpensive, robust, eco-friendly, sensitive, and selective to Hg<sup>2+</sup>, making them a focus of attention for analytical and environmental laboratories. This review explores the applications of DNS-Cl derivatives in optical sensing for the detection of Hg<sup>2+</sup>, emphasizing the potential of sensors based on DNS-Cl in the sensing of Hg<sup>2+</sup>. The review assesses the advancements achieved in the field of fluorescent sensors utilizing DNS-Cl as a recognition unit. Notably, it underscores that the majority of these fluorophores have exhibited a high level of effectiveness in detection of Hg<sup>2+</sup>.</p>","PeriodicalId":10744,"journal":{"name":"Critical reviews in analytical chemistry","volume":" ","pages":"1-15"},"PeriodicalIF":4.2,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143364235","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Analytical Methodologies for Anti-Infective Orphan Drugs: A Comprehensive Review of FDA Approvals (2013-2023) Part 1. 抗感染孤儿药的分析方法:FDA批准的全面审查(2013-2023)第1部分。
IF 4.2 2区 化学
Critical reviews in analytical chemistry Pub Date : 2025-02-03 DOI: 10.1080/10408347.2025.2459721
Shimaa E Abdel Aziz, Heba E El-Nakib, Julia Schaletzky, Nermin S Ahmed
{"title":"Analytical Methodologies for Anti-Infective Orphan Drugs: A Comprehensive Review of FDA Approvals (2013-2023) Part 1.","authors":"Shimaa E Abdel Aziz, Heba E El-Nakib, Julia Schaletzky, Nermin S Ahmed","doi":"10.1080/10408347.2025.2459721","DOIUrl":"https://doi.org/10.1080/10408347.2025.2459721","url":null,"abstract":"<p><p>Most orphan diseases, which affect small patient populations, are chronic, incurable and often lead to early death. Due to small market size, orphan drugs developed to address these diseases receive little attention from the pharmaceutical industry. This lack of interest also applies to the development of analytical methods, which are crucial for drug analysis and quality control. Analysis of orphan drugs faces challenges, including a lack of reference standard and an inadequate number of samples for testing. In addition, constant adjustment of analytical techniques is demanded due to the lengthy development process. Financial constraints further hinder the advancement of analytical techniques since orphan drugs represents a narrow niche market and the pharmaceutical industry often focuses on research with greater impact, causing orphan drugs to be deprioritized. This review summarizes the analytical methods developed for US FDA-approved anti-infective orphan drugs (except antivirals) in the period between 2013 to 2023, covering in depth small molecules and broadly biologics in numerous dosage forms and biological samples. It covers the most common reported analytical methods, such as liquid chromatography, TLC, spectroscopy, and electrochemical analysis. This review highlights the crucial need for the continuous development of new analytical techniques to support the development and quality control of orphan drugs.</p>","PeriodicalId":10744,"journal":{"name":"Critical reviews in analytical chemistry","volume":" ","pages":"1-26"},"PeriodicalIF":4.2,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143078852","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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