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Analytical quality by design guided white analytical chemistry driven green in the development of LC-ICP-MS method for arsenic speciation analysis in HEK-293 cells

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JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL technologies IN THE biomedical AND LIFE SCIENCES 2025年 1252卷 124474页

作者： Naresh, Pothuraju Roy, Salona Devnath Pawaskar, Prashant vilas Lokhande, Puja Shamrao Gajbhiye, Rahul Laxman Peraman, Ramalingam Natl Inst Pharmaceut Educ & Res NIPER Hajipur Dept Pharmaceut Anal Hajipur 844102 Bihar India Natl Inst Pharmaceut Educ & Res NIPER Dept Pharmacol & Toxicol Hajipur 844102 Bihar India Louisiana State Univ Biol & Agr Engn Dept Baton Rouge LA USA

An analytical quality by design-guided LC-ICP-MS method for simultaneous arsenic speciation analysis in HEK293 cells was optimized and validated. Initially, critical method variables (CMvs) were identified to achieve the targeted critical quality attribute (CQA) of the analytical target profile (ATP). Based on knowledge and risk assessments, formic acid (X1), citric acid (X2), and pH (X3) were studied for their effect on method responses such as resolutions (Y1, Y2) and retention time of As(v), As(III) and DMA (Y3, Y4, and Y5) using central composite design (CCD). ANOvA analysis indicated that variable interaction was significant in method responses with curvature effect on resolution (Y1 and Y2). The method operable design region (MODR) afforded a 0.1% formic acid, citric acid strength of 20-30 mM, and pH 5.6-6.8 as a robust region for the appropriate method performance. Hence, the final method was optimized on the ZORBAX RRHD SB-Aq column using a mobile phase consisting of 0.1% Formic acid: Citric acid (22.5 mM) (50:50 % v/v;pH 5.6). The optimized method eluted As (v), As(III), and DMA at 2.5 +/- 0.1, 2.7 +/- 0.1, and 3.1 +/- 0.1 min, respectively, with an acceptable resolution. The LOD of the method was 4.78, 3.39, 5.35 ppb respectively for As(v), As(III), and DMA whilst the linearity was established at 30-1000 ppb for all species with respective r2-value of 0.9967, 0.9996, and 0.9972, respectively. The % recovery (77.11-99.64 %) and precision (0.25-1.95 %) were acceptable. The method has proven robust for method variables. Notably, we conducted the Green-white analytical chemistry assessment for the developed method by three different assessment tools viz., AGREES, GAPI, and RGB of 12 algorithms. The developed method demonstrated robustness, environmental friendliness, and user-friendliness.

关键词： AQbD Arsenic speciation Central composite design HEK-293

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Epoxy resin phantoms emulating oxy and deoxyhemoglobin for applications in optical mammography 18

Epoxy resin phantoms emulating oxy and deoxyhemoglobin for a...

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2025 conference on design and quality for biomedical technologies

作者： Waks-Serraa, Maria v. veraa, Demian A. Carbonea, Nicolas A. Pardini, Pamela A. Garcia, Hector A. Pomaricoa, Juan A. Iriartea, Daniela I. Consejo Nacl Invest Cient & Tecn CIFICEN UNCPBA CICPBA Buenos Aires DF Argentina BIONIRS Arg SA Buenos Aires DF Argentina Univ Wisconsin Madison Dept Med Phys Madison WI 53706 USA

ISBN: (纸本)9781510683648;9781510683655

Near infrared spectroscopy (NIRS) is a valuable, inexpensive and noninvasive tool for complementary breast cancer diagnosis, however the performance of NIRS devices still need to be tested before implementation in clinical situations. The use of phantoms has proven to be a very powerful way to evaluate experimental approaches as well as to test possible diagnostics equipment. In this work we developed phantoms that can emulate either benign or malignant tumors and, in contrast to those constructed with biological chromophores, do not require specific storage, and are stable in time. We studied the feasibility of employing two artificial commercially available absorbents as a replacement for the oxygenated and deoxygenated hemoglobin present in breast tumors, a dye (ADS830WS) and an ink (Epson673). Tumor-like inclusions were made of epoxy resin containing these absorbents to emulate the absorption curves of both hemoglobin species to reproduce one type of benign and one type of malignant tumors: a fibradenoma and an adenocarcinoma. To evaluate the approach we performed CW transmittance imaging experiments, which were validated by Monte Carlo (MC) simulations. The results indicate that the constructed phantoms effectively replicate the desired targets. It was also possible to retrieve maps of concentrations of absorbents from the diffuse imaging experiments via the Modified Beer Lambert Law (MBLL). The reconstruction algorithm was able to discriminate between the two types of lesions mimicked in this study. In summary, we expect this work will contribute to the development of more specific and accurate phantoms oriented to testing CW-NIRS devices for biomedical applications such as Optical Mammography.

关键词： Phantoms Hemoglobin Tumors Epoxy Resin Continuous Wave Near Infrared Spectroscopy Breast imaging

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design of experiment and machine learning inform on the 3D printing of for biomedical

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BIOMATERIALS ADvANCES 2023年 153卷 213533页

作者： Bozorg, Neda Madadian Leclercq, Mickael Lescot, Theophraste Bazin, Marc Gaudreault, Nicolas Dikpati, Amrita Fortin, Marc-Andre Droit, Arnaud Bertrand, Nicolas Univ Laval Fac Pharm Ctr Rech Materiaux Avances CERMA Quebec City PQ G1V 0A6 Canada Univ Laval Ctr Rech CHU Quebec Axe Endocrinol & Nephrol Quebec City PQ G1V 4G2 Canada Univ Laval Ctr Rech Materiaux Avances CERMA Dept Genie Mines Met & Mat Facultedes Sci & Genie Quebec City PQ G1V 0A6 Canada Univ Laval Ctr Rech CHU Quebec Axe Med Regneratrice Quebec City PQ G1V 4G2 Canada Univ Laval Ctr Rech CHU Quebec Axe Neurosci Quebec City PQ G1V 0A6 Canada Univ Laval Fac Med Dept Med Mol Quebec City PQ G1V 0A6 Canada Univ Laval Fac Pharm CHU Quebec Res Ctr 2705 Laurier BlvdT4-13 Quebec City PQ G1V 4G2 Canada

In the biomedical field, 3D printing has the potential to deliver on some of the promises of personalized therapy, notably by enabling point-of-care fabrication of medical devices, dosage forms and bioimplants. To achieve this full potential, a better understanding of the 3D printing processes is necessary, and non-destructive character-ization methods must be developed. This study proposes methodologies to optimize the 3D printing parameters for soft material extrusion. We hypothesize that combining image processing with design of experiment (DoE) analyses and machine learning could help obtaining useful information from a quality-by-design perspective. Herein, we investigated the impact of three critical process parameters (printing speed, printing pressure and infill percentage) on three critical quality attributes (gel weight, total surface area and heterogeneity) monitored with a non-destructive methodology. DoE and machine learning were combined to obtain information on the process. This work paves the way for a rational approach to optimize 3D printing parameters in the biomedical field.

关键词： 3D printing technology Personalized medication Image processing Statistical analysis Machine learning Pharmaceutical sciences

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Comparative fatigue performance of as-built vs etched Ti64 in TPMS-gyroid and stochastic structures fabricated via PBF-LB for biomedical applications

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RAPID PROTOTYPING JOURNAL 2024年第11期30卷 216-229页

作者： Araya-Calvo, Miguel Jarvenpaa, Antti Rautio, Timo Morales-Sanchez, Johan Enrique Guillen-Giron, Teodolito Tecnol Costa Rica Bioinspired Proc & Mat Res Grp Cartago Costa Rica Univ Oulu Kerttu Saalasti Inst Future Mfg Technol Res Grp Oulu Finland Tecnol Costa Rica Biol Dept Cartago Costa Rica

PurposeThis study compares the fatigue performance and biocompatibility of as-built and chemically etched Ti-6Al-4v alloys in TPMS-gyroid and stochastic structures fabricated via Powder Bed Fusion Laser Beam (PBF-LB). This study aims to understand how complex lattice structures and post-manufacturing treatment, particularly chemical etching, affect the mechanical properties, surface morphology, fatigue resistance and biocompatibility of these metamaterials for biomedical ***/methodology/approachSelective Laser Melting (SLM) technology was used to fabricate TPMS-gyroid and voronoi stochastic designs with three different relative densities (0.2, 0.3 and 0.4) in Ti-6Al-4v ELI alloy. The as-built samples underwent a chemical etching process to enhance surface quality. Mechanical characterization included static compression and dynamic fatigue testing, complemented by scanning electron microscopy (SEM) for surface and failure analysis. The biocompatibility of the samples was assessed through in-vitro cell viability assays using the Alamar Blue assay and cell proliferation *** etching significantly improves the surface morphology, mechanical properties and fatigue resistance of both TPMS-gyroid and stochastic structures. Gyroid structures demonstrated superior mechanical performance and fatigue resistance compared to stochastic structures, with etching providing more pronounced benefits in these aspects. In-vitro biocompatibility tests showed high cytocompatibility for both as-built and etched samples, with etched samples exhibiting notably improved cell viability. The study also highlights the importance of design and post-processing in optimizing the performance of Ti64 components for biomedical ***/valueThe comparative analysis between as-built and etched conditions, alongside considering different lattice designs, provides valuable information for developing advanced biomedical implants. The demonstration of en

关键词： Fatigue Additive manufacturing Powder bed fusion laser beam

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Functional verification of Arithmetic Logic Unit and Instruction Fetch Unit of a 32-bit Rv321M ISA based RISC-v Processor 10

Functional Verification of Arithmetic Logic Unit and Instruc...

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10th IEEE International conference on Electronics, Computing and Communication technologies (IEEE CONECCT)

作者： verma, Reshma Hrishikesh, C. S. Shrinivasan, Lakshmi Ramaiah Inst Technol Dept Elect & Comminicat Bengaluru Karnataka India

ISBN: (纸本)9798350385939;9798350385922

verification is a pivotal process in the design life cycle of integrated circuits, ensuring the functionality aligns with the chosen architecture. This paper focuses on the verification of the Arithmetic Logic Unit (ALU) and Instruction Fetch Unit (IFU) of a processor using Universal verification Methodology (UvM). By adopting a simulation-based approach, this project aims to enhance confidence in the conformance of the ALU and IFU design to their specifications. Through this project, we aim to establish a robust verification methodology using UvM for validating the ALU and IFU components in a processor design. The adoption of UvM promises to enhance verification quality, scalability, and reusability while ensuring adherence to processor specifications.

关键词： Processor verification ALU verification IFU verification Universal verification Methodology (UvM) RISC-v Processor Functional verification Simulation - Based Approach vLSI design Conformance Testing design under Test (DUT)

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A novel quality-by-design assisted HPLC-DAD method for the simultaneous quantification of tryptophan, tryptophol, and voriconazole for early diagnosis and prognosis of fungal infections decoding quorum sensing phenomenon

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JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL technologies IN THE biomedical AND LIFE SCIENCES 2025年 1257卷 124571页

作者： Saleh, Ahmed M. Saleh, Ola A. Hassan, Rabeay Y. A. Badawey, Amr M. Marzouk, Hoda M. Horus Univ Fac Pharm Pharmaceut Chem Dept Horus 34518 Egypt Natl Res Ctr Pharmaceut & Drug Ind Res Inst Med & Pharmaceut Chem Dept Giza 12622 Egypt Zewail City Sci & Technol Biosensors Res Lab 6th October City 12578 Giza Egypt Natl Res Ctr NRC Appl Organ Chem Dept Dokki 12622 Giza Egypt Cairo Univ Fac Pharm Pharmaceut Analyt Chem Dept Kasr El Aini St ET-11562 Cairo Egypt

For the first time, a comprehensive analytical approach is introduced that simultaneously quantifies a metabolic precursor (tryptophan), a quorum-sensing biomarker for fungal infections (tryptophol), and an antifungal drug (voriconazole) within a single platform using reversed-phase high-performance liquid chromatography coupled with diode array detection (HPLC-DAD). The method utilizes a Pursuit PFP column featuring a unique pentafluorinated structure, with a mobile phase of methanol: water (60:40, v/v), a flow rate of 1.0 mL/min, and a detection wavelength set at 254.0 nm. An Analytical quality-by-design (AQbD) methodology was employed, incorporating a full factorial design for optimal method development. validation was performed in accordance with ICH guidelines, demonstrating exceptional linearity (2.0-60.0 mu g/mL) for all target analytes, along with high precision, accuracy, and system suitability. Furthermore, the method proved robust and versatile when applied to complex matrices, including spiked human serum and pharmaceutical tablet formulations. Noteworthy is the integration of green and white chemistry principles for evaluating the method's sustainability, representing a significant advancement in analytical technique development. Assessment of greenness, blueness, and whiteness with AGREE, ComplexGAPI index, BAGI and RGB 12 Tools, respectively. This innovative analytical platform provides a powerful tool for the early detection and real-time therapeutic monitoring of fungal infections. By enabling the simultaneous analysis of a metabolic marker, a quorum-sensing specific biomarker, and an antifungal agent, the method advances personalized medicine. It offers a novel, efficient, and sustainable solution for the personalized management of fungal infections, enhancing both diagnostic and therapeutic strategies.

关键词： Analytical quality-by-design Fungal infections HPLC-DAD Spiked human serum Tryptophan Tryptophol voriconazole Sustainable analysis

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A 69 μm² Sub-nW/kHz Capacitor-less Ring Oscillator for Ultra-Miniaturized Implants 13

A 69 μm<SUP>2</SUP> Sub-nW/kHz Capacitor-less Ring Oscillat...

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13th International conference on Modern Circuits and Systems technologies (MOCAST)

作者： Meimandi, Ali Barbruni, Gian Luca Carrara, Sandro Ecole Polytech Fed Lausanne Bio CMOS Interfaces Lab BCI Lausanne Switzerland

ISBN: (纸本)9798350385434;9798350385427

This paper presents an ultra-miniaturized, ultra-low-power, capacitor-less CMOS ring oscillator based on dynamic leakage suppression technique. Measurement results demonstrated an oscillation frequency of 21.89 kHz and a power consumption of 7.9 nW for a supply voltage of 0.4 v. The circuit occupies 69 mu m(2) in 180 nm CMOS process. The line sensitivity was measured at 37%/v with a temperature variation of 15349 ppm/degrees C. The stability analysis showed a central frequency of 21.89 kHz with a standard deviation of 10.92 Hz. The circuit exhibits the lowest area consumption and supply voltage among the state-of-the-art. It also favors transistor down-scaling, being suitable for miniaturized and wirelessly powered biomedical implants.

关键词： CMOS design Ring oscillator Dynamic Leakage Suppression Logic Ultra-miniaturized Ultra-low power biomedical implants

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Energy Harvesting Integration with Air quality Monitoring Systems

Energy Harvesting Integration with Air Quality Monitoring Sy...

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International conference on Smart Applications, Communications and Networking (SmartNets)

作者： Santana, E. S. Arenas, L. A. O. Liberado, E. v. Sao Paulo State Univ UNESP Dept Control & Automat Engn Sorocaba Brazil Sao Paulo State Univ UNESP Dept Environm Engn Sorocaba Brazil

ISBN: (纸本)9798350385328;9798350385335

Optimizing energy flow is as crucial as challenging in air quality monitoring systems, particularly when applied in remote regions where reduced maintenance of energy storage components is required. However, the development of energy harvesting technologies and their integration with air quality monitors can be a suitable solution to design self-powered systems with optimum energy storage usage. Hence, this paper presents a basic framework of the elements of air quality monitoring systems and energy harvesting technologies, and briefly discusses their integration through the analysis of applications reported in the literature.

关键词： air quality energy harvesting power management self-powered systems energy optimization

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Analysis of the Impact of Orthogonality in the Readability of the OBO Foundry Ontologies 12th

Analysis of the Impact of Orthogonality in the Readability o...

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12th World conference on Information Systems and technologies (WorldCIST)

作者： Redondo-Aniorte, Francisco Javier Abad-Navarro, Francisco Fernandez-Breis, Jesualdo Tomas Univ Murcia Dept Informat & Sistemas CEIR Campus Mare NostrumIMIB Pascual Parrilla Murcia 30100 Spain

ISBN: (纸本)9783031602207;9783031602214

There is an increasing use of ontologies in the biomedical domain, so ensuring their high quality is required. Reuse of content is a best practice in ontology engineering, whose non-optimal implementation may lead to lead to loss of information and, therefore, of readability of the ontology for both humans and machines. We present twelve metrics for analyzing lack of human readability in ontologies. We applied these metrics to the OBO Foundry repository, which contains an orthogonal collection of biological and biomedical ontologies, and has content reuse as a design principle. For this study, we have also generated an orthogonal view of the repository, which can be seen as a single ontology representing the merged repository. The comparison between both perspectives permitted to identify that the readability for some types of entities and annotations decrease due to how reuse is implemented.

关键词： biomedical ontologies quality assurance readability OBO Foundry

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MODELING LIGHT-TISSUE INTERACTIONS IN PULSE OXIMETRY: EFFECT OF DEvICE design AND SKIN PIGMENTATION 17

MODELING LIGHT-TISSUE INTERACTIONS IN PULSE OXIMETRY: EFFECT...

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conference on design and quality for biomedical technologies XvII

作者： Moradi, Mousa vasudevan, Sandhya Bhusal, Anant Weininger, Sandy Chen, Yu Pfefer, Joshua Univ Massachusetts Dept Biomed Engn Amherst MA 01003 USA US FDA Ctr Devices & Radiol Hlth 10903 New Hampshire Ave Silver Spring MD 20993 USA

ISBN: (纸本)9781510669260;9781510669253

Pulse oximeters have traditionally been used for measuring oxygen saturation (SpO2), yet their widespread adoption has led to its expanded applications, including diagnostic uses like detecting hypoxemia during the COvID-19 pandemic. Recent research has identified unexpected errors, with discrepancies in SpO2 measurement accuracy and diagnostic efficacy based on race or skin pigmentation. The positive bias in SpO2 measurements, particularly in the critical range of 85-90%, poses a significant concern for clinical care. This study employs Monte Carlo simulations to model transmittance mode pulse oximetry and investigates whether these disparities can be attributed to variations in epidermal melanin volume fraction (Mf = 2-43%). The research aims to elucidate key mechanisms that may guide evaluation of clinical devices and the improvement of technology. Additionally, this study explores the effect of sensor/bandage reflectivity on sensitivity to the epidermal region. Simulation results reveal a significant impact of skin pigmentation on transmitted signals. Modulation ratios at 660 nm and 940 nm exhibit an inverse correlation with melanin fraction, notably more pronounced at 660 nm (20-25%) compared to 940 nm (6-12%). Modulation ratios and the magnitude of pigmentation dependence are shown to vary with SaO2. Calibration curves derived from simulations representing low Mf subjects generate positive bias when applied to data representing higher pigmentation subjects. The agreement of these results with recent clinical studies provides evidence that melanin content plays a key role in determining the accuracy of pulse oximeters.

关键词： Pulse Oximetry Monte Carlo Transmittance Pigmentation Modulation ratio

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