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Pharmacokinetics and Bioequivalence of Dienogest in Healthy Bangladeshi Female Volunteers: An Open-Label, Single-Dose, Randomized, Two-Way Crossover Study

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Open Journal of Obstetrics and Gynecology 2024年第5期14卷 779-789页

作者： Nusrat Mahmud Nafisa ahamed Uttom Kumar Bhowmik Sabrina Akter Tushi Nayan Ghosh Nithon Chandra Sahana Arifa Akram Md. alimur Reza BIRDEM General Hospital Dhaka Bangladesh Medical College for Women & Hospital Dhaka Bangladesh Novus Clinical Research Services Ltd. Dhaka Bangladesh National Institute of Laboratory Medicine & Referral Centre (NILMRC) Dhaka Bangladesh

Background: Dienogest is a potential treatment for pelvic pain associated with endometriosis, a condition of significant concern in gynaecology. The current study was conducted as a crossover-randomized bioequivalence assessment of two oral Dienogest 2 mg formulations, aiming to provide valuable insights for healthcare professionals and researchers in this field. Objective: The primary aim of this research was to evaluate and compare the pharmacokinetic characteristics of Dienogest 2 mg tablets. Dinogest (Dienogest 2 mg) tablets, manufactured by Nuvista Pharma Limited in Bangladesh, and Visanne (Dienogest 2 mg) tablets, manufactured by Bayer Pharma in Germany, were the test and reference formulations, respectively. Materials and Method: The study was an open-label, balanced, randomized, two treatments, two sequences, two periods, two-way crossover, laboratory blind, single oral dose bioequivalence study conducted in healthy adult females under fasting conditions. The study was carried out on 13 healthy, non-pregnant female subjects, and all the subjects completed both study periods with a 15-day washout in between. Randomization was used to assign the test and reference formulations to the subjects. Following each oral administration, a series of blood samples were obtained at different time intervals from pre-dose to 72 hours post-dose and analyzed for Dienogest concentrations using a validated bio-analytical method. A standard non-compartmental model was used to analyze the pharmacokinetic parameters. The primary pharmacokinetic parameters were peak plasma drug concentration (Cmax), the area under the plasma concentration-time curve from time zero to time t (AUC0–t), and AUC from t = 0 to infinity (AUC0–∞). The other PK parameters included time to reach Cmax (Tmax), terminal elimination rate constant (Kel), and half-life (t1/2). Result: The ratios and 90% CI for the geometric mean test/re

关键词： Dienogest Bioequivalence Study Endometriosis Novus CRSL

Pharmacokinetic Comparison and Bioequivalence Evaluation of Two 20-mg Vonoprazan Fumarate Tablets in Bangladeshi Healthy Male Subjects

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Journal of Biosciences and Medicines 2024年第8期12卷 230-243页

作者： Md. alimur Reza Uttom Kumar Bhowmik Sabrina Akter Tushi Nayan Ghosh Nithon Chandra Sahana Md. Ashraful Islam Nafisa ahamed Arifa Akram Novus Clinical Research Services Ltd. Dhaka Bangladesh Medical College for Women & Hospital Dhaka Bangladesh National Institute of Laboratory Medicine & Referral Centre (NILMRC) Dhaka Bangladesh

Background: Vonoprazan fumarate, a novel potassium-competitive acid blocker, outperforms traditional proton pump inhibitors in acid suppression and can be effectively combined with antibiotics to eradicate Helicobacter pylori. Objective: The study aimed to determine if two Vonoprazan formulations—Vonoprazan Fumarate 20 mg Tablet of Beximco Pharmaceuticals Limited, Bangladesh (test product) and Takecab 20 mg Tablet of Takeda Pharmaceutical Company Limited, Japan (reference product)—met FDA’s bioequivalence requirements by comparing their pharmacokinetic characteristics in healthy Bangladeshi adults. Methods: This was a single-center, randomized, open-label, two-period, two-sequence, laboratory-blind, double-crossover experiment. After 10 hours of fasting, 18 subjects were randomly assigned to receive a single oral dose of either formulation. During each treatment period, blood samples were collected at specific times (pre-dose and up to 48 hours post-dose) to measure plasma Vonoprazan levels using liquid chromatography-tandem mass spectrometry. A non-compartmental model was used to calculate pharmacokinetic parameters using the plasma drug concentration-time profile. A statistical comparison of the pharmacokinetic parameters of the two formulations of the test and reference product was conducted using SAS® statistical software to assess the bioequivalence. Primary pharmacokinetic parameters (Cmax, AUC0-t, and AUC0-∞) and secondary parameters (Tmax, T1/2, Kel, and AUC extrapolation) were calculated for both drug formulations. If the confidence intervals for the natural log-transformed Cmax, AUC0-t, and AUC0-∞ values fell between 80% and 125%, the drug products would be considered bioequivalent. Result: The geometric mean ratio of Vonoprazan between the test and reference groups was found to be 109.04% (99.47% - 119.53%), 101.37% (95.58% - 107.50%), and 101.24% (95.43% - 107.41%), with 90% confidence intervals (CIs) for the Cmax, AUC0–t, and AUC0–∞, and these outcomes

关键词： Bioequivalence Vonoprazan Pharmacokinetics

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高速垂直腔面发射激光器热管理研究进展

激光与光电子学进展 2024年第15期 24-32页

作者：孙家辉田思聪 ahamed Mansoor 王宇昊潘绍驰徐汉阳佟存柱王立军 Dieter Bimberg 中国科学院长春光学精密机械与物理研究所Bimberg中德绿色光子学研究中心中国科学院大学中国科学院长春光学精密机械与物理研究所发光学及应用国家重点实验室柏林工业大学固体物理研究所纳米光学中心

垂直腔面发射激光器（VCSEL）与并行光传输、光互连等领域的数据传输需求相契合，能够应用于单通道和并行光互联网络，是宽带以太网、高速数据通信中关键的光电子器件。而热效应严重限制了VCSEL的带宽等高速调制性能并影响输出的稳定性... 详细信息

垂直腔面发射激光器（VCSEL）与并行光传输、光互连等领域的数据传输需求相契合，能够应用于单通道和并行光互联网络，是宽带以太网、高速数据通信中关键的光电子器件。而热效应严重限制了VCSEL的带宽等高速调制性能并影响输出的稳定性，通过优化电流分布、调整氧化孔径、减薄衬底、使用高热导率的材料、键合热沉等方式有助于VCSEL的热耗散。本文综述了VCSEL热管理等方面的研究进展，这对于提升其高速调制性能至关重要，最后介绍了本课题组最新设计的具有高效散热结构的高速多孔孔径VCSEL。

关键词：高速垂直腔面发射激光器多孔孔径垂直腔面发射激光器热效应调制带宽传输速率

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单模电注入面发射激光器研究进展

激光与光电子学进展 2024年第17期 1-14页

作者：艾星辰田思聪 Mansoor ahamed 孙家辉王宇昊潘绍驰佟存柱王立军 Bimberg Dieter 中国科学院长春光学精密机械与物理研究所Bimberg中德绿色光子学研究中心中国科学院大学中国科学院长春光学精密机械与物理研究所发光学及应用国家重点实验室柏林工业大学固体物理研究所纳米光学中心

互联网、超算中心、数据中心光互连等高速光通信领域，以及激光雷达、显示等应用，均对半导体激光器提出单模、单偏振态、高速、高功率等更高性能要求。本文梳理了以垂直腔面发射激光器（VCSEL）、光子晶体面发射激光器等为主的电注入... 详细信息

互联网、超算中心、数据中心光互连等高速光通信领域，以及激光雷达、显示等应用，均对半导体激光器提出单模、单偏振态、高速、高功率等更高性能要求。本文梳理了以垂直腔面发射激光器（VCSEL）、光子晶体面发射激光器等为主的电注入表面发射型半导体激光器的研究进展，包括：为了同时实现单模和单偏振性，设计表面光栅、浮雕和高折射率对比度光栅VCSEL；为了实现单模高速特性，引入锌扩散区、建立横向耦合腔、构建多孔结构氧化限制VCSEL；为了实现单模、高功率性，采用构建慢光表面光栅负载VCSEL、引入锌扩散区、设计多结或多氧化孔径VCSEL等方式；为了实现突破性的单模、高功率、极小发散角等性能，采用光子晶体面发射激光器。最后对面发射激光器发展趋势做出展望。

关键词：垂直腔面发射激光器单模光高速传输高功率激光光子晶体面发射激光器

Anomaly Detection Framework in Fog-to-Things Communication for Industrial Internet of Things

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Computers, Materials & Continua 2022年第10期73卷 1067-1086页

作者： Tahani alatawi ahamed aljuhani College of Computing and Information Technology University of TabukTabuk71491Saudi Arabia

The rapid development of the Internet of Things(IoT)in the industrial domain has led to the new term the Industrial Internet of Things(IIoT).The IIoT includes several devices,applications,and services that connect the physical and virtual space in order to provide smart,cost-effective,and scalable *** the IIoT has been deployed and integrated into a wide range of industrial control systems,preserving security and privacy of such a technology remains a big *** anomaly-based Intrusion Detection System(IDS)can be an effective security solution for maintaining the confidentiality,integrity,and availability of data transmitted in IIoT *** this paper,we propose an intelligent anomalybased IDS framework in the context of fog-to-things communications to decentralize the cloud-based security solution into a distributed architecture(fog nodes)near the edge of the data *** anomaly detection system utilizes minimum redundancy maximum relevance and principal component analysis as the featured engineering methods to select the most important features,reduce the data dimensionality,and improve detection *** the classification stage,anomaly-based ensemble learning techniques such as bagging,LPBoost,RUSBoost,and Adaboost models are implemented to determine whether a given flow of traffic is normal or *** validate the effectiveness and robustness of our proposed model,we evaluate our anomaly detection approach on a new driven IIoT dataset called XIIoTID,which includes new IIoT protocols,various cyberattack scenarios,and different attack *** experimental results demonstrated that our proposed anomaly detection method achieved a higher accuracy rate of 99.91%and a reduced false alarm rate of 0.1%compared to other recently proposed techniques.

关键词： Anomaly detection anomaly-based IDS fog computing Internet of Things(IoT) Industrial Internet of Things(IIoT) IDS Industrial Control Systems(ICSs)

Anomaly Detection for Internet of Things Cyberattacks

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Computers, Materials & Continua 2022年第7期72卷 261-279页

作者： Manal alanazi ahamed aljuhani College of Computing and Information Technology University of TabukTabuk71491Saudi Arabia

The Internet of Things(IoT)has been deployed in diverse critical sectors with the aim of improving quality of service and facilitating human *** IoT revolution has redefined digital services in different domains by improving efficiency,productivity,and *** service providers have adapted IoT systems or plan to integrate them as integral parts of their systems’operation;however,IoT security issues remain a significant *** minimize the risk of cyberattacks on IoT networks,anomaly detection based on machine learning can be an effective security solution to overcome a wide range of IoT *** various detection techniques have been proposed in the literature,existing detection methods address limited cyberattacks and utilize outdated datasets for *** this paper,we propose an intelligent,effective,and lightweight detection approach to detect several IoT *** proposed model includes a collaborative feature selection method that selects the best distinctive features and eliminates unnecessary features to build an effective and efficient detection *** the detection phase,we also proposed an ensemble of learning techniques to improve classification for predicting several different types of IoT *** experimental results show that our proposed method can effectively and efficiently predict several IoT attacks with a higher accuracy rate of 99.984%,a precision rate of 99.982%,a recall rate of 99.984%,and an F1-score of 99.983%.

关键词： Anomaly detection anomaly-based IDS cybersecurity feature selection Internet of Things(IoT) intrusion detection

cis-trans Engineering： Advances and Perspectives on Customized Transcriptional Regulation in Plants

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Molecular Plant 2018年第7期11卷 886-898页

作者： Ankita Shrestha ahamed Khan Nrisingha Dey Division of Microbial and Plant Biotechnology Institute of Life Sciences Department of Biotechnology Government of India Chandrasekharpur Bhubaneswar Odisha India These authors contributed equally to this article.

Coordinated transcriptional control employing synthetic promoters and transcription factors （TFs） can be used to achieve customized regulation of gene expression in planta. Synthetic promoter technology has yielded a series of promoters with modified cis-regulatory elements that provide useful tools for efficient modulation of gene expression. In addition, the use of zinc fingers （ZFs）, transcription activator-like effectors （TalEs）, and catalytically inactive clustered regularly interspaced short palindromic repeats （CRISPR）-associated protein 9 （dCas9） has made it feasible to engineer TFs that can produce targeted gene expression regulation; these approaches are particularly effective when artificial TFs are coupled with transcriptional activators or repressors. This review focuses on strategies used to engineer both promoters and TFs in the context of targeted transcriptional regulation. We also discuss the creation of synthetic inducible platforms, which can be used to impart stress tolerance to plants. We propose that combinatorial ＂cis-trans engineering＂ using a CRISPR-dCas9-based bipartite module could be used to regulate the expression of multiple target genes. This approach provides an attractive tool for introduction of specific qualitative traits into plants, thus enhancing their overall environmental adaptability.

关键词： cis engineering trans engineering synthetic TFs dCas9 bipartite module

Anomaly Detection for Industrial Internet of Things Cyberattacks

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Computer Systems Science & Engineering 2023年第3期44卷 2361-2378页

作者： Rehab alanazi ahamed aljuhani College of Computing and Information Technology University of TabukTabuk71491Saudi Arabia

The evolution of the Internet of Things(IoT)has empowered modern industries with the capability to implement large-scale IoT ecosystems,such as the Industrial Internet of Things(IIoT).The IIoT is vulnerable to a diverse range of cyberattacks that can be exploited by intruders and cause substantial reputational andfinancial harm to *** preserve the confidentiality,integrity,and availability of IIoT networks,an anomaly-based intrusion detection system(IDS)can be used to provide secure,reliable,and efficient IIoT *** this paper,we propose an anomaly-based IDS for IIoT networks as an effective security solution to efficiently and effectively overcome several IIoT *** proposed anomaly-based IDS is divided into three phases:pre-processing,feature selection,and *** the pre-processing phase,data cleaning and nor-malization are *** the feature selection phase,the candidates’feature vectors are computed using two feature reduction techniques,minimum redun-dancy maximum relevance and neighborhood components *** thefinal step,the modeling phase,the following classifiers are used to perform the classi-fication:support vector machine,decision tree,k-nearest neighbors,and linear discriminant *** proposed work uses a new data-driven IIoT data set called *** experimental evaluation demonstrates our proposed model achieved a high accuracy rate of 99.58%,a sensitivity rate of 99.59%,a specificity rate of 99.58%,and a low false positive rate of 0.4%.

关键词： Anomaly detection anomaly-based IDS Industrial Internet of Things(IIoT) IoT industrial control systems(ICSs) X-IIoTID

Intelligent Intrusion Detection for Industrial Internet of Things Using Clustering Techniques

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Computer Systems Science & Engineering 2023年第9期46卷 2899-2915页

作者： Noura alenezi ahamed aljuhani College of Computing and Information Technology University of TabukTabuk71491Saudi Arabia

The rapid growth of the Internet of Things(IoT)in the industrial sector has given rise to a new term:the Industrial Internet of Things(IIoT).The IIoT is a collection of devices,apps,and services that connect physical and virtual worlds to create smart,cost-effective,and scalable *** the IIoT has been implemented and incorporated into a wide range of industrial control systems,maintaining its security and privacy remains a significant *** the IIoT contexts,an intrusion detection system(IDS)can be an effective security solution for ensuring data confidentiality,integrity,and *** this paper,we propose an intelligent intrusion detection technique that uses principal components analysis(PCA)as a feature engineering method to choose the most significant features,minimize data dimensionality,and enhance detection *** the classification phase,we use clustering algorithms such as K-medoids and K-means to determine whether a given flow of IIoT traffic is normal or attack for binary classification and identify the group of cyberattacks according to its specific type for multi-class *** validate the effectiveness and robustness of our proposed model,we validate the detection method on a new driven IIoT dataset called *** performance results showed our proposed detection model obtained a higher accuracy rate of 99.79%and reduced error rate of 0.21%when compared to existing techniques.

关键词： Anomaly detection anomaly-based IDS industrial internet of things(IIoT) internet of things