Setup Requirements Research Articles

Enhancing Surveillance Systems with Cost-Effective Ultrasonic Radar for Object Detection and Tracking

Object detection is critical in surveillance systems because it enables timely identification of unauthorized objects, which is essential for maintaining security and mitigating risks. Existing approaches to surveillance typically suffer from limited coverage, variable detection range, moderate accuracy, high cost, and complex setup requirements. This article presents an approach to object detection using microcontroller-based ultrasonic sensors. Our approach leverages four distinct processing phases to create a radar-like system capable of real-time detection and autonomous decision-making. In this study, we conducted experiments by integrating more than six peripheral modules with the Arduino platform. By evaluating 17 diverse test cases in various scenarios and environments, the approach demonstrated enhanced object tracking and robustness compared to existing methods. The system effectively detects objects within the targeted area, providing precise distance measurements (around 50 cm) and position information (0 to 360 degrees). Moreover, our approach enabled the identification of three risk zones—medium, high-risk, and mild danger—within the critical region, contributing to improved security and risk management. The results reveal the system’s effectiveness in real-time detection, accurate distance estimation, and comprehensive risk assessment. Overall, our study significantly contributes to the advancement of object detection technology by effectively addressing the limitations of existing methods and offering a cost-effective and practical solution. Our research has the potential to monitor objects in surveillance systems across various domains, with significant implications for enhancing security, risk mitigation, and monitoring in industries reliant on effective object detection systems. Jagannath University Journal of Science, Volume 11, Number 1, June 2024, pp. 157−171

Antimicrobial Resistance Development in vitro: Adaptive Laboratory Evolution Method (Review)

INTRODUCTION. High rates of emergence and spread of antimicrobial resistance (AMR) necessitate the rapid development of novel antibacterial medicinal products. The assessment of the microbial potential for AMR development under controlled conditions in vitro can save resources during drug development and marketing authorisation and contribute to creating the most effective medicinal products.AIM. The aim was to determine the possibility of the use of the adaptive laboratory evolution (ALE) method to study the development of antimicrobial resistance.DISCUSSION. A variety of methods can be used to investigate the mechanisms of AMR and the influence of medicinal products on the evolution of bacteria towards AMR. One of the options is the ALE method. ALE experiments are conducted under controlled conditions with prolonged exposure of microorganisms to an antibacterial agent. ALE experiments can include serial transfers of microorganisms to fresh liquid media or Petri dishes, as well as continuous cultivation of microorganisms in a chemostat. ALE protocols are used to develop resistance to different antibacterial agents and require meticulous control of the experimental conditions. To obtain reliable results in an experiment, it is necessary to identify parameters that may affect AMR development in microorganisms. These parameters include but are not limited to the concentration of the antibacterial agent, the number of consecutive passages, the duration of incubation.CONCLUSIONS. To achieve the necessary conditions for resistant microorganisms to form, it is essential to adhere strictly to ALE setup requirements, such as using antibacterial agents at subinhibitory or dynamically increasing concentrations (relative to the minimum inhibitory concentrations for the ancestral strain), performing a certain number of passages for ≥20 generations, and incubating cultures until the stationary phase. Despite the fact that ALE experiments are rather lengthy, these studies can reduce the potential waste of resources on developing new compounds that may have to be discontinued at the stage of production because of AMR development.

Development of a Semi-Autonomous Pulse and Receive Concrete Inspection System

Concrete structures are being subjected to increasing loads and used beyond their intended lifespan. When combined with operators shrinking maintenance budgets it is imperative structures are monitored for damage. Acoustic Emission (AE) and AE Tomography offer a method for damage detection and characterisation. However, they are encumbered by their equipment and setup requirements, and best used on areas where damage is already known to have occurred. An autonomous pulse catch system could be used to identify these areas. To explore the potential of such a system, seven concrete beams differentiated by their aggregate size were tested using an automated pulse and receive system. The effect of aggregate size, and pulse frequency on attenuation and wavespeed are investigated. The pulse regime consisted of narrowband pulses ranging from 30 kHz to 500 kHz. The results show that high frequency pulses experienced greater attenuation than low frequency pulses. Whilst a link appears between the size of the aggregate and the rate of attenuation of high frequency signals. A strong negative correlation between amplitude loss and pulse frequency was observed. For the specimen containing coarse aggregate, pulse velocity was constant between 100 kHz and 500 kHz, whereas specimens containing coarse aggregate experienced frequency dependant attenuation. This testing shows the significant potential for an automated pulse and receive system, which could lead to the development of an autonomous health monitoring system. In addition, the approach can be instrumental in developing large data sets, that can be used in Machine Learning processes, to develop a deeper understanding of AE signal propagation in concrete materials.

Methods to quantify gait rehabilitation following lower limb fractures

Lower limb fragility fractures require long-term rehabilitation and are also very expensive to treat. Clinically, early weight bearing and walking stability were reported as key measures of fracture restoration. This study introduces methods to numerically quantify these performance indices for a range of ankle and knee joint fractures. As a follow-up of initial treatment, experimental data was collected using force plates from 367 subjects divided into seven groups: ankle fracture (AF), lower leg ankle fracture (AL), calcaneus foot fracture (CF), knee tibia fracture (KF), knee patella fracture (KP), kneecap rupture (KR), and normal limb (NL). For each joint, data was analysed to evaluate intralimb and interlimb weight-bearing and walking stability for all fracture conditions. These thresholds were statistically compared with normal subjects. Some advantages of evaluating fracture restoration indices over the others include:•to quantify fracture restoration (weight-bearing, walking stability, and gait symmetry) using minimum setup and signal requirements.•to provide comprehensive tools to assess and overcome fracture-associated complications through a detailed preview of fractured limb functionality during subphases of a gait cycle.•in clinical research, such assessments are important as a reference to evaluate existing or new rehabilitative interventions.

A Comprehensive Review of Indentation of Gels and Soft Biological Materials

Abstract Indentation measurement has emerged as a widely adapted technique for elucidating the mechanical properties of soft hydrated materials. These materials, encompassing gels, cells, and biological tissues, possess pivotal mechanical characteristics crucial for a myriad of applications across engineering and biological realms. From engineering endeavors to biological processes linked to both normal physiological activity and pathological conditions, understanding the mechanical behavior of soft hydrated materials is paramount. The indentation method is particularly suitable for accessing the mechanical properties of these materials as it offers the ability to conduct assessments in liquid environment across diverse length and time scales with minimal sample preparation. Nonetheless, understanding the physical principles underpinning indentation testing and the corresponding contact mechanics theories, making judicious choices regarding indentation testing methods and associated experimental parameters, and accurately interpreting the experimental results are challenging tasks. In this review, we delve into the methodology and applications of indentation in assessing the mechanical properties of soft hydrated materials, spanning elastic, viscoelastic, poroelastic, coupled viscoporoelastic, and adhesion properties, as well as fracture toughness. Each category is accomplished by the theoretical models elucidating underlying physics, followed by ensuring discussions on experimental setup requirements. Furthermore, we consolidate recent advancements in indentation measurements for soft hydrated materials highlighting its multifaceted applications. Looking forward, we offer insights into the future trajectory of the indentation method on soft hydrated materials and the potential applications. This comprehensive review aims to furnish readers with a profound understanding of indentation techniques and a pragmatic roadmap of characterizing the mechanical properties of soft hydrated materials.

Advancements in biosensors for cancer detection: revolutionizing diagnostics.

Cancer stands as the reigning champion of life-threatening diseases, casting a shadow with the highest global mortality rate. Unleashing the power of early cancer treatment is a vital weapon in the battle for efficient and positive outcomes. Yet, conventional screening procedures wield limitations of exorbitant costs, time-consuming endeavors, and impracticality for repeated testing. Enter bio-marker-based cancer diagnostics, which emerge as a formidable force in the realm of early detection, disease progression assessment, and ultimate cancer therapy. These remarkable devices boast a reputation for their exceptional sensitivity, streamlined setup requirements, and lightning fast response times. In this study, we embark on a captivating exploration of the most recent advancements and enhancements in the field of electrochemical marvels, targeting the detection of numerous cancer biomarkers. With each breakthrough, we inch closer to a future where cancer's grip on humanity weakens, guided by the promise of personalized treatment and improved patient outcomes. Together, we unravel the mysteries that cancer conceals and illuminate a path toward triumph against this daunting adversary. This study celebrates the relentless pursuit of progress, where electrochemical innovations take center stage in the quest for a world free from the clutches of carcinoma.

Effect of Flowrate and Pressure on the Crossflow Filtration in Textile Wastewater Treatment by Commercial UF Membrane

Textile industries are one of the greatest wastewater producers as they require a significant amount of water to be used in the dyeing and finishing processes of textile manufacturing. The number of unit operations in the technological process, the product range, the bath ratio, the mass of fiber in relation to the bath volume, and the finishing machine are some variables that will affect water consumption in the textile industry. As a result, generally, a typical textile plant may consume a volume of water between 100,000 and 300,000 m3 annually. As textiles address a substantial portion of human requirements, it is predicted that by 2050, there will be 160 million metric tonnes, three times as much clothing as there is today. Membrane technology in wastewater treatment is a recent interest arising technique and garnering the industrial application’s interest, owing to its ease of setup and low energy requirement. Crossflow membrane filtration is commonly used in the industry, attributed to its tangential flow across the membrane mechanism, leading to low fouling. This study investigated the textile wastewater’s effluents using crossflow ultrafiltration (UF) membrane filtration. The effect of the operating parameter in terms of pressure and flowrate of the crossflow system were performed to evaluate it permeate flux performance. The study’s outcome reveals pressure increases from 2 bar to 4 bar, the water flux enhances dramatically from 156.26 L/m2hr to 591.98 L/m2hr, and the water flux further increases constantly from 4 bar to 10 bar. On the other hand, the flowrate positively affects the permeate flux, where the flux was enhanced from 651.01 L/m2hr to 726.08 L/m2hr when adjusting the flow rate from 2 LPM to 6 LPM. The results from this study suggested that crossflow membrane filtration system could be commercially feasible due to its permeate flux performance.

Delta-T Flicker Noise Demonstrated with Molecular Junctions.

Electronic flicker noise is recognized as the most abundant noise in electronic conductors, either as an unwanted contribution or as a source of information on electron transport mechanisms and material properties. This noise is typically observed when a voltage difference is applied across a conductor or current is flowing through it. Here, we identify an unknown type of electronic flicker noise that is found when a temperature difference is applied across a nanoscale conductor in the absence of a net charge current or voltage bias. The revealed delta-T flicker noise is demonstrated in molecular junctions and characterized using quantum transport theory. This noise is expected to arise in nanoscale electronic conductors subjected to unintentional temperature gradients, where it can be a performance-limiting factor. On the positive side, delta-T flicker noise can detect temperature differences across a large variety of nanoscale conductors, down to atomic-scale junctions with no special setup requirements.

AVDOS-VR: Affective Video Database with Physiological Signals and Continuous Ratings Collected Remotely in VR

Investigating emotions relies on pre-validated stimuli to evaluate induced responses through subjective self-ratings and physiological changes. The creation of precise affect models necessitates extensive datasets. While datasets related to pictures, words, and sounds are abundant, those associated with videos are comparatively scarce. To overcome this challenge, we present the first virtual reality (VR) database with continuous self-ratings and physiological measures, including facial EMG. Videos were rated online using a head-mounted VR device (HMD) with attached emteqPRO mask and a cinema VR environment in remote home and laboratory settings with minimal setup requirements. This led to an affective video database with continuous valence and arousal self-rating measures and physiological responses (PPG, facial-EMG (7x), IMU). The AVDOS-VR database includes data from 37 participants who watched 30 randomly ordered videos (10 positive, neutral, and negative). Each 30-second video was assessed with two-minute relaxation between categories. Validation results suggest that remote data collection is ecologically valid, providing an effective strategy for future affective study designs. All data can be accessed via: www.gnacek.com/affective-video-database-online-study.

A Study on the Relationship of Heat Exchanger Design Parameters with Water Lily Stem Profile by Robust Statistical Method

The study has successfully modeled and simulated a polymorphic tube based on the water lily stem using the robust statistical method and software. Taguchi analysis shows that the size factor E (Cross-section length of inner hole) with the effects values 39.89% has the most significant influence on the response temperature difference ((Δt) 0C). The size factor A (Peduncle diameter) has the most critical influence on the response pressure difference (ΔP (Pa)), with an effect value of 42.88%. The size factor C (Large inner hole diameter) with the significant effect value of 34.78% affects the response velocity difference (Δv (m/s)) the most. By ANOVA analysis, the results of response temperature difference analysis show that both the T-value and P-value of the size factor E (Cross-section length of inner hole) reach values that satisfy the setup requirements, with T-value reaching the most significant T-value 3.85 and the P-value 0.043 being smaller than the benchmark value 0.05, the final result indicated the size factor E (Cross-section length of inner hole) is the factor that has the most significant influence on the temperature difference of the model. For pressure difference, the results show that both the T-value and P-value of the size factor A (Peduncle diameter) reach values that satisfy the setup requirements, with the T-value reaching the largest T-value 12.19 and P-value 0.001 being smaller than the benchmark value of 0.05, the size factor A (Peduncle diameter) is the factor that has the most significant influence on the pressure difference of the model. For velocity difference, the results show that both the T-value and P-value of the size factor C (Large inner hole diameter) reach values that satisfy the set requirements, with the T-value reaching the largest T-value of 3.72 and the P-value 0.047 being smaller than the benchmark value 0.05, the size factor C (Large inner hole diameter) is the factor that has the most significant influence on the velocity difference of the model. Minitab software verification based on the Means graph drawn by Minitap17 software, the results show the best combination for response temperature difference is A3-B2-C1-D2-E2. Similarly, the best combination for response pressure and velocity differences is A2-B2-C3-D1-E1 and A2-B3-C2-D1-E3, respectively.

Characterization of Objective Skin Color Changes during and after Breast and Chest Wall Radiotherapy and Correlation with Radiation-Induced Skin Toxicity in Breast Cancer Patients, Including Patients with Skin of Color

Radiation dermatitis (RD) is common among women undergoing breast and chest wall radiotherapy (RT); however, existing scales to assess the severity of RD are subjective and do not account for variability in skin of color (SOC). For instance, the Common Terminology Criteria for Adverse Events (CTCAE) criteria do not include hyperpigmentation in the grading scale. There is data indicating worse RD in African American and Hispanic patients; however, the rate and severity in SOC remains unknown given the lack of data using objective measures of RD. Spectrophotometry is one method to quantify the appearance of color by measuring spectral characteristics without the bias associated with subjective clinical scoring. We present a phase I prospective non-therapeutic clinical trial to objectively define SOC at baseline and evaluate spectrophotometric skin changes during and after breast or chest wall RT in parallel with physician-graded RD using CTCAE criteria. We hypothesize that there will be greater discrepancy between physician graded RD and objective measures of RD in patients with SOC in whom hyperpigmentation will be undercaptured by physician-grading. This is the first study intending to correlate SOC with objective changes after RT as a reliable indicator of RD. We offer a novel system for evaluating RD that is applicable to SOC. A total of 60 patients with localized breast cancer (stage 0-III) undergoing conventional whole breast or chest wall RT (50Gy/ 25 fx), hypofractionated whole breast RT (40.5Gy/15 fx) or ultrahypofractionated partial breast RT (6Gy x5), with or without regional nodal RT were enrolled. 3 skin color readouts using the Commission International de l'Eclairage 3D color system (l*, a*, b*) were measured within the radiation field using a spectrophotometer at baseline, once weekly during RT, 10 days post RT, 4 weeks and 12 months post RT. The spectrophotometer is a non-invasive, hand-held device that is used in the clinic room with no additional equipment or setup requirements. Data is automatically exported to a spreadsheet organized by timepoint and patient. The l* axis is a gray scale (0 = black, 100 = white) correlating with skin pigmentation and the a* axis describes red and green values correlating with erythema. The primary objective is to evaluate the changes from baseline in skin color readouts in the quadrant of tumor location during and after RT based on fractionation. The secondary objective is to evaluate changes within and across groups defined by baseline skin color. Exploratory objectives include evaluating the association of baseline color readouts and changes after RT with acute and late grade > 2 clinician-rated skin and subcutaneous tissue effects according to the CTCAE, v5.0, physician graded cosmesis and clinical interventions to treat RD, such as use of topical steroids and oral analgesics. As of January 2023, we have enrolled 100% of the planned patients. To be determined. To be determined. Clinical Study Identifier: S22-00192.

Optimal bi-planar gradient coil configurations for diamond nitrogen-vacancy based diffusion-weighted NMR experiments

IntroductionDiffusion weighting in optically detected magnetic resonance experiments involving diamond nitrogen-vacancy (NV) centers can provide valuable microstructural information. Bi-planar gradient coils employed for diffusion weighting afford excellent spatial access, essential for integrating the NV-NMR components. Nevertheless, owing to the polar tilt of roughly 55^{circ } of the diamond NV center, the primary magnetic field direction must be taken into account accordingly.MethodsTo determine the most effective bi-planar gradient coil configurations, we conducted an investigation into the impact of various factors, including the square side length, surface separation, and surface orientation. This was accomplished by generating over 500 bi-planar surface configurations using automated methods.ResultsWe successfully generated and evaluated coil layouts in terms of sensitivity and field accuracy. Interestingly, inclined bi-planar orientations close to the NV–NMR setup’s requirement, showed higher sensitivity for the transverse gradient channels than horizontal or vertical orientations. We fabricated a suitable solution as a three-channel bi-planar double-layered PCB system and experimentally validated the sensitivities at 28.7 mathrm mT/m/A and 26.8 mathrm mT/m/A for the transverse G_{x} and G_{y} gradients, and 26 mathrm mT/m/A for the G_{z} gradient.DiscussionWe found that the chosen relative bi-planar tilt of 35^{circ } represents a reasonable compromise in terms of overall performance and allows for easier coil implementation with a straight, horizontal alignment within the overall experimental setup.

Flexural response of 3D printed wood dust reinforced polymer composite

BackgroundThe rising environmental concern and inadequacy of conventional resources have led to increasing demand for new bio composite materials for various products and as a unique substitute for traditional and petroleum-based materials for different applications. The major constraint in most conventional bio composites manufacturing techniques is a mold or complex setup requirement, which leads to a lengthy manufacturing process. 3D printing manufacturing technique has extended a huge attention in current years because of its simplicity in manufacturing complex geometries. Problem StatementThis work is aimed to determine the flexural response of 3D printed wood –PLA composite. MethodDue to PLA's low mechanical properties, wood dust had added to enhance the properties. 22 wt% Wood dust filled PLA filament is procured with a 1.75 mm diameter. Five test samples have been printed with the fused deposited 3D printing technique. The flexural behavior – flexural strength, flexural Strain and flexural modulus, of the developed material, was tested with the help of a universal tensile testing machine. ResultsThe test results revealed the maximum flexural strength of the material is 36 MPa with a maximum Strain of 3.55% and modulus of 1.4 GPa. ConclusionWood dust acts as a filler and has improved the material’s flexibility, also, wood particles make the material porous and that affect the interfacial adhesion between wood and PLA polymer in 3D printing which reduce the strength.

Enhancing IAQ, thermal comfort, and energy efficiency through an adaptive multi-objective particle swarm optimizer-grey wolf optimization algorithm for smart environmental control

People in modern societies spend most of their time in buildings, and a considerable amount of energy is used to maintain indoor air quality (IAQ) and thermal comfort levels to ensure people's health and productivity. Thus, to ensure the energy efficiency of buildings, smart environmental control must be implemented through prediction and optimization based on artificial intelligence (AI) algorithms. However, rapid and accurate environmental control based on comprehensive consideration of IAQ, thermal comfort, and energy savings remains to be accomplished. Therefore, this paper describes the development and application of a multi-objective AI algorithm that can be deployed in practical environmental control to rapidly and accurately optimize the IAQ, thermal comfort levels, and energy efficiency of buildings. First, a database of indoor airflow and temperature distribution is established through computational fluid dynamics (CFD) simulations and chamber experiments. Then, with the database, the back-propagation neural network (BPNN) model is created to rapidly predict air pollution concentrations and thermal comfort levels. If these predictions using the BPNN model do not satisfy the setup requirements, an adaptive multi-objective particle swarm optimizer-grey wolf optimization (AMOPSO-GWO) algorithm is used to identify the optimal strategy for maximizing indoor air quality, thermal comfort levels, and energy saving. The results demonstrate that the BPNN-based AMOPSO-GWO algorithm has high predictive accuracy (>90%). The mean reduction in air pollution concentrations, increase in thermal comfort levels, and average energy savings are 31%, 45%, and 35%, respectively.

A Novel Method for Measuring, Visualizing, and Monitoring E-Collaboration

With its roots in the 1960s, e-collaboration has dramatically evolved and expanded over the past decades and became a globally adopted practice of teamwork. On the other hand, despite the development of e-collaboration technologies, the lack of true collaboration remains one of the main reasons for teamwork failures. However, traditional approaches to improving collaboration due to time-consuming, complicated, and expensive procedures do not meet the modern setup's requirements. This paper presents a new fast, simple, and low-cost method to improve e-collaboration through active engagement measures by analyzing data logs. The authors designed and ran a feedback system to mirror the participants' engagement during a collaborative engineering design course. The results of two case studies, including nine teams, suggest meaningful positive impacts of the method. The presented approach is applicable in upgrading e-collaboration platforms and further investigation on improving web-based collaborative learning and teamwork through monitoring dashboards and feedback systems.

Breaking the barriers to designing online experiments: A novel open-source platform for supporting procedural skill learning experiments

BackgroundMotor learning experiments are typically performed in laboratory environments, which can be time-consuming and require dedicated equipment/personnel, thus limiting the ability to gather data from large samples. To address this problem, some researchers have transitioned to unsupervised online experiments, showing advantages in participant recruitment without losing validity. However, most online platforms require coding experience or time-consuming setups to create and run experiments, limiting their usage across the field. MethodTo tackle this issue, an open-source web-based platform was developed (https://experiments.neurro-lab.engin.umich.edu/) to create, run, and manage procedural skill learning experiments without coding or setup requirements. The feasibility of the platform and the comparability of the results between supervised (n = 17) and unsupervised (n = 24) were tested in 41 naive right-handed participants using an established sequential finger tapping task. The study also tested if a previously reported rapid form of offline consolidation (i.e., microscale learning) in procedural skill learning could be replicated with the developed platform and evaluated the extent of interlimb transfer associated with the finger tapping task. ResultsThe results indicated that the performance metrics were comparable between the supervised and unsupervised groups (all p's > 0.05). The learning curves, mean tapping speeds, and micro-scale learning were similar to previous studies. Training led to significant improvements in mean tapping speed (2.22 ± 1.48 keypresses/s, p < 0.001) and a significant interlimb transfer of learning (1.22 ± 1.43 keypresses/s, p < 0.05). ConclusionsThe results show that the presented platform may serve as a valuable tool for conducting online procedural skill-learning experiments.

Multi-slice imaging with transmission K-domain transform method

A transmission K-domain transform method was proposed to realize multi-slice imaging by using a light sheet to illuminate a thick sample and a high pass filter to capture the complex amplitude of its image. The image of the lighted sample volume at each scanning location can be directly computed with the aid of the 2D K-domain transform algorithm and multi-slice imaging may be accomplished by sequentially scanning the sample through the light sheet. Since the K-domain transform method operates in transmission geometry, rotation of the sample or illumination is not necessary, data acquisition is quick, and mechanical precision of the optical setup and environmental stability requirements are significantly reduced. The suggested method has significant advantages for applications with short wavelengths, such as coherent synchrotron radiation and high-energy electron beams, where reflection is often absent. The feasibility of this proposed method is verified numerically and experimentally.

Intravenous Smart Pumps at the Point of Care: A Descriptive, Observational Study.

ObjectiveThis study was conducted to advance understanding of intravenous (IV) smart pump medication administration practices using the Baxter Spectrum IQ. The primary objective was to observe adherence with manufacturer required IV smart pump system setup at the point of care during actual clinical use.MethodsThe study was conducted in a 285-bed acute care community hospital near Boston, Massachusetts. The study design was observational and noninterventional, and all data were collected by a single observer. Observations included measurement and documentation of adherence with the Baxter Spectrum IQ system setup requirements.ResultsA total of 200 primary and secondary IV medication administration observations were included: 101 in critical care and 99 in medical-surgical. Overall adherence was found to be: 6.5% with IV smart pump position relative to the patient (aim 1); 6.5% with required position of the primary infusion bag (aim 2); and 69.5% adherence with required position of the secondary medication infusion bag (aim 3). Additional exploratory data were also collected.ConclusionsThese results add to the emerging body of knowledge, which support that adherence to required system setup for head-height dependent IV smart pumps is low and difficult to achieve during actual clinical use. Consideration of alternative human factors–designed technology to replace the current manual setup requirements is needed to improve the process of acute care IV medication administration in this very important area of patient safety.

Development of a miniaturized robotic guidance device for stereotactic neurosurgery.

Consistently high accuracy and a straightforward use of stereotactic guidance systems are crucial for precise stereotactic targeting and a short procedural duration. Although robotic guidance systems are widely used, currently available systems do not fully meet the requirements for a stereotactic guidance system that combines the advantages of frameless surgery and robotic technology. The authors developed and optimized a small-scale yet highly accurate guidance system that can be seamlessly integrated into an existing operating room (OR) setup due to its design. The aim of this clinical study is to outline the development of this miniature robotic guidance system and present the authors' clinical experience. After extensive preclinical testing of the robotic stereotactic guidance system, adaptations were implemented for robot fixation, software usability, navigation integration, and end-effector application. Development of the robotic system was then advanced in a clinical series of 150 patients between 2013 and 2019, including 111 needle biopsies, 13 catheter placements, and 26 stereoelectroencephalography (SEEG) electrode placements. During the clinical trial, constant modifications were implemented to meet the setup requirements, technical specifications, and workflow for each indication. For each application, specific setup, workflow, and median procedural accuracy were evaluated. Application of the miniature robotic system was feasible in 149 of 150 cases. The setup in each procedure was successfully implemented without adding significant OR time. The workflow was seamlessly integrated into the preexisting procedure. In the course of the study, procedural accuracy was improved. For the biopsy procedure, the real target error (RTE) was reduced from a mean of 1.8 ± 1.03 mm to 1.6 ± 0.82 mm at entry (p = 0.05), and from 1.7 ± 1.12 mm to 1.6 ± 0.72 mm at target (p = 0.04). For the SEEG procedures, the RTE was reduced from a mean of 1.43 ± 0.78 mm in the first half of the procedures to 1.12 ± 0.52 mm (p = 0.002) at entry in the second half, and from 1.82 ± 1.13 mm to 1.57 ± 0.98 mm (p = 0.069) at target, respectively. No healing complications or infections were observed in any case. The miniature robotic guidance device was able to prove its versatility and seamless integration into preexisting workflow by successful application in 149 stereotactic procedures. According to these data, the robot could significantly improve accuracy without adding time expenditure.

Physiologically Based Pharmacokinetics Modeling in Biopharmaceutics: Case Studies for Establishing the Bioequivalence Safe Space for Innovator and Generic Drugs.

For successful oral drug development, defining a bioequivalence (BE) safe space is critical for the identification of newer bioequivalent formulations or for setting of clinically relevant in vitro specifications to ensure drug product quality. By definition, the safe space delineates the dissolution profile boundaries or other drug product quality attributes, within which the drug product variants are anticipated to be bioequivalent. Defining a BE safe space with physiologically based biopharmaceutics model (PBBM) allows the establishment of mechanistic in vitro and in vivo relationships (IVIVR) to better understand absorption mechanism and critical bioavailability attributes (CBA). Detailed case studies on how to use PBBM to establish a BE safe space for both innovator and generic drugs are described. New case studies and literature examples demonstrate BE safe space applications such as how to set in vitro dissolution/particle size distribution (PSD) specifications, widen dissolution specification to supersede f2 tests, or application toward a scale-up and post-approval changes (SUPAC) biowaiver. A workflow for detailed PBBM set-up and common clinical study data requirements to establish the safe space and knowledge space are discussed. Approaches to model in vitro dissolution profiles i.e. the diffusion layer model (DLM), Takano and Johnson models or the fitted PSD and Weibull function are described with a decision tree. The conduct of parameter sensitivity analyses on kinetic dissolution parameters for safe space and virtual bioequivalence (VBE) modeling for innovator and generic drugs are shared. The necessity for biopredictive dissolution method development and challenges with PBBM development and acceptance criteria are described.