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Articles 271 - 300 of 1011

Full-Text Articles in Operations Research, Systems Engineering and Industrial Engineering

Evaluating Transaction Pairing Strategies For Vehicle-Based High-Density Storage Systems, Debjit Roy, Harit Joshie Jan 2016

Evaluating Transaction Pairing Strategies For Vehicle-Based High-Density Storage Systems, Debjit Roy, Harit Joshie

14th IMHRC Proceedings (Karlsruhe, Germany – 2016)

Vehicle-based storage and retrieval systems present an attractive choice for distribution center automation because it provides the flexibility in managing demand fluctuations without affecting transaction throughput times. In this research, we contend that while dual-command cycles can reduce the vehicle travel times for processing transactions, it may not be the best policy for reducing transaction throughput times when transactions arrive at random time instants. We develop stochastic models to test the transaction throughput time performance with multiple pairing strategies and present operational insights.


New Design Guidelines For In-Plant Milk-Run Systems, Thorsten Schmidt, Ingolf Meinhardt, Frank Schulze Jan 2016

New Design Guidelines For In-Plant Milk-Run Systems, Thorsten Schmidt, Ingolf Meinhardt, Frank Schulze

14th IMHRC Proceedings (Karlsruhe, Germany – 2016)

Tugger trains became a popular means of supply in material handling intensive production systems. In contrast to forklift trucks they interlink a supermarket with multiple delivery locations along a transport route in a milk-run. But the efficiency gain (higher transport capacity, reduced labor costs) has its price: Compared to forklift trucks, planning and dimensioning of in-plant milk-run systems is more complicated. The paper discusses features and drawbacks of a recent standardization approach of the Association of German Engineers (VDI) and highlights the variety of technical restrictions which have to be considered when a milkrun system is designed. It shows, that …


A Heuristic Approach To Storage System Design With Simultaneous Assignment Of Goods, Tobias Staab, Willibad A. Gunthner Jan 2016

A Heuristic Approach To Storage System Design With Simultaneous Assignment Of Goods, Tobias Staab, Willibad A. Gunthner

14th IMHRC Proceedings (Karlsruhe, Germany – 2016)

In the paper at hand, we analyze the planning of manually operated storage systems consisting of different storage areas. When solving design problems like dimensioning or equipment selection, the assignment of goods to storage areas has to be considered. Based on a general model to describe the geometry and performance calculation of a warehouse, we present a heuristic approach to assign goods to storage areas while simultaneously determining the design of the storage areas in a way that generates the lowest running costs. Our approach aims to support planners during the rough planning stage by providing a quick overview of …


The Storage Replenishment Problem In Rectangular Warehouses, Haldun Sural, Claudia Archetti, Melih Celik Jan 2016

The Storage Replenishment Problem In Rectangular Warehouses, Haldun Sural, Claudia Archetti, Melih Celik

14th IMHRC Proceedings (Karlsruhe, Germany – 2016)

In warehouses, storage replenishment operations involve the transportation of items to capacitated item slots in forward storage area from reserve storage. These items are later picked from these slots as their demand arises. While order picking constitutes the majority of warehouse operating costs, replenishment operations might be as costly in warehouses where pick lists generally consist of only a few lines (e.g., order fulfillment warehouses). In this study, we consider the storage replenishment problem in a parallel-aisle warehouse, where replenishment and order picking operations are carried out in successive waves with time limits. The aim is to determine the item …


A Lagrangian Relaxation For Capacitated Single Allocation P-Hub Median Problem With Multiple Capacity Levels, Ching-Jung Ting, Kuo-Rui Lu Jan 2016

A Lagrangian Relaxation For Capacitated Single Allocation P-Hub Median Problem With Multiple Capacity Levels, Ching-Jung Ting, Kuo-Rui Lu

14th IMHRC Proceedings (Karlsruhe, Germany – 2016)

In this paper we consider a capacitated single allocation p-hub median problem with multiple capacity levels (CSApHMPMC) in which the decisions are to determine the location of p hubs and their capacity levels, the single allocation of non-hub nodes to hubs in the logistics network. This problem is formulated as an integer programming model with the objective of minimizing the sum of total transportation cost and fixed cost of the selected p hubs with established capacity levels. A Lagrangian relaxation (LR) approach is proposed to solve the CSApHMPMC. The Lagrangian function that we formulated decomposed the original problem into smaller …


Monte Carlo Algorithm To Study Performance Parameters Of Shuttle Systems, Wolfgang Trummer, Dirk Jodin Jan 2016

Monte Carlo Algorithm To Study Performance Parameters Of Shuttle Systems, Wolfgang Trummer, Dirk Jodin

14th IMHRC Proceedings (Karlsruhe, Germany – 2016)

Shuttle systems provide alternative solutions in storage technology. Ma-terial flow analyses of these systems are extensive due to complex interac-tion of several shuttles and lift elements. Besides classic cycle time calcu-lation, it also requires advanced analyzing methods. At the Institute of Logistics Engineering (ITL), Graz University of Technology, an innovative, software-based approach has been developed to investigate the performance of shuttle systems. This approach is based on the Monte Carlo method. The software tool takes into account a variety of different systems and operating parameters to reflect operative behavior of shuttle systems.


Maritime Location Decisions For Lng Bunkering Facilities, Reinier C. Schneider, Iris F.A. Vis Jan 2016

Maritime Location Decisions For Lng Bunkering Facilities, Reinier C. Schneider, Iris F.A. Vis

14th IMHRC Proceedings (Karlsruhe, Germany – 2016)

Liquefied natural gas (LNG) is one of the upcoming fuels to be used for more sustainable shipping activities in the maritime sector. For a widespread adoption by end-users, a refuelling network requiring capital intensive investments, needs to be in place. From a macro perspective of suppliers of LNG, it makes sense to develop the infrastructure at strategic locations that capture as many vessels and ships as possible. The goal of this research is to develop a facility location model that can contribute to the location selection of LNG facilities in a new fuelling network. The new model will fit the …


Intermodal Hubs In The Physical Internet, Nadeepa Wickramage, Bill Ferrell Jan 2016

Intermodal Hubs In The Physical Internet, Nadeepa Wickramage, Bill Ferrell

14th IMHRC Proceedings (Karlsruhe, Germany – 2016)

Distribution of finished goods is currently an effective but inefficient process that consumes significant quantities of fossil fuel to move empty assets. This results in increased costs that are passed to the consumer and unnecessarily increased carbon emissions. The Physical Internet (PI) is focused on shared logistics that could prove to be an important element of next-generation logistics systems. The idea is to store and transport goods in anonymous standard-sized containers so that transportation and warehousing can be efficiently shared by many companies including competitors. If implemented, this idea has the potential of dramatically increasing efficiency thereby reducing fuel consumption …


Analyzing Order Throughput Times In A Milkrun Picking System, J. P. Van Der Gaast, M.B. M. De Koster, Ivo J.B.F. Adan Jan 2016

Analyzing Order Throughput Times In A Milkrun Picking System, J. P. Van Der Gaast, M.B. M. De Koster, Ivo J.B.F. Adan

14th IMHRC Proceedings (Karlsruhe, Germany – 2016)

E-commerce fulfillment competition evolves around cheap, speedy, and time-definite delivery. Milkrun order picking systems have proven to be very successful in providing handling speed for a large, but highly variable, number of orders. In this system, an order picker picks orders that arrive in real time during the picking process; by dynamically changing the stops on the picker’s current picking route. The advantage of milkrun picking is that it reduces order picking set-up time and worker travel time compared to conventional batch picking systems. This paper is the first in studying order throughput times of multi-line orders in a milkrun …


Hand-Grasping And Finger Tapping Induced Similar Functional Near-Infrared Spectroscopy Cortical Responses, Nasser H. Kashou, Brenna M. Giacherio, Ramzi W. Nahhas, Sudarshan R. Jadcherla Jan 2016

Hand-Grasping And Finger Tapping Induced Similar Functional Near-Infrared Spectroscopy Cortical Responses, Nasser H. Kashou, Brenna M. Giacherio, Ramzi W. Nahhas, Sudarshan R. Jadcherla

Biomedical, Industrial & Human Factors Engineering Faculty Publications

Despite promising advantages such as low cost and portability of functional near-infrared spectroscopy (fNIRS), it has yet to be widely implemented outside of basic research. Specifically, fNIRS has yet to be proven as a standalone tool within a clinical setting. The objective of this study was to assess hemodynamic concentration changes at the primary and premotor motor cortices as a result of simple whole-hand grasping and sequential finger-opposition (tapping) tasks. These tasks were repeated over 3 days in a randomized manner. Ten healthy young adults (23.8 4.8 years) participated in the study. Quantitatively, no statistically significant differences were discovered between …


Finite Element Analysis Of Superior C3 Cervical Vertebra Endplate And Cancellous Core Under Static Loads, Isaac Mabe, Tarun Goswami Jan 2016

Finite Element Analysis Of Superior C3 Cervical Vertebra Endplate And Cancellous Core Under Static Loads, Isaac Mabe, Tarun Goswami

Biomedical, Industrial & Human Factors Engineering Faculty Publications

Subsidence is a type of failure associated with implanted cervical cages or artificial intervertebral discs. It is defined as a loss of postoperative disc height. Actuarial rates show a risk of subsidence at 16 weeks at 70.7 percent. This study examines the changes in the vertebral endplate morphology and the resulting effect on the stresses developed in the endplate and in the vertebral core. A three-dimensional linear elastic model was created from computed tomographic (CT) scans and material properties were assigned according to various studies. Particular care was taken in the superior endplate that was modeled according to experimental measurements. …


A Performance Measurement Framework And Solution Approach For The Integrated Facility Layout Problem With Uncertain Demand, Melih Celik, Begun Efeoglu, Haldun Sural Jan 2016

A Performance Measurement Framework And Solution Approach For The Integrated Facility Layout Problem With Uncertain Demand, Melih Celik, Begun Efeoglu, Haldun Sural

14th IMHRC Proceedings (Karlsruhe, Germany – 2016)

The integrated facility layout problem (IFLP) focuses on the simultaneous determination of the relative locations of multiple copies of capacitated equip- ment or machinery in a facility, as well as the material ow between these units. In this paper, we consider the IFLP in the existence of uncertain demand for the products of the facility. Motivated by the framework for next generation facility layouts by Benjaafar et al. (2002), we extend the approaches in the lit- erature for distributed facility layouts to the case of dynamic demand and the possibility of relayouts, and propose a heuristic solution approach to minimize …


Determination Of Cycle Times For Double Deep Storage Systems Using A Dual Capacity Handling Device, Katharina Dorr Jan 2016

Determination Of Cycle Times For Double Deep Storage Systems Using A Dual Capacity Handling Device, Katharina Dorr

14th IMHRC Proceedings (Karlsruhe, Germany – 2016)

Double deep storage is an efficient method to improve space utilization in warehouses. Contrary to intuition, it also can be efficient when considering retrieval times, since the aisles of a warehouse with double deep storage may be shorter than comparable warehouses with single deep storage. AS/RS-machines equipped with two load-handling units might further improve the situation, since two storage units (for instance pallets or cases) can be stored and retrieved, effectively allowing quadruple command cycles, bringing in total two storage units into the aisle and retrieving two storage units at the same time. In this paper, we present a method …


Operational-Level Optimization Of Inbound Intralogistics, Hector J. Carlo, Yeiram Martinez Jan 2016

Operational-Level Optimization Of Inbound Intralogistics, Hector J. Carlo, Yeiram Martinez

14th IMHRC Proceedings (Karlsruhe, Germany – 2016)

This study is concerned with optimizing inbound operations at distribution centers (DCs), warehouses, and cross-docks with staging areas. The objective of the problem is to minimize the makespan required to move all unit loads from the trailers to the flow racks, and from the flow racks to their respective storage locations. It is assumed that a set of inbound trailers with known composition have been assigned and sequenced to inbound dock doors. The following three inbound logistics decisions are simultaneously considered: i) unloaders’ assignment and scheduling, ii) loads-to-flow rack assignment, and iii) assignment and haulers’ scheduling. In this study we …


Methodology For Choosing An Appropriate Inland Vessels As A Floating Distribution Centers, Andrea Seidlova, David Sourek Jan 2016

Methodology For Choosing An Appropriate Inland Vessels As A Floating Distribution Centers, Andrea Seidlova, David Sourek

14th IMHRC Proceedings (Karlsruhe, Germany – 2016)

The primary goal of this paper is to propose a methodology for the choice of an appropriate vessel type under the specific condition of floating distribution center. The right choice of the appropriate type of vessel has a fundamental influence on the long-term success of city logistic projects with water transport. In this paper, we propose a methodology for vessel choice according to its inner layout and technology of handling. The possibility of an application in practice will be defined for each option.


The Reconfigurable Machinery Efficient Workspace Analysis Based On The Twist Angles, Ana M. Djuric, Vukica Jovanovic, Mirjana Filipovic, Ljubinko Kevac Jan 2016

The Reconfigurable Machinery Efficient Workspace Analysis Based On The Twist Angles, Ana M. Djuric, Vukica Jovanovic, Mirjana Filipovic, Ljubinko Kevac

Engineering Technology Faculty Publications

A novel methodology for the calculation, visualisation and analysis of the Reconfigurable Machinery Efficient Workspace (RMEW), based on the twist angles, is presented in this paper. The machinery's kinematic parameters are used for calculating the workspace, while the efficient workspace is associated with the machinery's path and includes the end-effector position and orientation. To analyse and visualise many different machinery efficient workspaces at the same time, the calculation is based on the previously developed and validated complex reconfigurable machinery's kinematic structure named n-DOF Global Kinematic Model (n-GKM). An industrial robot is used as an example to demonstrate …


Applications Of Digital Manufacturing In Manufacturing Process Support, Vukica Jovanovic, Mihael Debevec, Niko Herakovic, Alok Verma, Mileta Tomovic Jan 2016

Applications Of Digital Manufacturing In Manufacturing Process Support, Vukica Jovanovic, Mihael Debevec, Niko Herakovic, Alok Verma, Mileta Tomovic

Engineering Technology Faculty Publications

In this study, the authors developed three new approaches and models for improvements related to manufacturing processes. The main focus was on planning in a digital environment before the actual manufacturing process is carried out. The first approach is digital manufacturing, which gives affords the opportunity for performing an entire manufacturing process in a virtual environment. In this way, engineers virtually define, plan, create, monitor, and control all production processes. The planning phase can be done simultaneously, while other manufacturing processes are already in place. In this way, processes can continue with no interruption. Various product lifecycle management tools have …


Simulation-Based Energy And Cycle Time Analysis Of Shuttle-Based Storage And Retrieval System, Tone Lerher, Banu Yetkin Ekren, Anil Akpunar Jan 2016

Simulation-Based Energy And Cycle Time Analysis Of Shuttle-Based Storage And Retrieval System, Tone Lerher, Banu Yetkin Ekren, Anil Akpunar

14th IMHRC Proceedings (Karlsruhe, Germany – 2016)

This study explores the best warehouse design for shuttle-based storage and retrieval system (SBS/RS) minimizing average energy consumption per transaction and average cycle time per transaction, simultaneously. For that we provided average energy consumption per transaction versus average cycle time per transaction graphs, for different design scenarios of the studied SBS/RS warehouse. In the design concept, we considered, rack design in terms of number of bays, number of tiers, number of aisles, as well as velocity profiles of lifts in the system. We completed 144 number of experiments by simulation to see the trade-offs based on the design scenarios and …


Integrated Versus Sequential Scheduling And Assignment At A Unit Load Cross-Dock, Arpan Rijal, Marco Bijvank, Rene De Koster Jan 2016

Integrated Versus Sequential Scheduling And Assignment At A Unit Load Cross-Dock, Arpan Rijal, Marco Bijvank, Rene De Koster

14th IMHRC Proceedings (Karlsruhe, Germany – 2016)

Within a cross-dock, the assignment of trucks to dock-doors and the scheduling of trucks to be processed are two major operational decisions. Conventionally, assignment and scheduling decisions are made sequentially. However, solving the two problems sequentially can lead to sub-optimal solutions because the objectives of the two problems are in conflict with each other. To gain further insights, we create an integrated model which is capable of simultaneously scheduling and assigning trucks at cross-docks. We contrast the integrated model with a sequential model which first schedules trucks for processing and then assigns them to dock-doors. Experiments demonstrate that the integrated …


Group Scheduling In A Cellular Manufacturing Shop To Minimise Total Tardiness And Nt: A Comparative Genetic Algorithm And Mathematical Modelling Approach, Gokhan Egilmez, Emre M. Mese, Bulent Erenay, Gürsel A. Süer Jan 2016

Group Scheduling In A Cellular Manufacturing Shop To Minimise Total Tardiness And Nt: A Comparative Genetic Algorithm And Mathematical Modelling Approach, Gokhan Egilmez, Emre M. Mese, Bulent Erenay, Gürsel A. Süer

Mechanical and Industrial Engineering Faculty Publications

In this paper, family and job scheduling in a cellular manufacturing shop is addressed where jobs have individual due dates. The objectives are to minimise total tardiness and the number of tardy jobs. Family splitting among cells is allowed but job splitting is not. Two optimisation methods are employed in order to solve this problem, namely mathematical modelling (MM) and genetic algorithm (GA). The results showed that GA found the optimal solution for most of the problems with high frequency. Furthermore, the proposed GA is efficient compared to the MM especially for larger problems in terms of execution times. Other …


Parametric Investigations Into Internal Surface Modification Of Brass Tubes With Alternating Magnetic Field, Harish Kumar, Sehijpal Singh, Anil K. Srivastava Jan 2016

Parametric Investigations Into Internal Surface Modification Of Brass Tubes With Alternating Magnetic Field, Harish Kumar, Sehijpal Singh, Anil K. Srivastava

Manufacturing & Industrial Engineering Faculty Publications and Presentations

The final finish operations have great significance in an overall manufacturing cycle of a product. The surface finishing and modification of surfaces have been the vital requirements of most of the products. The processes like shot peening, shot blasting, abrasive finishing and super finishing are being largely employed for such requirements. While final finishing of flat and outside surfaces are relatively easy and well established, the internal surfaces such as those of pipes is not so simple. In this paper, the application of low frequency alternative magnetic field has been explored for imparting surface modification including surface on the internal …


Period Batch Control - A Production Planning System Applied To Virtual Manufacturing Cells, Z. Tesic, B. Stevanaov, V. Jovanovic, M. Tomic, C. Kafol Jan 2016

Period Batch Control - A Production Planning System Applied To Virtual Manufacturing Cells, Z. Tesic, B. Stevanaov, V. Jovanovic, M. Tomic, C. Kafol

Engineering Technology Faculty Publications

Period Batch Control (PBC) system has been known for its implementation with the classical group technology (GT) cells, and it has been known for its simplicity. The main production planning decisions concern the choice of the period length and the stage number and contents. Also, in order to better integrate the production planning with the application of GT cells at the shop floor, the concept of virtual manufacturing cells has been applied. Since virtual cells configurations are changing periodically, a model for implementing the PBC system into virtual manufacturing cells environment is developed. The model enables alignment of the PBC …


Pilot Programs For Veterans Transition To Engineering Fields, Vukica M. Jovanovic, Anthony W. Dean, Carol L. Considine, Karina Arcaute, Petros Katsioloudis, Mileta Tomovic, Thomas B. Stout, Connor Schwalm, Jennifer G. Michaeli, Yuzhong Shen Jan 2016

Pilot Programs For Veterans Transition To Engineering Fields, Vukica M. Jovanovic, Anthony W. Dean, Carol L. Considine, Karina Arcaute, Petros Katsioloudis, Mileta Tomovic, Thomas B. Stout, Connor Schwalm, Jennifer G. Michaeli, Yuzhong Shen

Engineering Technology Faculty Publications

Veterans, through their active service, frequently receive training in highly skilled technical areas. However, they may lack a theoretical background in underlying engineering principles. They also need additional support with the transition from a highly structured military environment to an environment with more ambiguous time constraints and different sorts of responsibilities. Moreover they are facing challenges which are specific for their student population. Therefore, enabling multiple mechanisms which would support them and provide them necessary guidance are especially important at universities with large veteran populations such as at Old Dominion University in Norfolk, Virginia. Hence, there is a need for …


Ergonomic Analysis Of Mobile Cart–Assisted Stocking Activities Using Electromyography, Sohyung Cho Dec 2015

Ergonomic Analysis Of Mobile Cart–Assisted Stocking Activities Using Electromyography, Sohyung Cho

SIUE Faculty Research, Scholarship, and Creative Activity

Workers in grocery stores are exposed to numerous musculoskeletal risks that can be reduced using assistive devices while performing stocking tasks. A regional grocery store has recently deployed a mobile cart without comprehension of its ergonomic impact on workers, which this article investigates using normalized electromyography data (%MVC). This article studies not only ergonomic impact based on %MVC values but also work performance represented by a muscle force metric (MFM). The results from this study showed highest muscle groups in %MVC and MFM were the erector spinae and triceps. Interestingly, muscle activations on erector spinae were reduced when mobile cart …


On Valuing Biopharmaceutical Product Pipelines: An Effectuation Model And Evidence, Mark J. Ahn, Anne S. York, Wei Wu, Yulianto Suharto, Tugrul Unsal Daim Dec 2015

On Valuing Biopharmaceutical Product Pipelines: An Effectuation Model And Evidence, Mark J. Ahn, Anne S. York, Wei Wu, Yulianto Suharto, Tugrul Unsal Daim

Engineering and Technology Management Faculty Publications and Presentations

New creative approaches are needed to manage emerging biotechnology innovations, regulations, and payor environments to enhance product pipeline productivity, valuation, and risk management. Biopharmaceutical firms must make dynamic resource allocation decisions on their relative levels of internal R&D and external strategic alliances in furthering their pipelines. As the predominant method of using discounted cash flow (DCF) methodologies may lead to chronic underinvestment and performance, we evaluated the integration of traditional DCF with an effectuation model of analysis. Unlike traditional financial models that begin with the end goal of assumed known cash flows and recursively solve for portfolio optimization, the effectuation …


The Prediction Predicament, William "Ike" Eisenhauer Dec 2015

The Prediction Predicament, William "Ike" Eisenhauer

Engineering and Technology Management Faculty Publications and Presentations

The article focuses on the prediction of predicament in terms of forecasting at industrial engineering level. Topics discussed include business optimize resources via forecasting; audience who cannot comprehend the methodology used for forecasting in healthcare operations; and use of forecasting for performance measurement.


Analysis Of A Clinically Failed, Mechanically Intact, Reconstructive Compression Plate, Bharadwaj Cheruvu, Sunil Karmacharya, Richard T. Laughlin, Tarun Goswami Sep 2015

Analysis Of A Clinically Failed, Mechanically Intact, Reconstructive Compression Plate, Bharadwaj Cheruvu, Sunil Karmacharya, Richard T. Laughlin, Tarun Goswami

Biomedical, Industrial & Human Factors Engineering Faculty Publications

A reconstructive orthopedic bone plate was submitted for analysis. Traditional failure analysis methods were used to assess the mode of the plate failure. Metallographic investigation of the plate was carried out in this report. Since limited data was available in the literature and clinical data related to subject demography, date of removal as well as reasons for removal unknown, in depth analysis was not possible. However, the plate was received in in-tact condition with minor biological deposits and scratches, it is speculated that the failure of the plate may have been due to biological/clinical reasons, likely infection, rejecting the device …


Haptics-Based Cataract Surgery Simulator, Jia Luo Sep 2015

Haptics-Based Cataract Surgery Simulator, Jia Luo

Link Foundation Modeling, Simulation and Training Fellowship Reports

Surgical training using computer-based simulators are being adopted by many medical specialties, mainly because they offer several advantages to traditional training methods involving animals or cadavers. This article focuses on the design and implementation of a haptics-based cataract surgery simulator.


The Time Has Come For Nursing Engineering, William "Ike" Eisenhauer Aug 2015

The Time Has Come For Nursing Engineering, William "Ike" Eisenhauer

Engineering and Technology Management Faculty Publications and Presentations

The article discusses the need for healthcare and educational organizations to create nursing engineering program. Topics discussed include successes in healthcare systems as engineers and healthcare professionals, integration of industrial engineering or lean and Six Sigma courses into nursing programs of the University of Alabama and modern healthcare system and modern healthcare participants that can be addressed by the new profession.


Velaglucerase Alfa (Vpriv) Enzyme Replacement Therapy In Patients With Gaucher Disease: Long-Term Data From Phase Iii Clinical Trials, Derralynn A. Hughes, Derlis Gonzalez, Elena A. Lukina, Atul Mehta, Madhulika Kabra, Deborah Elstein, Isaac Kisinovsky, Pilar Giraldo, Ashish Bavdekar, Thomas N. Hangartner, Nan Wang, Eric Crombez, Ari Zimran Jul 2015

Velaglucerase Alfa (Vpriv) Enzyme Replacement Therapy In Patients With Gaucher Disease: Long-Term Data From Phase Iii Clinical Trials, Derralynn A. Hughes, Derlis Gonzalez, Elena A. Lukina, Atul Mehta, Madhulika Kabra, Deborah Elstein, Isaac Kisinovsky, Pilar Giraldo, Ashish Bavdekar, Thomas N. Hangartner, Nan Wang, Eric Crombez, Ari Zimran

Biomedical, Industrial & Human Factors Engineering Faculty Publications

Type 1 Gaucher disease is an inherited lysosomal enzyme deficiency with variable age of symptom onset. Common presenting signs include thrombocytopenia, anemia, hepatosplenomegaly, bone abnormalities, and, additionally in children, growth failure. Fifty-seven patients aged 3–62 years at the baseline of two phase III trials for velaglucerase alfa treatment were enrolled in the single extension study. In the extension, they received every-other-week velaglucerase alfa intravenous infusions for 1.2–4.8 years at 60 U/kg, although 10 patients experienced dose reduction. No patient experienced a drug-related serious adverse event or withdrew due to an adverse event. One patient died following a convulsion that was …