Application of the QbD Principles in the Development of the Casopitant Mesylate Manufacturing Process. Process Research Studies for the Definition of the Control Strategy of some Drug Substance-CQAs for Stages 2a, 2b, and 2c

2010 ◽  
Vol 14 (4) ◽  
pp. 805-814 ◽  
Author(s):  
Zadeo Cimarosti ◽  
Fernando Bravo ◽  
Damiano Castoldi ◽  
Francesco Tinazzi ◽  
Stefano Provera ◽  
...  
Keyword(s):  
Control Strategy ◽  
Manufacturing Process ◽  
Process Research ◽  
Drug Substance ◽  
Definition Of ◽  
Research Studies

Proteomics of Human Milk: Definition of a Discovery Workflow for Clinical Research Studies

2021 ◽  
Author(s):  
Loïc Dayon ◽  
Charlotte Macron ◽  
Sabine Lahrichi ◽  
Antonio Núñez Galindo ◽  
Michael Affolter
Keyword(s):  
Human Milk ◽  
Clinical Research ◽  
Definition Of ◽  
Research Studies

scholarly journals Getting to Hope: Perspectives from Patients and Caregivers Living with Chronic Childhood Illness

Children ◽  
2021 ◽  
Vol 8 (6) ◽  
pp. 525
Author(s):  
Emily von Scheven ◽  
Bhupinder K. Nahal ◽  
Rosa Kelekian ◽  
Christina Frenzel ◽  
Victoria Vanderpoel ◽  
...  
Keyword(s):  
Conceptual Model ◽  
Research Question ◽  
Young Patients ◽  
Future Research ◽  
Childhood Onset ◽  
Virtual Focus Groups ◽  
Definition Of ◽  
Selection Of ◽  
Chronic Childhood ◽  
Research Studies

Promoting hope was identified in our prior work as the top priority research question among patients and caregivers with diverse childhood-onset chronic conditions. Here, we aimed to construct a conceptual model to guide future research studies of interventions to improve hope. We conducted eight monthly virtual focus groups and one virtual workshop with patients, caregivers, and researchers to explore key constructs to inform the model. Discussions were facilitated by Patient Co-Investigators. Participants developed a definition of hope and identified promotors and inhibitors that influence the experience of hope. We utilized qualitative methods to analyze findings and organize the promotors and inhibitors of hope within three strata of the socio-ecologic framework: structural, interpersonal, and intrapersonal. Participants identified three types of interventions to promote hope: resources, navigation, and activities to promote social connection. The hope conceptual model can be used to inform the selection of interventions to assess in future research studies aimed at improving hope and the specification of outcome measures to include in hope research studies. Inclusion of the health care system in the model provides direction for identifying strategies for improving the system and places responsibility on the system to do better to promote hope among young patients with chronic illness and their caregivers.

scholarly journals Fuzzy Control Model and Simulation for Nonlinear Supply Chain System with Lead Times

Complexity ◽  
2017 ◽  
Vol 2017 ◽  
pp. 1-11 ◽  
Author(s):  
Songtao Zhang ◽  
Yanting Hou ◽  
Siqi Zhang ◽  
Min Zhang
Keyword(s):  
Supply Chain ◽  
Fuzzy Control ◽  
Control Strategy ◽  
Control Model ◽  
Lead Times ◽  
Supply Chain System ◽  
Chain System ◽  
Model And Simulation ◽  
Definition Of ◽  
System Variables

A new fuzzy robust control strategy for the nonlinear supply chain system in the presence of lead times is proposed. Based on Takagi-Sugeno fuzzy control system, the fuzzy control model of the nonlinear supply chain system with lead times is constructed. Additionally, we design a fuzzy robust H∞ control strategy taking the definition of maximal overlapped-rules group into consideration to restrain the impacts such as those caused by lead times, switching actions among submodels, and customers’ stochastic demands. This control strategy can not only guarantee that the nonlinear supply chain system is robustly asymptotically stable but also realize soft switching among subsystems of the nonlinear supply chain to make the less fluctuation of the system variables by introducing the membership function of fuzzy system. The comparisons between the proposed fuzzy robust H∞ control strategy and the robust H∞ control strategy are finally illustrated through numerical simulations on a two-stage nonlinear supply chain with lead times.

A Temporal Process Specification Language for Virtual Manufacturing Engineering

1998 ◽  
Author(s):  
David E. Lee ◽  
H. Thomas Hahn
Keyword(s):  
Manufacturing Process ◽  
Specification Language ◽  
Virtual Manufacturing ◽  
Process Definition ◽  
Virtual Factory ◽  
Process Specification ◽  
Temporal Relationships ◽  
Temporal Process ◽  
Definition Of ◽  
Virtual Process

Abstract A process specification language is being developed for virtual manufacturing that provides a structured portable definition of a given manufacturing process as well as the ability to specify the temporal relationships between individual operation steps that compose a process. Based on the concepts embodied in markup languages such as HTML, SGML and XML, a portable process definition structure is defined. This structure provides a template from which virtual process specifications can be created. Subsequently, these structures can be exchanged between development environments for virtual process engineering and the actualized manufacturing facilities where processes are implemented. In addition, dependencies in time between the operation steps of a process such as common start times and operation serialization can be represented to allow for a complete specification of temporal behavior of a given manufacturing process. By providing this explicit mechanism for representing temporal constraints, a virtual manufacturing process can be viewed and utilized both in a localized application on a single virtual factory floor as well as distributed across multiple, interlinked virtual environments.

scholarly journals Stress Factors in mAb Drug Substance Production Processes: Critical Assessment of Impact on Product Quality and Control Strategy

2020 ◽  
Vol 109 (1) ◽  
pp. 116-133 ◽  
Author(s):  
Tapan K. Das ◽  
Linda O. Narhi ◽  
Alavattam Sreedhara ◽  
Tim Menzen ◽  
Christoph Grapentin ◽  
...  
Keyword(s):  
Product Quality ◽  
Control Strategy ◽  
Critical Assessment ◽  
Drug Substance ◽  
Stress Factors ◽  
Production Processes ◽  
And Control

Simulation Research on Influence of SVC Switching Overvoltage on Phase Controlled Reactor

2014 ◽  
Vol 602-605 ◽  
pp. 2966-2969
Author(s):  
Jun Min Li ◽  
Jiang Tao Li ◽  
Xin Yu ◽  
Shu Han Wang ◽  
Si Cong Wu
Keyword(s):  
Control Strategy ◽  
Natural Environment ◽  
Manufacturing Process ◽  
Research Institutions ◽  
Low Loss ◽  
Simulation Research ◽  
Switching Overvoltage ◽  
Transformer Substation ◽  
Step Down ◽  
At Home

In recent years, 66kV vertical TCR-type SVC was put into operation in several transformer substations at home. Compared to the compensation mode of the conventional 35kV SVC which is connected to 66kV busbar through by way of step-down transformer, the vertical compensation mode has the advantages of low loss and small maintenance amount. However, it is found that damage of phase controlled reactor in TCR happens in several scenes, and the technicians and research institutions studied this problem from such aspects as phase controlled reactor manufacturing process, SVC control strategy and natural environment of the transformer substations and obtained their own conclusions. This paper uses PSCAD software to conduct a simulation research on the 66kV vertical SVC system installed on a 220kV transformer substation at home and concluded that the SVC switching overvoltage might be the direct cause leading to damage of phase controlled reactor.

scholarly journals IAPSO Standard Seawater: Definition of the Uncertainty in the Calibration Procedure, and Stability of Recent Batches

2007 ◽  
Vol 24 (10) ◽  
pp. 1785-1799 ◽  
Author(s):  
Sheldon Bacon ◽  
Fred Culkin ◽  
Nigel Higgs ◽  
Paul Ridout
Keyword(s):  
Reference Material ◽  
Potassium Chloride ◽  
Manufacturing Process ◽  
Calibration Procedure ◽  
Conductivity Ratio ◽  
Coverage Factor ◽  
Expanded Uncertainty ◽  
Significant Variability ◽  
Definition Of

Abstract Standard seawater (SSW) has been employed by oceanographers as a reference material in the determination of salinity for over a century. In all that time, this is the first study to determine the uncertainty of the SSW manufacturing process. SSW is calibrated in reference to carefully prepared solutions of potassium chloride (KCl). All uncertainties in the preparation and measurement of KCl solutions and of new SSW are calculated. The expanded uncertainty of the SSW conductivity ratio is found to be 1 × 10−5, based on a coverage factor of 2, at the time of manufacture. There is no discernible “within batch” variability. No significant variability of quality within or between batches of KCl is found. Measurement of SSW “offsets” from the label conductivity ratio as long as 5 yr after the SSW batch manufacture are reported, and no significant change in label conductivity ratio for SSW batches P130 through P144 outside the expanded uncertainty of 1 × 10−5 is found. This last result is in contrast to some other studies, and herein are suggestions as to why this may be the case.

scholarly journals What Is Intensity and How Can It Benefit Exercise Intervention in People With Stroke? A Rapid Review

2021 ◽  
Vol 2 ◽  
Author(s):  
Gavin Church ◽  
Christine Smith ◽  
Ali Ali ◽  
Karen Sage
Keyword(s):  
High Intensity ◽  
Exercise Intervention ◽  
Rapid Review ◽  
Body System ◽  
Primary Research ◽  
High Intensity Training ◽  
Definition Of ◽  
And Function ◽  
Intensity Training ◽  
Research Studies

Background: Stroke is one of the major causes of chronic physical disability in the United Kingdom, typically characterized by unilateral weakness and a loss of muscle power and movement coordination. When combined with pre-existing comorbidities such as cardiac disease and diabetes, it results in reductions in cardiovascular (CV) fitness, physical activity levels, functional capacity, and levels of independent living. High-intensity training protocols have shown promising improvements in fitness and function for people with stroke (PwS). However, it remains unclear how intensity is defined, measured, and prescribed in this population. Further, we do not know what the optimal outcome measures are to capture the benefits of intensive exercise.Aim: To understand how intensity is defined and calibrated in the stroke exercise literature to date and how the benefits of high-intensity training in PwS are measured.Methods: A rapid review of the literature was undertaken to provide an evidence synthesis that would provide more timely information for decision-making (compared with a standard systematic review). Electronic databases were searched (including Medline, PubMed, CINAHL, and Embase for studies from 2015 to 2020). These were screened by title and abstract for inclusion if they: (a) were specific to adult PwS; and (b) were high-intensity exercise interventions. Eligible studies were critically appraised using the Mixed Method Appraisal Tool (MMAT). The data extraction tool recorded the definition of intensity, methods used to measure and progress intensity within sessions, and the outcomes measure used to capture the effects of the exercise intervention.Results: Seventeen studies were selected for review, 15 primary research studies and two literature reviews. Sixteen of the 17 studies were of high quality. Nine of the primary research studies used bodyweight-supported treadmills to achieve the high-intensity training threshold, four used static exercise bikes, and two used isometric arm strengthening. Five of the primary research studies had the aim of increasing walking speed, five aimed to increase CV fitness, three aimed to improve electroencephalogram (EEG) measured cortical evoked potentials and corticospinal excitability, and two investigated any changes in muscle strength. Although only one study gave a clear definition of intensity, all studies clearly defined the high-intensity protocol used, with most (15 out of 17 studies) clearly describing threshold periods of high-intensity activity, followed by rest or active recovery periods (of varying times). All of the studies reviewed used outcomes specific to body structure and function (International Classification of Functioning, Disability, and Health (ICF) constructs), with fewer including outcomes relating to activity and only three outcomes relating to participation. The reported effect of high-intensity training on PwS was promising, however, the underlying impact on neurological, musculoskeletal, and CV systems was not clearly specified.Conclusions: There is a clear lack of definition and understanding about intensity and how thresholds of intensity in this population are used as an intervention. There is also an inconsistency about the most appropriate methods to assess and provide a training protocol based on that assessment. It remains unclear if high-intensity training impacts the desired body system, given the diverse presentation of PwS, from a neuromuscular, CV, functional, and psychosocial perspective. Future work needs to establish a clearer understanding of intensity and the impact of exercise training on multiple body systems in PwS. Further understanding into the appropriate assessment tools to enable appropriate prescription of intensity in exercise intervention is required. Outcomes need to capture measures specific not only to the body system, but also level of function and desired goals of individuals.

The electromagnetic calculations of complex motion common magnetic circuit electromagnetic converter

2014 ◽  
Vol 63 (1) ◽  
pp. 125-133
Author(s):  
Grzegorz Kamiński ◽  
Paweł Góralski
Keyword(s):  
Relative Error ◽  
Control Strategy ◽  
Quantitative Method ◽  
Magnetic Circuit ◽  
Complex Motion ◽  
Correct Operation ◽  
Rotary Mechanism ◽  
Relative Errors ◽  
Definition Of ◽  
Electromagnetic Calculations

Abstract This document contains results of research on complex motion common magnetic circuit electromagnetic converter characteristic that allows making independent axial and rotary shaft motion. The converter in addition to linear-rotary mechanism consists of two drive rotors and one common magnetic circuit excitator. Such a solution allows to reduce volume of the machine and makes it easier to use. The paper cites design intent and possible structure of the device. Phenomenon of common magnetic circuit adverse effect on correct operation of device is discussed. The concept of using relative error as a way to evaluate the influence of that phenomenon in the torques is discussed. Waveforms of determined relative errors for all possible cases is presented. Furthermore the concept of average relative error is defined and its use as a quantitative method of assessing the degree of common circuit impact is indicated. Definition of relative error ripple factor is given, and its usage is shown. Winding inductance calculation based on free FEM application is shown and its influence on control strategy and power system

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