scholarly journals Recommended Best Practices for Lyophilization Validation—2021 Part I: Process Design and Modeling

2021 ◽  
Vol 22 (7) ◽  
Author(s):  
Feroz Jameel ◽  
Alina Alexeenko ◽  
Akhilesh Bhambhani ◽  
Gregory Sacha ◽  
Tong Zhu ◽  
...  
Keyword(s):  
Process Design ◽  
Scale Up ◽  
Community Based ◽  
Process Verification ◽  
Fill Volume ◽  
Process Qualification ◽  
Batch Sizes ◽  
The Impact ◽  
The Relationship ◽  
Product Resistance

AbstractThis work describes lyophilization process validation and consists of two parts. Part I focuses on the process design and is described in the current paper, while part II is devoted to process qualification and continued process verification. The intent of these articles is to provide readers with recent updates on lyophilization validation in the light of community-based combined opinion on the process and reflect the industrial prospective. In this paper, the design space approach for process design is described in details, and examples from practice are provided. The approach shows the relationship between the process inputs; it is based on first principles and gives a thorough scientific understanding of process and product. The lyophilization process modeling and scale-up are also presented showing the impact of facility, equipment, and vial heat transfer coefficient. The case studies demonstrating the effect of batch sizes, fill volume, and dose strength to show the importance of modeling as well as the effect of controlled nucleation on product resistance are discussed.

scholarly journals Recommended Best Practices for Lyophilization Validation 2021 Part II: Process Qualification and Continued Process Verification

2021 ◽  
Vol 22 (8) ◽  
Author(s):  
Feroz Jameel ◽  
Alina Alexeenko ◽  
Akhilesh Bhambhani ◽  
Gregory Sacha ◽  
Tong Zhu ◽  
...  
Keyword(s):  
Best Practices ◽  
Process Design ◽  
Control Charts ◽  
Batch Size ◽  
Drying Time ◽  
Process Validation ◽  
Process Verification ◽  
Process Qualification ◽  
The Impact ◽  
Validation Strategy

Abstract This work describes the lyophilization process validation and consists of two parts. Part one (Part I: Process Design and Modeling) focuses on the process design and is described in the previous paper, while the current paper is devoted to process qualification and continued process verification. The goal of the study is to show the cutting edge of lyophilization validation based on the integrated community-based opinion and the industrial perspective. This study presents best practices for batch size determination and includes the effect of batch size on drying time, process parameters selection strategies, and batch size overage to compensate for losses during production. It also includes sampling strategies to demonstrate batch uniformity as well as the use of statistical models to ensure adequate sampling. Based on the LyoHUB member organizations survey, the best practices in determining the number of PPQ runs are developed including the bracketing approach with minimum and maximum loads. Standard practice around CQA and CPP selection is outlined and shows the advantages of using control charts and run charts for process trending and quality control. The case studies demonstrating the validation strategy for monoclonal antibody and the impact of the loading process on the lyophilization cycle and product quality as well as the special case of lyophilization for dual-chamber cartridge system are chosen to illustrate the process validation. The standard practices in the validation of the lyophilization process, special lyophilization processes, and their impact on the validation strategy are discussed. Graphical Abstract

scholarly journals Promoting cross-jurisdictional primary health care research: developing a set of common indicators across 12 community-based primary health care teams in Canada

2018 ◽  
Vol 20 ◽  
Author(s):  
Sabrina T. Wong ◽  
Julia M. Langton ◽  
Alan Katz ◽  
Martin Fortin ◽  
Marshall Godwin ◽  
...  
Keyword(s):  
Primary Care ◽  
Health Care ◽  
Primary Health Care ◽  
Working Group ◽  
Scale Up ◽  
Data Sources ◽  
Knowledge Generation ◽  
Community Based ◽  
Primary Health ◽  
The Impact

AbstractAimTo describe the process by which the 12 community-based primary health care (CBPHC) research teams worked together and fostered cross-jurisdictional collaboration, including collection of common indicators with the goal of using the same measures and data sources.BackgroundA pan-Canadian mechanism for common measurement of the impact of primary care innovations across Canada is lacking. The Canadian Institutes for Health Research and its partners funded 12 teams to conduct research and collaborate on development of a set of commonly collected indicators.MethodsA working group representing the 12 teams was established. They undertook an iterative process to consider existing primary care indicators identified from the literature and by stakeholders. Indicators were agreed upon with the intention of addressing three objectives across the 12 teams: (1) describing the impact of improving access to CBPHC; (2) examining the impact of alternative models of chronic disease prevention and management in CBPHC; and (3) describing the structures and context that influence the implementation, delivery, cost, and potential for scale-up of CBPHC innovations.FindingsNineteen common indicators within the core dimensions of primary care were identified: access, comprehensiveness, coordination, effectiveness, and equity. We also agreed to collect data on health care costs and utilization within each team. Data sources include surveys, health administrative data, interviews, focus groups, and case studies. Collaboration across these teams sets the foundation for a unique opportunity for new knowledge generation, over and above any knowledge developed by any one team. Keys to success are each team’s willingness to engage and commitment to working across teams, funding to support this collaboration, and distributed leadership across the working group. Reaching consensus on collection of common indicators is challenging but achievable.

The Impact of Environmental Factors on Malaria Prevalence in a Peri-Urban Community in Kwara State, Nigeria

2014 ◽  
Vol 3 (3) ◽  
pp. 173
Author(s):  
Olubunmi Ajike Mokuolu ◽  
Oluwayemisi D Adegboye ◽  
Olugbenga A Mokuolu
Keyword(s):  
Environmental Factors ◽  
Malaria Prevalence ◽  
Sampling Procedure ◽  
Multiple Regression Equation ◽  
Published Data ◽  
Community Based ◽  
The Impact ◽  
The Relationship ◽  
Selection Of ◽  
Structured Questionnaire

<p>There is a consensus on the relationship between Malaria Prevalence (MP) and Environmental Factors (EF); however, there is a dearth of published data providing this evidence in a quantifiable way. This community based study was undertaken to identify the magnitude of the relationship between MP and key environmental factors in Okelele, Ilorin East Local Government Area of Kwara State, Nigeria. A multi-staged sampling procedure was adopted for the selection of 501 children from 200 households. Children under the age of 14 years in the selected households were sampled to obtain baseline MP using malaria Rapid Diagnostic Test (mRDT) kit. Key household informant interviews and structured questionnaire were used. Relevant socio-demographic characteristics of the households, EF and non EF were determined. Acquired data was analyzed using statistical tools to determine the relationship between various independent variables and mRDT. Variables were also entered into a multiple regression equation for the generation of a mathematical model. Ethical consent was obtained from the parents before samples were taken.The study showed that EF contributed to MP in the study area.  Integrated waste management system, and regular environmental sanitation were recommended.</p>

scholarly journals Bottlenecks to Intervention Scale Up: Supply and Demand Side Perspectives From a Large, Community-based Trial of Malaria Testing

2021 ◽  
Author(s):  
Joseph Kirui ◽  
Josephine Malinga ◽  
Edna Sang ◽  
George Ambani ◽  
Lucy Abel ◽  
...  
Keyword(s):  
Community Health ◽  
Large Scale ◽  
Health Workers ◽  
Supply And Demand ◽  
Scale Up ◽  
Demand Side ◽  
Endemic Region ◽  
Community Based ◽  
The Impact ◽  
Malaria Test

Abstract Background: Maximizing the impact of community-based programs requires understanding how the supply of and demand for the intervention interact at the point of delivery. We present results from a large-scale community health worker study designed to increase the availability of and demand for malaria diagnostic testing in a rural, malaria-endemic region in western Kenya between 2015 and 2017. Methods: Community Health Workers (CHWs) provided free malaria Rapid Diagnostic Test(mRDT) in the community. Those with a positive malaria test were provided with a discounted first-line antimalarial over-the-counter. We conducted a community-based survey to collect individual study outcomes at 12- and 18-months post-implementation. In addition, we collected monthly testing data from the 244 participating CHWs and also conducted in-depth interviews with a random sample of 70 CHWs. Results: From the survey, 55% (n=948/1738) reported having a malaria test for their recent illness with 38% having been tested by a CHW. Being aware of a local CHW (95% CI:1.10-2.04) and belonging to a wealthy household (95% CI:1.14-2.06) were associated with higher malaria testing uptake from any source. Poorer households were more likely to receive a test from a CHW. School-aged children between 5-17 years were more than twice as likely to be tested by a CHW (95% CI:1.47-4.14). Both confidence in AL treatment (95% CI:1.54-4.92) and perceived accuracy of an RDT performed by a CHW (95% CI:1.12-5.27) were strongly and positively associated with testing by a CHW. In adjusted analyses, specific CHWs attributes were significantly associated with higher testing rates including formal employment (95% CI:0.05-2.70), those serving more than 50 households (95% CI:0.70-2.74) and those serving areas with a higher proportion of positive tests (95% CI:1.05, 3.22). On both the supply side and the demand side, confidence in a test performed by a CHW was strongly correlated with the success of the intervention.Conclusion: Scale-up of community-based malaria testing intervention through CHWs is feasible and effective at reaching the poorest households. In order to maximize the impact of such interventions, it is important to recognize factors that may restrict both delivery and demand for such services.

Fisheries Co-management and Fishers’ Income in Inland Openwater Fisheries in Bangladesh

2021 ◽  
Vol 8 (2) ◽  
pp. 125-149
Author(s):  
G. M. Shamsul Kabir ◽  
Golam. Mustafa
Keyword(s):  
Transaction Costs ◽  
Fisheries Management ◽  
Significant Contribution ◽  
Scale Up ◽  
Open Water ◽  
Community Management ◽  
Local Institutions ◽  
Community Based ◽  
The Impact

Abstract Community management of inland openwater fisheries in Bangladesh has introduced and practiced through the Community Based Fisheries Management (cbfm) approach with partnership arrangement of government and non-government organisations, fisher communities and other stakeholders. One of the principles behind community based fisheries management is to improve fishers’ income and reduce transaction costs efficiently. The implementation of the cbfm approach has experienced a significant contribution towards fishers’ income and transaction costs. cbfm arrangement introduced fisher led, community led and women led approach. Community based organisations (cbo s) as local institutions have been established through community participation under cbfm approach. This paper presents and assesses the impact of cbfm approaches on fishers’ income and transaction costs in inland openwater fisheries in Bangladesh. This study might have policy implication to scale up cbfm approach to promote fishers’ income for better management of inland open water fisheries with a long term commitment.

Exploring agricultural entrepreneurship and new technologies: academic and practitioners' views

2021 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Silvana Secinaro ◽  
Francesca Dal Mas ◽  
Maurizio Massaro ◽  
Davide Calandra
Keyword(s):  
Technology Acceptance ◽  
New Technologies ◽  
Scale Up ◽  
European Patent ◽  
Content Type ◽  
Theoretical Approaches ◽  
Holistic Understanding ◽  
Agricultural Entrepreneurship ◽  
The Impact ◽  
The Relationship

PurposeThis paper investigates the relationship between agricultural entrepreneurship (AE) and new technologies using academic and practitioners' perspectives to understand how new technologies such as artificial intelligence (AI), machine learning and augmented reality can promote agri-businesses.Design/methodology/approachThe paper adopts a content and thematic analysis of 325 academic sources extracted from the Scopus database and 683 patents retrieved from the European Patent Office (EPO) dataset. Additionally, the research applies the Kruskal–Wallis test as a non-parametric test for evaluating differences in the main concepts discussed in the two sources.FindingsThe academic and practitioners' debate highlights a trading zone among the two streams. patents' analysis from the EPO reveals four main common themes as a new business that benefits from AI in weather predictions, new smart and intelligent ways to monitor crops, new businesses that use clouds to control plant's humidity. The analysis of Scopus's sources demonstrates theoretical approaches related to the technology acceptance model (TAM) and practical strategies in terms of entrepreneurial skills to support the agricultural sector. However, barriers among the two streams of sources exist in innovation management and scale-up entrepreneurial initiatives.Research limitations/implicationsRegarding implications, the authors aim to connect academic and practitioners' views by understanding the new potential innovation applications and the connected new research avenues. Limitations might arise from the sources used to develop our analysis.Originality/valueThe paper is novel because it investigates the issues arising from the relationship between AE and new technologies by examining original validated patents released by practitioners and approved by the EPO, rather than reviewing blogs or the financial press. This leads to a holistic understanding of the impact of tangible practices among agricultural entrepreneurs. The results support the view that new trading zones and case studies are needed to highlight and show the positive impact of technologies in this field. The authors argue that practitioners require scholars to reduce the ambiguity between AE and its expected results, leading to investments to boost new agricultural business ideas.

scholarly journals Prevalence of asymptomatic malaria parasitaemia following mass testing and treatment in Pakro sub-district of Ghana

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Ignatius Cheng Ndong ◽  
Daniel Okyere ◽  
Juliana Yartey Enos ◽  
Benedicta A. Mensah ◽  
Alexander Nyarko ◽  
...  
Keyword(s):  
Scale Up ◽  
Intermittent Preventive Treatment ◽  
Indoor Residual Spraying ◽  
Asymptomatic Malaria ◽  
Malaria Parasitaemia ◽  
Axillary Temperature ◽  
Community Based ◽  
High Coverage ◽  
Asymptomatic Parasitaemia ◽  
The Impact

Abstract Background Global efforts to scale-up malaria control interventions are gaining steam. These include the use of Long-Lasting Insecticide Nets, Indoor Residual Spraying, Intermittent Preventive Treatment and Test, Treat and Track. Despite these, the drive for malaria elimination is far from being realistic in endemic communities in Africa. This is partly due to the fact that asymptomatic parasite carriage, not specifically targeted by most interventions, remains the bedrock that fuels transmission. This has led to mass testing, treatment and tracking (MTTT) as an alternative strategy to target asymptomatic individuals. We report the impact of MTTT on the prevalence of asymptomatic malaria parasitaemia over a one-year period in Ghana, hypothesizing that implementing MTTT could reduce the rate of asymptomatic parasitaemia. Methods A population of about 5000 individuals in seven communities in the Pakro sub-district of Ghana participated in this study. A register was developed for each community following a census. MTTT engaged trained community-based health volunteers who conducted house-to-house testing using RDTs every 4 months and treated positive cases with Artemisinin–based Combination Therapy. Between interventions, community-based management of malaria was implemented for symptomatic cases. Results MTTT Coverage was 98.8% in July 2017 and 79.3% in July 2018. Of those tested, asymptomatic infection with malaria parasites reduced from 36.3% (1795/4941) in July 2017 to 32.9% (1303/3966) in July 2018 (p = 0.001). Prevalence of asymptomatic parasitaemia among children under 15 years declined from 52.6% (1043/1984) in July 2017 to 47.5% (820/1728) in July 2018 (p = 0.002). Implementing MTTT significantly reduced asymptomatic parasitaemia by 24% from July 2017 to July 2018 after adjusting for age, ITN use and axillary temperature (OR = 0.76, CI = 0.67, 0.85 p ≤ 0.001). Conclusion This study has demonstrated that implementing MTTT is feasible and could reduce the prevalence of asymptomatic malaria parasitaemia in children under 15 years of age. Furthermore, the use of community-based health volunteers could ensure high coverage at lower cost of implementation. Trial registration NCT04167566, Date 14/11/2019. Retrospective registration.

Quantify the Weld Line and its Optimization Based on the Taguchi and the Moldflow Secondary Development

2013 ◽  
Vol 444-445 ◽  
pp. 1021-1025
Author(s):  
Zhi Shan ◽  
Shu Hao Qin ◽  
Liang Qiang Wei
Keyword(s):  
Experimental Data ◽  
Process Parameters ◽  
Process Design ◽  
Weld Line ◽  
Secondary Development ◽  
Orthogonal Experimental Design ◽  
Forming Process ◽  
The Impact ◽  
The Relationship ◽  
Important Basis

Designed the weld line quantization algorithm based on the moldflow secondary development of technology, obtained the numerical experimental data of weld line with this. Analyzed of the impact of the relationship between the process parameters and weld line, and optimized the process parameters by orthogonal experimental design. These provided an important basis for the forming process design.

scholarly journals The Impact of Environmental Factors on Malaria Prevalence in a Peri-Urban Community in Kwara State, Nigeria

2014 ◽  
Vol 3 (3) ◽  
pp. 173
Author(s):  
Olubunmi Ajike Mokuolu ◽  
Oluwayemisi D Adegboye ◽  
Olugbenga A Mokuolu
Keyword(s):  
Environmental Factors ◽  
Malaria Prevalence ◽  
Sampling Procedure ◽  
Multiple Regression Equation ◽  
Published Data ◽  
Community Based ◽  
The Impact ◽  
The Relationship ◽  
Selection Of ◽  
Structured Questionnaire

<p>There is a consensus on the relationship between Malaria Prevalence (MP) and Environmental Factors (EF); however, there is a dearth of published data providing this evidence in a quantifiable way. This community based study was undertaken to identify the magnitude of the relationship between MP and key environmental factors in Okelele, Ilorin East Local Government Area of Kwara State, Nigeria. A multi-staged sampling procedure was adopted for the selection of 501 children from 200 households. Children under the age of 14 years in the selected households were sampled to obtain baseline MP using malaria Rapid Diagnostic Test (mRDT) kit. Key household informant interviews and structured questionnaire were used. Relevant socio-demographic characteristics of the households, EF and non EF were determined. Acquired data was analyzed using statistical tools to determine the relationship between various independent variables and mRDT. Variables were also entered into a multiple regression equation for the generation of a mathematical model. Ethical consent was obtained from the parents before samples were taken.The study showed that EF contributed to MP in the study area.  Integrated waste management system, and regular environmental sanitation were recommended.</p>

scholarly journals Promotion of Producer Contribution to Solve Packaging Waste Issues - Viewpoints of Waste Bank Members in the Bandung Area, Indonesia

2021 ◽  
Author(s):  
Antonius Priyo Nugroho Sulami ◽  
Takehiko Murayama ◽  
Shigeo Nishikizawa
Keyword(s):  
Waste Management ◽  
Waste Reduction ◽  
Public Knowledge ◽  
Community Based ◽  
Product Packaging ◽  
Packaging Waste ◽  
Reduction Activity ◽  
Waste Bank ◽  
The Impact ◽  
The Relationship

Abstract As regulations have developed, the waste management sector in Indonesia has increasingly expected producer involvement in waste reduction activity through the enactment of new regulations. In addition, recent development of the waste management sector now involves community-based approaches such as Waste Banks. This study aims to determine the relationship between extended producer responsibility implementation and the waste bank concept. A questionnaire survey was designed and applied to Waste Bank members of two Waste Banks in Bandung municipality, Indonesia. Several factors were identified that can be considered by producers to promote their contribution in dealing with the packaging waste issue, such as producer consideration and contribution, knowledge level, collection, and awareness of the importance of packaging waste issue. The result also shows that involving feedback from Waste Banks can provide some insights to expand and develop producer contribution in reducing the impact of packaging waste. Producers can improve collection and recyclability of their product packaging while increasing public knowledge on their activity at the post-consumer stage.

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