scholarly journals Regulatory requirements for Vaccine registration in United States

2018 ◽  
Vol 6 (2) ◽  
pp. 85-91 ◽  
Author(s):  
Shailaja Pashikanti ◽  
Sowmya A.N.V.L ◽  
Jyothi Sri Durga V

Vaccination is one among the foremost cost-efficient health interventions out available, saving a lot of individuals from illness, incapacity, and death annually. No alternative countermeasures are effective in reducing or eliminating the prevalence of infectious diseases reminiscent of measles, mumps, rubella, smallpox, and diphtheria. Vaccines are products of biological origin that exhibit some inherent variability. They are characterized by advanced manufacturing processes and are administered to a huge number of healthy youngsters, adolescents, and adults. Their quality cannot be assessed by testing the ultimate product alone. The vaccine industry is highly regulated. Vaccines development maybe an advanced and long method. Before a new vaccine is approved for release into the market, a rigorous restrictive procedure to assess quality, effectiveness, and safety should be undertaken. The Office of Vaccines Research and Review (OVRR) at the Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA) are responsible for the regulation of Vaccines. Current authority for the regulation of vaccines is in Section 351(a) of the Public Health Service Act (PHS).  Throughout the lifecycle of development, from preclinical studies to licensure, vaccines are subjected to rigorous testing and oversight. Manufacturers should adhere to good manufacturing practices and management procedures to make sure the quality of vaccines.

SAGE Open ◽  
2016 ◽  
Vol 6 (4) ◽  
pp. 215824401667177 ◽  
Author(s):  
Jennifer Edgar ◽  
Joe Murphy ◽  
Michael Keating

Cognitive interviewing is a common method used to evaluate survey questions. This study compares traditional cognitive interviewing methods with crowdsourcing, or “tapping into the collective intelligence of the public to complete a task.” Crowdsourcing may provide researchers with access to a diverse pool of potential participants in a very timely and cost-efficient way. Exploratory work found that crowdsourcing participants, with self-administered data collection, may be a viable alternative, or addition, to traditional pretesting methods. Using three crowdsourcing designs (TryMyUI, Amazon Mechanical Turk, and Facebook), we compared the participant characteristics, costs, and quantity and quality of data with traditional laboratory-based cognitive interviews. Results suggest that crowdsourcing and self-administered protocols may be a viable way to collect survey pretesting information, as participants were able to complete the tasks and provide useful information; however, complex tasks may require the skills of an interviewer to administer unscripted probes.


2010 ◽  
pp. 1193-1205
Author(s):  
M. Manuela Cruz-Cunha ◽  
António Tavares ◽  
Isabel Miranda

The healthcare sector has been continuously growing in importance in the past years throughout the entire world, and particularly in most Western countries and the U.S., where we witness an increase of expenditure in health per capita every year. This is related to many aspects of contemporary society, including an increase in life expectancy, the public demand for a better quality of life and better health services. This must be met with more cost-efficient approaches, and new technology-based solutions for providing health and other services. The chapter contextualizes the utilization of electronic marketplaces (e-marketplaces) for the social and healthcare sectors, how this field has been evolving in recent years, current challenges and trends, and their contribut to society. The authors also discuss a pilot project of an e-marketplace for healthcare and social services currently being developed in the Guimarães Municipality, including its goal, definition and implementation, as well as the commercially available enabling technology and tools.


2021 ◽  
Vol 2120 (1) ◽  
pp. 012006
Author(s):  
S Ashvinderjit ◽  
W J Kelvin Chew

Abstract The availability and cost of tools are among concerns to the public and industries as key operation device used either for commercial or maintenance purposes such precision grinders or polishing machines are usually expensive. Assorted grinding tools in the market differ in terms of cost, required user proficiency levels and have different tool designs that can lead to limitations of flatness of ground surface and significant vibrations with prolonged use. The aim of this study is to develop a design compact grinder that is able to perform precise grinding and polishing while being cost efficient. Both functionality and ergonomic aspects were taken into consideration with market standards derived from datasheets. An initial design of the grinding machine was made using SolidWorks CAD software. A prototype was subsequently constructed and tested by using typical metallurgical sample preparation process with test parameters of grade of grinding paper and usage of lubricant. Microscopic image of ground specimens showed improvement in the quality of grinding with emery paper grades from coarse to fine grits with lubricant during the grinding process. Moreover, the designed compact grinding machine showed better surface finish when compared to using a typical angle grinder on aluminium sample.


2020 ◽  
Vol 25 ◽  
pp. 05009
Author(s):  
Natalia Kurapina ◽  
Мaxim Ratanov ◽  
Olga Nikolskaya ◽  
Yelena Kikteva

In recent years, the viticulture industry, and the problems of producers of grape products have attracted more attention from the state and the public in terms of its contribution to GDP growth. Productivity and longevity of grape plantations directly depend on the quality of the planting material. Therefore, the relevance of research to obtain the highest yield of standard seedlings of valuable table grapes (Yubilei of Novocherkassk, Dubovsky pink, Bogatyanovsky, Vera) is undeniable. Two variants of biostimulators of growth have been studied: amino peptide agrochemical and a complex mean of chitosan and succinic acid in comparison with background fertigation. The highest yield of seedlings of the first grade level 71-76 % of the open ground nursery on light chestnut soils obtained by its cultivation with a three-time application of foliar fertilizing of amino peptide mean of biological origin Isabion at a dose of 2 l/ha with the addition seedlings output relative to the control 10-13% and the level of production profitability from 135 to 151 %.


Author(s):  
M. Manuela Cruz-Cunha ◽  
Ricardo Simões ◽  
António Tavares ◽  
Isabel Miranda

The healthcare sector has been continuously growing in importance in the past years throughout the entire world, and particularly in most Western countries and the U.S., where we witness an increase of expenditure in health per capita every year. This is related to many aspects of contemporary society, including an increase in life expectancy, the public demand for a better quality of life and better health services. This must be met with more cost-efficient approaches, and new technology-based solutions for providing health and other services. The chapter contextualizes the utilization of electronic marketplaces (e-marketplaces) for the social and healthcare sectors, how this field has been evolving in recent years, current challenges and trends, and their contribut to society. The authors also discuss a pilot project of an e-marketplace for healthcare and social services currently being developed in the Guimarães Municipality, including its goal, definition and implementation, as well as the commercially available enabling technology and tools.


Author(s):  
Marlene Kunst

Abstract. Comments sections under news articles have become popular spaces for audience members to oppose the mainstream media’s perspective on political issues by expressing alternative views. This kind of challenge to mainstream discourses is a necessary element of proper deliberation. However, due to heuristic information processing and the public concern about disinformation online, readers of comments sections may be inherently skeptical about user comments that counter the views of mainstream media. Consequently, commenters with alternative views may participate in discussions from a position of disadvantage because their contributions are scrutinized particularly critically. Nevertheless, this effect has hitherto not been empirically established. To address this gap, a multifactorial, between-subjects experimental study ( N = 166) was conducted that investigated how participants assess the credibility and argument quality of media-dissonant user comments relative to media-congruent user comments. The findings revealed that media-dissonant user comments are, indeed, disadvantaged in online discussions, as they are assessed as less credible and more poorly argued than media-congruent user comments. Moreover, the findings showed that the higher the participants’ level of media trust, the worse the assessment of media-dissonant user comments relative to media-congruent user comments. Normative implications and avenues for future research are discussed.


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