scholarly journals Preparation of a Nonclinical Overview Based on Scientific Literature

2021 ◽  
Vol 11 (4) ◽  
pp. 263-272
Author(s):  
G. N. Engalycheva ◽  
R. D. Syubaev
Keyword(s):  
Literature Review ◽  
Medicinal Product ◽  
Scientific Literature ◽  
Preclinical Data ◽  
Eurasian Economic Union ◽  
Benefit Risk Assessment ◽  
Toxicological Data ◽  
Speed Up ◽  
Registration Dossier ◽  
Methodological Aspects

Current requirements for the registration dossier include submission of a preclinical (nonclinical) overview, including scientific literature data on preclinical studies and actual preclinical data on the medicinal product. For some groups of medicines, scientific literature data may be used instead of actual preclinical data, which may be redundant. One of the important functions of the scientific literature review is the analysis of updated preclinical information on the medicinal product, which reflects the product’s characteristics, supports conclusions on its efficacy or safety, and may affect the results of the benefit/risk assessment. The aim of the study was to determine the optimal format for presenting scientific literature data in a nonclinical overview that would reflect the methodological aspects of preclinical pharmacology and toxicology studies of medicines. The authors analysed the regulations of the Russian Federation and the Eurasian Economic Union containing requirements for the scientific literature review submitted instead of actual preclinical data as part of the registration dossier for a medicinal product. The authors also considered potential difficulties in preparing a nonclinical overview based on scientific literature. In order to systematise scientific literature data, it is recommended to provide pharmacodynamic, pharmacokinetic, and toxicological data using a format consistent with the common technical document. The proposed recommendations help to harmonise the process of preparation and design of a nonclinical overview which should contain data and facts enabling a reasoned assessment of the benefit/risk ratio. The standardised format of literature data presentation will help the developer prepare an adequate nonclinical overview and will speed up assessment of clinical trial or marketing authorisation applications.

scholarly journals Justification of Safety of Homeopathic Medicines in a Registration Dossier

2019 ◽  
Vol 7 (4) ◽  
pp. 200-215
Author(s):  
R. D. Subaev ◽  
G. N. Engalycheva ◽  
D. V. Goryachev
Keyword(s):  
Scientific Literature ◽  
The European Union ◽  
Objective Criterion ◽  
Additional Information ◽  
Registration Data ◽  
Eurasian Economic Union ◽  
Bibliographic Data ◽  
The Russian Federation ◽  
Simplified Procedure ◽  
Registration Dossier

Regulatory approaches to assessing the safety of homeopathic medicines in the Russian Federation and abroad are formed in accordance with regulatory acts, national and international rules and guidelines. Scientific literature is particularly important for justification of safety of homeopathic medicines. The purpose of this study was to determine the requirements and procedure for presenting justification of homeopathic medicines safety in the registration dossier in accordance with the documents of the Eurasian Economic Union and the European Union. According to the current Russian and foreign regulatory approaches the safety may be justified by scientific literature data on homeopathic use and by substantiation of the dosage in the case of medicines that have long experience of safe use and those that are authorized under a simplified procedure based on a dossier with a product instruction that does not establish indications for use. In both cases, there is no need to provide the results of preclinical or clinical studies of the drug. This approach reflects specific features of homeopathic medicines. An objective criterion of the safety of homeopathic medicines is the assessment of the dosage of active substances, taking into account the «first safe dilution» of homeopathic substances. A formal safety justification using registration data for similar drugs or additional information on the use of these pharmaceutical substances in homeopathy is also possible, but may be insufficient. The completeness and proper documentation of bibliographic data are the main criteria for an appropriate rationale for the safety of homeopathic products. 

On the use of leading safety indicators in maritime and their feasibility for Maritime Autonomous Surface Ships

2021 ◽  
pp. 1748006X2110276
Author(s):  
Krzysztof Wróbel ◽  
Mateusz Gil ◽  
Przemysław Krata ◽  
Karol Olszewski ◽  
Jakub Montewka
Keyword(s):  
Literature Review ◽  
Current Practice ◽  
Scientific Literature ◽  
Research Effort ◽  
Holistic Approach ◽  
Research Directions ◽  
Safety Critical ◽  
Intact Stability ◽  
Conference Papers ◽  
Operational Aspects

Although the safety of prospective Maritime Autonomous Surface Ships will largely depend on their ability to detect potential hazards and react to them, the contemporary scientific literature lacks the analysis of how to achieve this. This could be achieved through an application of leading safety indicators. The aim of the performed study was to identify the research directions of leading safety indicators in three safety-critical operational aspects of Maritime Autonomous Surface Ships: collision avoidance, intact stability, and communication. To achieve this, literature review is performed, taking into account scientific documents including journal and conference papers. The results indicate that the need for establishing operational leading safety indicators is recognized by numerous scholars, who sometimes make suggestions of what the set of indicators shall consist of. Some leading safety indicators for autonomous vessels are readily identifiable in the scientific literature and used in current practice. However, the research effort is lacking a holistic approach to the issue.

Systematic Literature Review of the Natural Environment of the Coromandel Peninsula, New Zealand, from a Conservation Perspective

Conservation ◽  
2021 ◽  
Vol 1 (4) ◽  
pp. 270-284
Author(s):  
Vladyslav Zakharovskyi ◽  
Károly Németh
Keyword(s):  
New Zealand ◽  
Literature Review ◽  
Scientific Literature ◽  
Terrestrial Environment ◽  
Scientific Databases ◽  
Cultural Aspects ◽  
The North ◽  
Current State ◽  
Geological Evolution ◽  
Silver Mineralization

This research presents a literature review of published scientific literature on the Coromandel Peninsula, a well-known region of the northern part of the North Island of New Zealand. It contains many biological, geological, and historical features and is well known for beautiful scenery, resulting from a volcanic rock-dominated terrestrial environment influenced by oceanic factors at the coast. All these factors have combined to make the Coromandel a popular tourism destination for New Zealanders and offshore visitors. In researching the current state of knowledge of the region, we searched three scientific databases to define the main ways of studying the region. The results demonstrated a high interest in biological and environmental factors, reflected in the type and scale of conservation measures applied to flora and fauna of the region. Additionally, specificity of geological evolution was a highly examined subject, in the context of hydrothermal alteration as related to gold and silver mineralization resulting in extensive exploration and mining. Meanwhile, indigenous cultural aspects of the land were not recognizable as expected within Western scientific literature, even though the region contains sites recognized as some of the earliest Māori habitations. Therefore, we suggest future studies to expand our understanding of scientific, cultural, and social aspects of the region as applied to the field of conservation in the region.

scholarly journals Analysis of the effectiveness of aspirin for the prevention of preeclampsia and alternative methods of prevention

2021 ◽  
Vol 20 (1) ◽  
pp. 70-75
Author(s):  
E. V. Kudryavceva ◽  
V. V. Kovalev ◽  
N. N. Bayazitova ◽  
N. M. Milyaeva ◽  
A. V. Kaumova
Keyword(s):  
Literature Review ◽  
Scientific Literature ◽  
Alternative Methods ◽  
Relative Reduction ◽  
Preventive Strategy ◽  
Hypertensive Disorder ◽  
Scientific Review ◽  
Continue Research ◽  
Potential Alternative ◽  
Hypertensive Disorder Of Pregnancy

Introduction. Preeclampsia is a hypertensive disorder of pregnancy that remains one of e leading causes of maternal and perinatal morbidity and mortality. The preventive strategy of prophylaxis with acetylsalicylic acid gives only a relative reduction in risk, and in a significant part of cases is ineffective. At the same time, the issue of preeclampsia prophylaxis is extremely relevant, since there are no effective methods for treating this condition, with the exception of the completion of gestation.Purpose of the study. Based on the scientific literature, to evaluate the effectiveness of aspirin in the prevention of preeclampsia and to determine the possible reasons for the lack of effectiveness of such prevention.Materials and methods. We conducted a search for scientific literature, as a result of which 39 sources were selected for the final scientific review (2010-2020). The PubMed, ResearchGate and Elibrary databases were used to search for scientific literature.Results and discussion. The article presents a literature review of the analysis of the effectiveness of aspirin for the prevention of preeclampsia over the past 5 years, describes the mechanism of action of aspirin, presents studies that confirm or refute the effectiveness of aspirin depending on the dosage and gestational age. Potential alternative agents for the prevention of preeclampsia in cases of aspirin ineffectiveness have been reviewed.Conclusion. Literature review data show that the effectiveness of aspirin for the prevention of preeclampsia depends on the chronobiological effect, compliance, gestational duration and dosage. It is necessary to continue research on the effectiveness of aspirin, and studies carried out on the Russian population will be of particular value for the Russian Federation.

scholarly journals Vulnerability and Primary Health Care: An Integrative Literature Review

2021 ◽  
Vol 12 ◽  
pp. 215013272110497
Author(s):  
Janise Braga Barros Ferreira ◽  
Luciane Loures dos Santos ◽  
Luciana Cisoto Ribeiro ◽  
Belkiss Rolim Rodrigues Fracon ◽  
Sabrina Wong
Keyword(s):  
Health Care ◽  
Primary Health Care ◽  
Literature Review ◽  
Scientific Literature ◽  
Inclusion Criteria ◽  
Primary Health ◽  
Theoretical Perspectives ◽  
Final Sample ◽  
Theoretical Foundations

The objective was to analyze the evidence available in the scientific literature on the concept of vulnerability, in theoretical perspectives and its use, in Primary Health Care. An integrative literature review was carried out with the inclusion criteria: articles in English, full text, peerreviewed, related to vulnerability and primary health care, with the explicit concept of vulnerability, and published until July 31, 2020. The electronic databases accessed were by crossing the descriptors “vulnerability,” “vulnerabilities,” “primary health care,” “primary healthcare,” and “primary care.” The final sample consisted of 19 articles. The thematic analysis produced 2 themes: “Theoretical foundations of the concept of vulnerability” and “The use of the concept of vulnerability in PHC.” In the second theme, 2 sub-themes emerged: Evaluation of health policies, programs, and services and Classification of individuals, groups, and families. There was a plurality of theoretical foundations for the concept of vulnerability and a smaller scope of its use in Primary Health Care. It is expected that the study will subsidize public policymakers and health teams in the design of services and actions aimed at vulnerable populations and in situations of vulnerability.

scholarly journals The Cauldron Has Cooled Down: A Systematic Literature Review on COVID-19, Ghost Games, and Home Advantage in Football from a Behavioral Science Perspective

2021 ◽  
Author(s):  
Michael Christian Leitner ◽  
Frank Daumann ◽  
Florian Follert ◽  
Fabio Richlan
Keyword(s):  
Literature Review ◽  
Systematic Literature Review ◽  
Scientific Community ◽  
Scientific Literature ◽  
Behavioral Science ◽  
Empirical Studies ◽  
Home Advantage ◽  
Empirical Perspective ◽  
Considerable Impact ◽  
Behavioral Perspective

The phenomenon of home advantage (or home bias) is well-analyzed in the scientific literature and is traditionally an interdisciplinary topic. Current theorizing views the fans as a crucial factor influencing the outcome of a football (a.k.a. soccer) game, as the crowd influences the behavior of the players and officials involved in the game through social pressure. So far, the phenomenon has been difficult to study because, although there have always been single matches where the spectators were excluded, this never happened globally to all teams within a league or even across leagues. From an empirical perspective, the situation with COVID-19 governmental measures, especially the ban of fans from stadiums all over the world, can be interpreted as a “natural experiment” and analyzed accordingly. Thus, several studies examined the influence of supporters by comparing matches before the COVID-19 restrictions with so-called ghost games during the pandemic. To synthesize the existing knowledge after over a year of ghost games and to offer the scientific community and other stakeholders an overview regarding the numerous studies, we provide a systematic literature review that summarizes the main findings of empirical studies and discusses the results accordingly. Our findings - based on 16 studies - indicate that ghost games have a considerable impact on the phenomenon of home advantage. No study found an increased home advantage in ghost games. Rather, our results show that 13 (from 16 included) analyzed studies conclude – based on their individually analyzed data – a more or less significant decrease of home advantage in ghost games. We conclude that our findings are highly relevant from a both socio-economic and behavioral perspective and highlight the indirect and direct influence of spectators and fans on football. Our results have – besides for the scientific community – a high importance for sports and team managers, media executives, fan representatives and other responsible.

scholarly journals Forecasting tomorrow’s tourist

2016 ◽  
Vol 8 (6) ◽  
pp. 643-653 ◽  
Author(s):  
Sérgio Moro ◽  
Paulo Rita
Keyword(s):  
Literature Review ◽  
Design Methodology ◽  
Scientific Literature ◽  
Recent Literature ◽  
Demand Forecasting ◽  
Tourism Demand ◽  
Content Type ◽  
Current Trends ◽  
Modeling Techniques ◽  
Excellent Source

Purpose This study aims to present a very recent literature review on tourism demand forecasting based on 50 relevant articles published between 2013 and June 2016. Design/methodology/approach For searching the literature, the 50 most relevant articles according to Google Scholar ranking were selected and collected. Then, each of the articles were scrutinized according to three main dimensions: the method or technique used for analyzing data; the location of the study; and the covered timeframe. Findings The most widely used modeling technique continues to be time series, confirming a trend identified prior to 2011. Nevertheless, artificial intelligence techniques, and most notably neural networks, are clearly becoming more used in recent years for tourism forecasting. This is a relevant subject for journals related to other social sciences, such as Economics, and also tourism data constitute an excellent source for developing novel modeling techniques. Originality/value The present literature review offers recent insights on tourism forecasting scientific literature, providing evidences on current trends and revealing interesting research gaps.

Theoretical and Empirical Comparative Analysis on Quantitative and Qualitative Marketing Researches

2015 ◽  
pp. 1712-1730
Author(s):  
Piotr Tarka ◽  
Mirosława Kaczmarek
Keyword(s):  
Qualitative Research ◽  
Comparative Analysis ◽  
Literature Review ◽  
Empirical Research ◽  
Marketing Research ◽  
Research Projects ◽  
Research Project ◽  
Quantitative And Qualitative Research ◽  
Similarities And Differences ◽  
Methodological Aspects

This chapter focuses on the similarities and differences between quantitative and qualitative marketing research projects and the possibilities of combining them in triangulation. The comparative analysis of both types of the research was conducted on the basis of literature review and the empirical research results, which were obtained from the evaluation of usability of Polish bank website. In the following sections, the authors discuss issues such as: 1) specificity of quantitative vs. qualitative marketing research, with regards to the implemented research projects; 2) methodological aspects of quantitative and qualitative research. They compare the selected research and sampling methods. Also, the problems which may occur with reference to quantitative and qualitative marketing research triangulation on different stages of the research project are discussed. Moreover, strengths and weaknesses of triangulation are analyzed. At the end, the example of quantitative and qualitative triangulation in the research project investigating the usability of websites is presented.

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