scholarly journals Current hurdles to the translation of nanomedicines from bench to the clinic

2021 ◽  
Author(s):  
Snežana Đorđević ◽  
María Medel Gonzalez ◽  
Inmaculada Conejos-Sánchez ◽  
Barbara Carreira ◽  
Sabina Pozzi ◽  
...  
Keyword(s):  
Drug Product ◽  
Early Stage ◽  
Regulatory Agencies ◽  
Important Process ◽  
Close Collaboration ◽  
Critical Quality Attributes ◽  
Research Areas ◽  
Physical Chemical ◽  
Clinical Models ◽  
Further Development

AbstractThe field of nanomedicine has significantly influenced research areas such as drug delivery, diagnostics, theranostics, and regenerative medicine; however, the further development of this field will face significant challenges at the regulatory level if related guidance remains unclear and unconsolidated. This review describes those features and pathways crucial to the clinical translation of nanomedicine and highlights considerations for early-stage product development. These include identifying those critical quality attributes of the drug product essential for activity and safety, appropriate analytical methods (physical, chemical, biological) for characterization, important process parameters, and adequate pre-clinical models. Additional concerns include the evaluation of batch-to-batch consistency and considerations regarding scaling up that will ensure a successful reproducible manufacturing process. Furthermore, we advise close collaboration with regulatory agencies from the early stages of development to assure an aligned position to accelerate the development of future nanomedicines. Graphical abstract

Development of peripheral periderm from cork strips in Ceratoniasiliqua

1976 ◽  
Vol 6 (3) ◽  
pp. 425-428 ◽  
Author(s):  
Ehud Arbel ◽  
Tova Arzee
Keyword(s):  
Early Stage ◽  
Longitudinal Direction ◽  
Wing Development ◽  
Lateral Extension ◽  
Subsequent Formation ◽  
Further Development

The formation of cork in vertical strips on young branches of Ceratoniasiliqua L. is described. The cork strips represent an early stage in the development of peripheral periderm. Initiation of the cork ridges began with the differentiation of lenticels in vertical rows and further development occurred through the subsequent formation of periderm, primarily in the longitudinal direction. A circumfluent covering of periderm was formed eventually by lateral extension of phellogen leading to the gradual coalescence of the cork strips. Similarities with patterns of cork wing development are discussed.

scholarly journals System development for its disclosure of Portuguese digital type design

2016 ◽  
Author(s):  
Vítor Quelhas ◽  
Vasco Branco ◽  
Rui Mendonça
Keyword(s):  
Early Stage ◽  
System Development ◽  
Complete Agreement ◽  
Collaborative System ◽  
Test And Evaluation ◽  
Usability Tests ◽  
Type Design ◽  
Third Stage ◽  
Further Development

This study aims to cover the current development of a platform for the disclosure of the Portuguese type design community, since the beginning of the desktop revolution, until today. 
To deepen our understanding, interviews were made to a selected and representative group of type designers from our sample based on several criteria. The interview tested six dimensions: people, processes, products, uses, identity and platform. The results analyzed in the last dimension, through content analysis and quantitative data, lead to the development of an online digital collaborative system – one of our specific objectives. 
Our hypothesis – that the development of a online digital collaborative system would allow further development of knowledge between products, users and authors, as well as, processes and uses – was also corroborated by the interviewers. 
Reviews have been made to reference international online projects to identify their purposes, areas of activity, objectives, mechanisms of interaction, usability and accessibility. This previous research brought together a set of notes that would become essential in the definition and development of our concept. 

The classification of typefaces is a subject of study by researchers and designers, but it is certainly not a topic for complete agreement. Organizing and balancing the content for the database was our first challenge since we were expecting users with good knowledge on the field, but also beginners. Several diagrams were put into test during the early stage of information architecture to better define categories, filters, and sorting methods, as well as users role in the system. The items and categories chosen were redefined in a second stage, and in the third stage hi-fidelity wireframes were produced, to concentrate on design aspects and decisions, and put the system into test and evaluation. 

The current results on the platform development, with the improvements made through several user tests, evaluations and refinements undertaken in all phases of the project have been crucial. We are expecting to run some pilot tests, as well as usability tests prior to the full implementation to further improve the system and meet the expectations.DOI: http://dx.doi.org/10.4995/IFDP.2016.3351

scholarly journals Rotulagem de medicamentos industrializados: uma análise das diretrizes legais brasileiras e contribuições para a qualidade de produtos

2020 ◽  
Vol 20 (81) ◽  
Author(s):  
Márcia Lombardo
Keyword(s):  
Drug Product ◽  
Regulatory Agencies ◽  
Quality And Safety ◽  
Sources Of Information ◽  
Normative Documents ◽  
Drug Products ◽  
Legal Provisions ◽  
Product Surveillance ◽  
Study Results ◽  
Regulatory Knowledge

RESUMOObjetivos: a rotulagem é um aspecto de qualidade fundamental no uso de medicamentos, seja pelo profissional de saúde, seja pelo paciente. Este trabalho propôs uma análise crítica do tema com base na legislação em vigor, bem como a triagem de documentos normativos úteis no processo de elaboração ou de avaliação da conformidade da rotulagem de medicamentos. Métodos: foi realizada uma pesquisa documental empregando-se como fonte de informações os sítios eletrônicos oficiais do Ministério da Saúde e da Agência Nacional de Vigilância Sanitária. Os documentos contendo itens pertinentes a rotulagem de medicamentos e classificados como vigentes ou vigentes com alteração foram selecionados para a realização do estudo. Resultados: os quesitos mais relevantes das disposições gerais e das disposições específicas da norma vigente para rotulagem de medicamentos foram sistematizados, verificando-se suas contribuições na qualidade e segurança de produtos. Embora a padronização da rotulagem de medicamentos seja necessária, a ocorrência de elevados graus de semelhança entre rótulos, embalagens ou mesmo nomenclaturas é discutida no âmbito da prática clínica e esta questão merece atenção especial. A busca de material complementar à legislação vigente resultou no levantamento de um total de 20 documentos, incluindo normas, guias, bancos de consulta e planilhas, que podem auxiliar no cumprimento dos requisitos de rotulagem de medicamentos. Conclusão: rótulos de medicamentos são recursos técnicos que contribuem na eficácia e na segurança do tratamento. Os esforços das Agências Reguladoras têm permitido a consolidação de diretrizes legais para que informações e formatos adequados de rotulagem sejam aplicados nas embalagens de medicamentos industrializados. A elaboração ou a análise da rotulagem de medicamentos requer amplo conhecimento regulatório, o qual é dinâmico e, portanto, um grande desafio.Palavras-chave: Rotulagem de Medicamentos. Legislação de Medicamentos. Vigilância de Produtos Comercializados. Segurança do Paciente. ABSTRACTObjectives: the labeling of drug products is an aspect of quality that is fundamental to the use of medicines, whether by the health professional or by the patient. This work proposed a critical analysis of the current legislation on the labeling of drug products, as well as the screening of normative documents useful for the process of preparing or assessing the conformity of labels. Methods: a documentary research was carried out using the official websites of the Ministry of Health and the National Health Surveillance Agency (Brazil) as sources of information. The documents containing relevant items on labeling of drug products and classified as current or current with changes were selected for the study. Results: the most important requirements of the general and specific provisions from the current legislation have been systematized, and their contributions to the quality and safety of products have been verified. Although the standardization of the labeling is necessary, the occurrence of high degrees of similarity between labels, packaging or even nomenclatures is discussed in the context of clinical practice and this issue deserves special attention. The search for material complementary to the current legislation resulted in the collection of a total of 20 documents, including normative documents, guides, databases and spreadsheets, which might help in complying with the requirements for the labeling of drug products. Conclusion: the labeling of drug products are technical resources that contribute to the effectiveness and safety of treatment. The efforts of the Regulatory Agencies have allowed the consolidation of legal provisions for the dissemination of appropriate information and labeling formats in the packaging of drug products. The drafting or analysis of the labels requires extensive regulatory knowledge, which is dynamic and, therefore, a great challenge.Keywords: Drug Labeling. Legislation, Drug. Product Surveillance, Postmarketing. Patient Safety.

Abstract P311: Cardiac Sympathetic Afferents Does Not Initiate but Contributes to the Further Development of Hypertension in Spontaneous Hypertensive Rats

Hypertension ◽  
2016 ◽  
Vol 68 (suppl_1) ◽  
Author(s):  
Hanjun Wang ◽  
Irving H. Zucker
Keyword(s):  
Early Stage ◽  
Radio Telemetry ◽  
Critical Role ◽  
Sensory Nerve ◽  
Shr Rats ◽  
Hypertensive Rats ◽  
Post Intervention ◽  
Novel Therapy ◽  
Cardiac Afferents ◽  
Further Development

Sympatho-excitation plays a critical role in the pathogenesis of hypertension. However, it is unclear what factors initiate and maintain sympatho-excitation in hypertension. Our past studies have confirmed a critical role of cardiac sensory nerve endings that mediate a sympatho-excitatory reflex called the “cardiac sympathetic afferent reflex” (CSAR) in the setting of heart failure. However, whether/when the CSAR is activated and contributes to the development of hypertension remains unclear. To address this issue, we chronically abolished the CSAR by epidural application of a selective afferent neurotoxin, resiniferatoxin (RTX) at the level of the T1-T4 dorsal root ganglia (DRGs) by destroying TRPV1-expressing neuronal soma in 8-week and 16-w old spontaneous hypertensive rats (SHR). Conscious blood pressure was monitored before (baseline) and during 2 months post RTX using radio telemetry. As shown in Figure 1A, in early-hypertensive (8-w old) SHR rats, there was no difference in mean arterial pressure (MAP) between vehicle and RTX groups until 3 weeks post intervention. At that time, MAP in vehicle-treated SHR rats continued to increase whereas this increase was largely abolished in the RTX-treated group. In the established (16-w old) SHR rats (Figure 1B), treatment with RTX immediately reduced MAP by ~15 mmHg, which was maintained for the 2-month recording period. These data strongly suggest that although CSAR does not initiate hypertension at the early stage in SHR, it contributes to the further development of hypertension in the mid/late stages. These data support a potential novel therapy possibly involving cardiac afferents.

Potential Area of Research in MANET

2012 ◽  
pp. 391-407 ◽  
Author(s):  
Sudha Singh ◽  
D. K. Singh ◽  
Mr. Sudipta Mondal
Keyword(s):  
Ad Hoc Networks ◽  
Mobile Ad Hoc Networks ◽  
Vehicular Ad Hoc Networks ◽  
Ad Hoc ◽  
Early Stage ◽  
Battery Lifetime ◽  
Research Areas ◽  
Bounded Space ◽  
Mobile Ad Hoc ◽  
Hoc Networks

The growth of laptop and 802.11/Wi-Fi wireless networking have made Mobile Ad hoc NETworks (MANETs) a popular research topic since the mid to late 1990s. Many academic papers evaluate protocols and abilities assuming varying degrees of mobility within a bounded space, usually with all nodes within a few hops of each other and usually with nodes sending data at a constant rate. Different protocols are then evaluated based on the packet drop rate, the overhead introduced by the routing protocols, and other measures. Research in MANET is like playing in a vast playground with only few known rules and large number of unknown rules applied to its different areas. Some areas are still unknown and some areas are at its early stage. Some of the research challenges that MANET present are dynamic topologies, battery lifetime, disconnected operations, security, et cetera. In general there are three types of MANET: vehicular ad hoc networks, intelligent vehicular ad hoc network, and Internet based mobile ad hoc networks. Each of these three types has its own research areas.

SON in Location-Based Services

2016 ◽  
pp. 115-129
Author(s):  
Ramprasad Subramanian ◽  
Farhana Afroz ◽  
Kumbesan Sandrasegaran ◽  
Xiaoying Kong
Keyword(s):  
Cellular Networks ◽  
Ad Hoc ◽  
Location Based Services ◽  
Wireless Sensor ◽  
Clear Understanding ◽  
Position Accuracy ◽  
Research Areas ◽  
Applied Technology ◽  
Hoc Networks ◽  
Further Development

This chapter forays into the literature of emerging field of Self-Organization Network (SON) and its application in the area of location-based services. SON is a widely applied technology in the ad hoc networks, wireless sensor networks and automatic computer networks. This chapter deal exclusively about the projects, standards and literature of SON in the context of the cellular networks and how it can aid to achieve higher position accuracy information of the subscriber. Additionally, in this chapter a clear understanding of SON taxonomy and the guidelines for the design of SON has been presented and a comparison of SON with the existing solutions about its strength and weakness has been made in this chapter. The key research areas for further development is also highlighted in this chapter. This literature will provide comprehensive guidance for anyone interested to delve into the research of SON in cellular wireless communication and location based services.

Capturing Process Knowledge for Multi-Channel Information Systems

2012 ◽  
Vol 3 (1) ◽  
pp. 78-98 ◽  
Author(s):  
Shang Gao ◽  
John Krogstie
Keyword(s):  
Early Stage ◽  
Process Models ◽  
System Support ◽  
Knowledge Capture ◽  
Process Knowledge ◽  
Starting Point ◽  
Channel Information ◽  
Further Development ◽  
Goal Models

In this paper, a case study is used to evaluate the business process characterizing modeling (BPCM) language. The BPCM-framework is meant to guide both business stakeholders and model developers during model-based development. The focus of the approach is the use of BPCM as a starting point for capturing process knowledge when planning and developing information system support. Based on information within the BPCM models, goal models and process models can be developed and used for further development of the BPCM model. The approach in this paper is evaluated using a case study related to the arrangement of a conference series. Through the case study, the authors have confirmed the potential usability and usefulness of BPCM for early stage knowledge capture, getting input for further improvement of the approach.

scholarly journals Early Autism Screening: A Comprehensive Review

2019 ◽  
Vol 16 (18) ◽  
pp. 3502 ◽  
Author(s):  
Fadi Thabtah ◽  
David Peebles
Keyword(s):  
Autistic Spectrum Disorder ◽  
Early Stage ◽  
Screening Tools ◽  
Screening Methods ◽  
Statistical Manual ◽  
Diagnostic And Statistical Manual ◽  
Speed Up ◽  
Sensitivity Specificity ◽  
Further Development ◽  
Lengthy Process

Autistic spectrum disorder (ASD) refers to a neurodevelopmental condition associated with verbal and nonverbal communication, social interactions, and behavioural complications that is becoming increasingly common in many parts of the globe. Identifying individuals on the spectrum has remained a lengthy process for the past few decades due to the fact that some individuals diagnosed with ASD exhibit exceptional skills in areas such as mathematics, arts, and music among others. To improve the accuracy and reliability of autism diagnoses, many scholars have developed pre-diagnosis screening methods to help identify autistic behaviours at an early stage, speed up the clinical diagnosis referral process, and improve the understanding of ASD for the different stakeholders involved, such as parents, caregivers, teachers, and family members. However, the functionality and reliability of those screening tools vary according to different research studies and some have remained questionable. This study evaluates and critically analyses 37 different ASD screening tools in order to identify possible areas that need to be addressed through further development and innovation. More importantly, different criteria associated with existing screening tools, such as accessibility, the fulfilment of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) specifications, comprehensibility among the target audience, performance (specifically sensitivity, specificity, and accuracy), web and mobile availability, and popularity have been investigated.

An Approach for Representing and Evaluating User Tactics in Early Stage Product Development

2020 ◽  
Author(s):  
Trent Owens ◽  
Christopher A. Mattson ◽  
Carl D. Sorensen ◽  
Tyler Stapleton ◽  
Michael L. Anderson
Keyword(s):  
Product Development ◽  
Early Stage ◽  
Prior Experience ◽  
Design Stage ◽  
Design Evaluation ◽  
Development Effort ◽  
Technological Performance ◽  
Research Areas ◽  
Simultaneous Evaluation ◽  
Effective Design

Abstract Frequent and effective design evaluation is foundational to the success of any product development effort. Products that will be used, installed, or otherwise handled by humans would benefit from both an evaluation of the product itself (the physical embodiment of the technology, termed technology), and the steps a user should take to use that technology (termed tactics). Current methods for the evaluation of tactics are scattered across multiple research areas, and are often inaccessible to engineers who have no prior experience with them. Furthermore, the existing tactics evaluation methods often focus mostly on the use of a product and do not simultaneously consider technological performance. In this paper we present a method for the simultaneous evaluation of tactics and technology during the conceptual design stage. To achieve this, we propose three contributions; an approach for representing tactics concepts, a set of criteria for tactics evaluations, and a means for presenting the results of the technology/tactics evaluation to facilitate team ideation.

scholarly journals A Novel Text-Mining Approach for Retrieving Pharmacogenomics Associations From the Literature

2020 ◽  
Vol 11 ◽  
Author(s):  
Maria-Theodora Pandi ◽  
Peter J. van der Spek ◽  
Maria Koromina ◽  
George P. Patrinos
Keyword(s):  
Text Mining ◽  
Generalized Linear Models ◽  
Linear Models ◽  
Biomedical Literature ◽  
Linear Kernel ◽  
R Programming Language ◽  
Research Areas ◽  
Text Classifiers ◽  
R Programming ◽  
Further Development

Text mining in biomedical literature is an emerging field which has already been shown to have a variety of implementations in many research areas, including genetics, personalized medicine, and pharmacogenomics. In this study, we describe a novel text-mining approach for the extraction of pharmacogenomics associations. The code that was used toward this end was implemented using R programming language, either through custom scripts, where needed, or through utilizing functions from existing libraries. Articles (abstracts or full texts) that correspond to a specified query were extracted from PubMed, while concept annotations were derived by PubTator Central. Terms that denote a Mutation or a Gene as well as Chemical compound terms corresponding to drug compounds were normalized and the sentences containing the aforementioned terms were filtered and preprocessed to create appropriate training sets. Finally, after training and adequate hyperparameter tuning, four text classifiers were created and evaluated (FastText, Linear kernel SVMs, XGBoost, Lasso, and Elastic-Net Regularized Generalized Linear Models) with regard to their performance in identifying pharmacogenomics associations. Although further improvements are essential toward proper implementation of this text-mining approach in the clinical practice, our study stands as a comprehensive, simplified, and up-to-date approach for the identification and assessment of research articles enriched in clinically relevant pharmacogenomics relationships. Furthermore, this work highlights a series of challenges concerning the effective application of text mining in biomedical literature, whose resolution could substantially contribute to the further development of this field.

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