scholarly journals Antiepileptogenesis and disease modification: Clinical and Regulatory Issues

2021 ◽  
Author(s):  
Jacqueline A. French ◽  
Martina Bebin ◽  
Marc A. Dichter ◽  
Jerome Engel ◽  
Adam L. Hartman ◽  
...  
Keyword(s):  
Disease Modification ◽  
Regulatory Issues

Regulatory Issues in Pakistan Telecommunication

1998 ◽  
Vol 37 (4II) ◽  
pp. 873-882 ◽  
Author(s):  
Sarfaraz Khan Quershi
Keyword(s):  
National Economy ◽  
Cost Effective ◽  
Market Forces ◽  
Global Trends ◽  
Regulatory Issues ◽  
Competitive Price ◽  
Modern Services ◽  
A Company ◽  
Telecom Infrastructure

Growth in telecom infrastructure and provision of modern telecom services to consumers at a cost based tariff helps growth of national economy. Modern telecoms serve as the engine of growth of national economy. Following the global trends of liberalisation and deregulation in telecoms monopolies which have thus far been providing inefficient communication at a greedily high tariffs are falling apart. Mergers in telecoms are not for increasing the size of the monopoly but to provide more efficient and cost effective services to the consumers. In Pakistan the erstwhile T&T department played a needful role at its time. Conversion of the department into a corporation and then into a company were steps necessary for following the global trends. Need now is to continue this trend further, eliminate the monopolistic approach by allowing more players in the field thus permitting the market forces to decide the provision of better quality of modern services at competitive price.

scholarly journals The Role of Statins in Disease Modification and Cardiovascular Risk in Rheumatoid Arthritis

2018 ◽  
Vol 5 ◽  
Author(s):  
Stergios Soulaidopoulos ◽  
Elena Nikiphorou ◽  
Theodoros Dimitroulas ◽  
George D. Kitas
Keyword(s):  
Rheumatoid Arthritis ◽  
Cardiovascular Risk ◽  
Disease Modification

Microalgae as source of functional ingredients in new-generation foods: challenges, technological effects, biological activity, and regulatory issues

2021 ◽  
pp. 1-22 ◽  
Author(s):  
Viviane Priscila Barros de Medeiros ◽  
Whyara Karoline Almeida da Costa ◽  
Ruthchelly Tavares da Silva ◽  
Tatiana Colombo Pimentel ◽  
Marciane Magnani
Keyword(s):  
Biological Activity ◽  
Functional Ingredients ◽  
Regulatory Issues ◽  
New Generation

A Social Enterprise Company in EU Organisational Law?

2021 ◽  
pp. 1-35
Author(s):  
J S LIPTRAP
Keyword(s):  
European Integration ◽  
European Commission ◽  
Social Enterprise ◽  
Social Economy ◽  
Member States ◽  
Regulatory Issues ◽  
Cross Border ◽  
The Social ◽  
Proposal A

Abstract This article explores the European Parliament's July 2018 non-legislative resolution proposing to the European Commission a directive for facilitating social enterprise companies’ cross-border activities. The proposal is first situated within the context of the social economy and how the sector has grown in importance to European integration. The proposal and the European Commission's response are then examined. Although the European Commission was not convinced that Member States would be amenable to the proposal, a consensus may already exist that is sufficient to garner their support. Even if this prediction is wrong, however, it is argued that there are reasons to surmise that the proposal will likely be reassessed and ultimately successful at some future point. Finally, the proposal is viewed with a reflexive harmonisation lens. Through the analysis, regulatory issues are identified, and a solution is then suggested.

scholarly journals Commercial Bone Grafts Claimed as an Alternative to Autografts: Current Trends for Clinical Applications in Orthopaedics

Materials ◽  
2021 ◽  
Vol 14 (12) ◽  
pp. 3290
Author(s):  
Marco Govoni ◽  
Leonardo Vivarelli ◽  
Alessandro Mazzotta ◽  
Cesare Stagni ◽  
Alessandra Maso ◽  
...  
Keyword(s):  
Web Of Science ◽  
Bone Grafts ◽  
Clinical Applications ◽  
Bibliographic Databases ◽  
Market Demand ◽  
Regulatory Issues ◽  
Negative Results ◽  
Current Trends ◽  
Analyse Data ◽  
Cellular Bone

In the last twenty years, due to an increasing medical and market demand for orthopaedic implants, several grafting options have been developed. However, when alternative bone augmentation materials mimicking autografts are searched on the market, commercially available products may be grouped into three main categories: cellular bone matrices, growth factor enhanced bone grafts, and peptide enhanced xeno-hybrid bone grafts. Firstly, to obtain data for this review, the search engines Google and Bing were employed to acquire information from reports or website portfolios of important competitors in the global bone graft market. Secondly, bibliographic databases such as Medline/PubMed, Web of Science, and Scopus were also employed to analyse data from preclinical/clinical studies performed to evaluate the safety and efficacy of each product released on the market. Here, we discuss several products in terms of osteogenic/osteoinductive/osteoconductive properties, safety, efficacy, and side effects, as well as regulatory issues and costs. Although both positive and negative results were reported in clinical applications for each class of products, to date, peptide enhanced xeno-hybrid bone grafts may represent the best choice in terms of risk/benefit ratio. Nevertheless, more prospective and controlled studies are needed before approval for routine clinical use.

Measuring Disease Modification in Alzheimer's Disease

CNS Spectrums ◽  
2007 ◽  
Vol 12 (S1) ◽  
pp. 11-14
Author(s):  
Jeffrey L. Cummings
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Immunoglobulin A ◽  
Disease Process ◽  
Underlying Disease ◽  
Therapeutic Interventions ◽  
Disease Modification ◽  
Amyloid Disease ◽  
Therapeutic Modalities ◽  
Disease Modifying

AbstractWe appear to be on the brink of a new epoch of treatment for Alzheimer's disease. Compelling evidence suggests that Aβ42 secretion is the triggering event in the pathogenesis of Alzheimer's disease, and that tau aggregation may be an important secondary event linked to neurodegeneration. Prophylactic administration of anti-amyloid agents designed to prevent Aβ accumulation in persons with subclinical disease is likely to be more effective than therapeutic interventions in established Alzheimer's disease. Drug development programs in Alzheimer's disease focus primarily on agents with anti-amyloid disease-modifying properties, and many different pharmacologic approaches to reducing amyloid pathology and tauopathy are being studied. Classes of therapeutic modalities currently in advanced-stage clinical trial testing include forms of immunotherapy (active β -amyloid immunoconjugate and human intravenous immunoglobulin), a γ-secretase inhibitor, the selective Aβ42-lowering agent R-flurbiprofen, and the anti-aggregation agent tramiprosate. Non-traditional dementia therapies such as the HMG-CoA reductase inhibitors (statins), valproate, and lithium are now being assessed for clinical benefit as anti-amyloid disease-modifying treatments. Positive findings of efficacy and safety from clinical studies are necessary but not sufficient to demonstrate that a drug has disease-modifying properties. Definitive proof of disease-modification requires evidence from validated animal models of Alzheimer's disease; rigorously controlled clinical trials showing a significantly improved, stabilized, or slowed rate of decline in cognitive and global function compared to placebo; and prospectively obtained evidence from surrogate biomarkers that the treatment resulted in measurable biological changes associated with the underlying disease process.

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