Introduction

2021 ◽  
pp. 1-26
Keyword(s):  
Nineteenth Century ◽  
Regulatory Agency ◽  
Marketing Authorisation ◽  
Evaluation Agency ◽  
Efficacy And Safety ◽  
Safety And Efficacy ◽  
Central European ◽  
Scientific Assessment ◽  
European Regulatory ◽  
The Uk

This chapter begins with the early regulation of medicines, which was concerned with quality rather than any scientific assessment of efficacy and safety. It describes the latter half of the nineteenth century wherein the need for objective scientific assessment of the safety and efficacy of new medicines and the concept of risk–benefit of medicines was born. It also talks about the configuration of the Licensing Authority in the UK and the European Medicines Evaluation Agency (EMEA) as a key provision of both the Medicines Act 1968 and the European medicines legislation. The chapter analyses Directive 2001/83/EC, which governs all the requirements for the contents of the application dossier and grant of marketing authorisation of medicinal products. It recounts the development of statutory controls in the UK that was consistent with the evolution of the overarching European medicines legislation and the formation of the central European regulatory agency.

The effect of RNA and non-RNA vaccines in variants of Covid-19: A narrative review

2021 ◽  
Vol 15 (7) ◽  
pp. 2112-2122
Author(s):  
Maryam Rahmannia ◽  
Shahryar Rajai Firouz Abadi ◽  
Ahad Hasan Syed Hasani ◽  
Fatemehzahra Khanali ◽  
Fatemeh Vosoughian ◽  
...  
Keyword(s):  
South African ◽  
The Other ◽  
Structural Proteins ◽  
Efficacy And Safety ◽  
Host Cell Membrane ◽  
Safety And Efficacy ◽  
Angiotensin Converting Enzyme 2 ◽  
The World ◽  
The Uk ◽  
New Mutations

Coronaviruses are detected in humans and mammals; these are big-size and single-stranded RNA viruses with nucleocapsid. SARS-CoV-2 has included four structural proteins (S, E, M, and N); between these proteins, S protein makes attaching ability in the virus. This ability causes the virus to bind to angiotensin-converting enzyme 2(ACE2) and host cell membrane in targeted tissues. Currently, several mutations of SARS-CoV-2 were identified. On the other hand, these new mutations cause SARS-CoV-2 to have different variants with various severity, such as the South African variant (B.1.351) and the UK variant (B.1.1.7). Throughout the COVID-19 pandemic, diverse therapeutics routes and prevention assays have been applied, following that several drugs and therapy assays have been investigated. One of the most important routes in this pandemic is the vaccine. Currently, at least in all of the world, almost 13 vaccines have been accepted with different mechanisms against COVID-19. This review explored current mRNA and non-mRNA vaccines against SARS-CoV-2 and their immunogenicity, safety, and Efficacy. We substantially focused on emerging mutations, the glycoprotein of the spike, and variants of concern (VOCs). Due to recently published articles of selected data, there were no specific outcomes to distinguished and compared between complete Efficacy and safety of approved vaccines against COVID-19. However, it must be noticed that widespread vaccination against SARS-CoV-2 and its different variants is necessary. This review is a novel study in the duration of the pandemic of COVID-19, and it needs additional particular studies. Hence we desire other scientists and related researchers to continue assessing this topic. Keywords: SARS-CoV-2, mRNA vaccines, non-mRNA vaccines, Efficacy of vaccine, COVID-19, Severe acute respiratory syndrome coronavirus 2, Mutation, Variant of coronavirus, public health

Efficacy and safety data for the Ab interno XEN45 gel stent implant at 3 Years: A retrospective analysis

2021 ◽  
pp. 112067212110143
Author(s):  
Itay E Gabbay ◽  
Mordechai Goldberg ◽  
Felicity Allen ◽  
Zhiheng Lin ◽  
Christine Morley ◽  
...  
Keyword(s):  
Intraocular Pressure ◽  
Failure Rate ◽  
Open Angle Glaucoma ◽  
Safety Data ◽  
Angle Closure ◽  
Efficacy And Safety ◽  
Antihypertensive Medications ◽  
Uk National Health Service ◽  
The Uk ◽  
Comparative Audit

Purpose: To report efficacy and safety measures of the XEN45 gel stent at 36 months in the UK National Health Service setting. Methods: Retrospective non-comparative audit of the records of patients who underwent XEN45 implantation between June 2015 and May 2017 was performed. Main outcome measures were intraocular pressure and number of antihypertensive medications used. Failure was defined as need for further surgery or stent removal. Success was defined as a 20% decrease in intraocular pressure without the need for additional glaucoma medications or a reduction in antihypertensive medications without an increase in baseline intraocular pressure. Needling rates and preoperative factors effect were assessed. Results: The cohort included 205 patients (205 eyes) with primary open angle glaucoma (84.4%), angle closure glaucoma (7.8%), or refractory glaucoma (7.8%), 62.9% had a stand-alone procedure and 37.1%, a combined phaco-XEN45 procedure. Mean intraocular pressure was 22.6 ± 7.0 mmHg at baseline compared to 14.7 ± 3.8 mmHg at 24 months and 14.0 ± 2.9 mmHg at 36 months ( p < 0.001 for both). Mean number of medications used was 2.6 ± 1.1 at baseline compared to 0.5 ± 0.9 and 0.6 ± 1.0, at 24- and 36-months, respectively ( p < 0.001 for both). The failure rate at 36 months was 25%. Needling was required in 36.6%. Evaluation of background factors yielded an increased failure rate in non-Caucasians compared to Caucasians (74% vs 21%, p < 0.001). Conclusion: XEN45 implantation is effective and safe at 36 months’ follow-up. Patients should be advised regarding the risk of failure and possible need for bleb revisions. Careful patient selection may be required.

scholarly journals Renal Vein Thrombosis and Pulmonary Embolism Secondary to Vaccine-induced Thrombotic Thrombocytopenia (VITT)

2021 ◽  
Author(s):  
Nikita Cliff-Patel ◽  
Lindsay Moncrieff ◽  
Veqas Ziauddin
Keyword(s):  
Pulmonary Embolism ◽  
General Hospital ◽  
Regulatory Agency ◽  
Renal Vein ◽  
District General Hospital ◽  
Renal Vein Thrombosis ◽  
The Other ◽  
Pulmonary Emboli ◽  
Vein Thrombosis ◽  
The Uk

The Medicines and Healthcare products Regulatory Agency (MHRA) of the UK has approved the use of three vaccines to combat COVID-19 (SARS-CoV-2). There have been rare reports of thrombosis after vaccination with the AstraZeneca vaccine. We present three cases of vaccine-induced thrombotic thrombocytopenia (VITT) in one UK district general hospital following administration of this vaccine. Two of the patients had asymptomatic pulmonary emboli, while the other is the first known case of both renal vein thrombosis and pulmonary embolism.

Eastward Ho! Aspects of Eastern European Writing Translated into Irish

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Alan Titley ◽  
Keyword(s):  
Nineteenth Century ◽  
Middle Ages ◽  
Literary Texts ◽  
General Tendency ◽  
Eastern European ◽  
Irish Language ◽  
Central European ◽  
Literary Expression ◽  
Reading Material ◽  
Eastern European Countries

The article focuses on translations into Irish of literary texts by writers from several central and eastern European countries. The author adopts a historical approach by first drawing attention to the Irish language as a means of literary expression and a vehicle for the translation of classical texts in the Middle Ages. Irish came under sustained attack because of English rule from the seventeenth century onwards and was only spoken by the poor and the marginalized in the middle of the nineteenth century. However, towards the end of the nineteenth century the language experienced a revival. The latter process was intensified following the establishment of the Irish Free State in 1922. In 1926, a project for literacy and provision of reading material in the Irish language was implemented, and a government publishing company known as An Gúm started producing books for the new Irish-reading public. Since the start of the project, the general tendency has been for books by western European writers to be translated into Irish. However, a significant number of texts by eastern and central European authors, ranging from classics by Tolstoy and Chekhov to novels and short stories by contemporary Russian and Slovenian authors, have also been published over the years.

The opioid crisis: evaluating the safety and efficacy of opioid analgesia in the management of acute post-operative dental pain

Dental Update ◽  
2021 ◽  
Vol 48 (10) ◽  
pp. 859-864
Author(s):  
Daniel Merrick ◽  
Michael O'Sullivan ◽  
Mary Clarke
Keyword(s):  
Management Strategies ◽  
Opioid Analgesics ◽  
Dental Pain ◽  
Opioid Analgesia ◽  
Dental Practice ◽  
Opioid Use ◽  
Safety And Efficacy ◽  
Post Operative Pain ◽  
The Us ◽  
The Uk

The use and misuse of opioid analgesics have been highlighted in recent years. This review assesses dental opioid use, the effectiveness of opioid-containing analgesics versus non-opioid alternatives and the implications for post-operative pain management strategies in the dental practice. Guidelines for the management of acute post-operative dental pain differ from country to country. The UK has a low dental opioid use rate when compared to the US. The combination of paracetamol and ibuprofen has similar, if not better, analgesic properties compared to opioid-containing alternatives, with fewer adverse effects. CPD/Clinical Relevance: Non-opioid analgesics are both a safe and effective alternative to opioid analgesics in the management of post-operative dental pain.

Introduction

2019 ◽  
pp. 1-11
Author(s):  
Nick Mansfield
Keyword(s):  
Nineteenth Century ◽  
Working Class ◽  
British Empire ◽  
Industrial Revolution ◽  
British Society ◽  
Popular Politics ◽  
Subsequent Growth ◽  
Working Lives ◽  
Primary Means ◽  
The Uk

In common with its companion volume - Soldiers as Workers – Class, employment, conflict and the nineteenth century military (2016), this study argues that class is the primary means of understanding the topic. Focusing on rank and file soldiers it concludes that they were not a separate caste. Instead, soldiering was often just a phase in civilian working lives. The nineteenth century was overshadowed by the mass mobilisation required for the generation-long French Wars and concurrent Industrial Revolution, with emerging working-class popular politics. The chapter reviews developing working class literacy and subsequent growth of rank and file memoirs, which are an important source for this study. The chapter stresses the importance of the new barrack system in the UK and the growth of British Empire, both of which had profound consequences for British society.

Conclusion

2020 ◽  
pp. 201-206
Author(s):  
Lucy Atkinson ◽  
Andrew Blick ◽  
Matt Qvortrup
Keyword(s):  
Nineteenth Century ◽  
Natural Extension ◽  
The Political ◽  
The Public ◽  
The People ◽  
Popular Government ◽  
Political Spectrum ◽  
Device Use ◽  
The Uk ◽  
Working Device

The referendum came onto the agenda in the UK in the final quarter of the nineteenth century, and it has never entirely disappeared from it, either as a proposition or a working device. Use of the referendum in the UK was conceived of and presented both as a natural extension of the principle of democracy that was then taking hold, and as a means of offsetting perceived defects with the representative variant of popular government that had developed. In particular, it was seen as a safeguard against the manipulative impact of parties that might lead the parliamentary system to serve the ends of factions within the elite above the people. It might enable the public to vote for a particular party with which they were broadly sympathetic without needing to endorse their entire programme; and would mean that a government could not implement measures of major significance to which a majority objected. It was largely envisaged as likely to have a conservative impact, creating a new and final means by which change might be blocked. Yet its appeal spread across the political spectrum; as did opposition to it....

The Incomes of the Plutocrats in a Comparative Perspective

2021 ◽  
pp. 152-171
Author(s):  
Francis Teal
Keyword(s):  
Nineteenth Century ◽  
Income Distribution ◽  
Comparative Perspective ◽  
Average Wage ◽  
Male Character ◽  
Pride And Prejudice ◽  
The Us ◽  
The Rich ◽  
The Uk

We now move to examine the top of the income distribution and begin by asking whether Mr Darcy, the central male character in Jane Austen’s novel Pride and Prejudice, would be regarded as a plutocrat today. If his income were converted to contemporary amounts it would be some £600,000. We show that Mr Darcy would need to earn some £8 million to be as rich as his nineteenth-century predecessor relative to the average wage. To understand how those super-high incomes arise, we introduce the Paretian distribution which we do first informally and then more formally. It is a distribution of this form which could produce what we see, a few very highly paid individuals whose incomes—up in the stratosphere of the super-rich—would still be very spread out. We use the Paretian distribution to estimate the number of plutocrats in the US, the UK, and China and show the incomes of the richest of the rich.

The NICE Guidelines and Pediatric Sedation in the United Kingdom

2018 ◽  
pp. 306-312
Author(s):  
Michael Sury ◽  
Sarah Greenaway
Keyword(s):  
United Kingdom ◽  
National Health Service ◽  
Clinical Excellence ◽  
Nice Guidelines ◽  
Safety And Efficacy ◽  
Government Organization ◽  
The United Kingdom ◽  
Pediatric Sedation ◽  
Consensus View ◽  
The Uk

Pediatric procedural sedation is required for children across the globe in a wide variety of circumstances. In the United Kingdom, the National Institute for Health and Clinical Excellence (NICE) is a government organization whose purpose is to provide guidelines to help ensure that patients receive effective, good-value healthcare across the whole of the National Health Service. In 2010 NICE published a guideline for the use of pediatric sedation. The overarching aims were to review the safety and efficacy of sedation for common procedures and to form a consensus view on the necessary resources to do this safely. This chapter summarizes the key recommendations and describes how pediatric sedation has since evolved in the UK.

2. Copyright 1: history, rationale, and policy context

2019 ◽  
pp. 31-50
Author(s):  
Abbe Brown ◽  
Smita Kheria ◽  
Jane Cornwell ◽  
Marta Iljadica
Keyword(s):  
Nineteenth Century ◽  
Historical Development ◽  
New Technologies ◽  
Rapid Development ◽  
Copyright Law ◽  
Policy Context ◽  
Law And Policy ◽  
Legal Frameworks ◽  
The Uk ◽  
The Eu

This chapter considers the evolution of modern copyright law against the background of its historical development in the UK and the international and European legal frameworks within which UK copyright law has been increasingly set since the nineteenth century. It examines the rationale and justifications for copyright and identifies the general policy context within which law and policy has developed in the UK and the EU. It also highlights the rapid development of new technologies which has brought copyright reform to the forefront in recent times, the difficulties which this new environment presents for the copyright framework, and how the framework has developed to such challenges.

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