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Article
Publication date: 29 March 2013

Beth Ann Fiedler, Robert J. Bebber and Reid M. Oetjen

Global health objectives have stimulated changes to the international vaccine market. The authors seek to suggest that modern vaccine categories will aid in the formation of…

Abstract

Purpose

Global health objectives have stimulated changes to the international vaccine market. The authors seek to suggest that modern vaccine categories will aid in the formation of standardized clinical trial processes through the implementation of suggested policy strategies.

Design/methodology/approach

A systematic review of literature for the period of 2000‐2010 was conducted by searching academic databases of peer‐reviewed articles (e.g. Medline, PsychInfo, and Social Science Citation Index) for multiple keywords, namely: clinical trial, regulatory standards, vaccine development, vaccine manufacturing, and vaccine distribution. The search yielded surprisingly few items that were able to provide an adequate baseline of clinical trial processes for fundamental analysis. Consequently, additional material was obtained through an exploratory literature review. The method included hand‐searching reference lists and tables of contents and search engines (Google Scholar) for national and international clinical trial regulatory processes, global health organizations, and trends in vaccine marketing.

Findings

Establishing modern vaccine designations is essential towards addressing the current trends of vaccine development. Identification of the market drivers will aid in the goal of establishing international protocols that can better position industry to streamline response in several areas including research, economic development, manufacturing, and distribution.

Practical implications

Categorization of modern vaccine development can guide the international formulation of manufacturing and distribution policy strategies to elicit a cross‐cultural global delivery system.

Originality/value

This paper contributes to academic literature threefold. It categorizes vaccines, depicts the fundamental clinical trial phases vital to global health, and provides policy options driven by modern vaccine production designations.

Details

International Journal of Pharmaceutical and Healthcare Marketing, vol. 7 no. 1
Type: Research Article
ISSN: 1750-6123

Keywords

Article
Publication date: 4 September 2017

Norman W. Baylor

Before vaccines are marketed and used, they must be evaluated and approved by a national regulatory authority (NRA). The Food and Drug Administration (FDA) is the NRA in the USA…

Abstract

Purpose

Before vaccines are marketed and used, they must be evaluated and approved by a national regulatory authority (NRA). The Food and Drug Administration (FDA) is the NRA in the USA responsible for overseeing and regulating the manufacturing, marketing, and distribution of vaccines. The paper aims to discuss this issue.

Design/methodology/approach

Expert review.

Findings

Developed countries have established governmental regulatory agencies to review and determine the safety and effectiveness of vaccines to ensure that the manufacture, sale, and use of vaccines are adequately regulated. However, even today, many developing countries do not have established NRAs. Furthermore, despite similarities, there are still substantial differences in how regulatory authorities in different countries perform minimum functions required for effective regulation of pharmaceutical products, including vaccines. The World Health Organization (WHO), although not a governmental NRA, uses a consultative approach involving its Expert Committee on Biological Standardization and Biologicals Unit to develop regulatory criteria and identify and consolidate current consensus opinions on key regulatory issues. It is through this approach that WHO informs NRAs on the necessary scientific background required to assess and advise on optimal regulatory approaches and methodologies. This paper will focus on the evolution of the US FDA and its role in regulation of vaccines to illustrate the function of a vaccine NRA.

Originality/value

Vaccines are an important resource for protecting people and communities from the mortality and morbidity associated with many infectious diseases. The assessment, licensure, control and surveillance of vaccines are the responsibilities of government regulatory authorities.

Content available
1291

Abstract

Details

International Journal of Pharmaceutical and Healthcare Marketing, vol. 7 no. 1
Type: Research Article
ISSN: 1750-6123

Abstract

Details

Virus Outbreaks and Tourism Mobility
Type: Book
ISBN: 978-1-80071-335-2

Book part
Publication date: 30 June 2017

Jennifer A. Reich

Public health programs facilitate access to resources that not only provide individuals’ options but also often foreclose individual preference through prescriptive requirements…

Abstract

Public health programs facilitate access to resources that not only provide individuals’ options but also often foreclose individual preference through prescriptive requirements. This chapter takes two disparate cases from public health – vaccines and family planning –that reveal patterns of inequality in who has access to individual choice and who requires state support to exercise choice. Looking specifically at dynamics of funding and compulsion, this chapter elucidates how reliance on the rhetoric of individual choice as an expression of freedom rewards those with the greatest access to resources and fails to make sure that all members of the community have the resources to shape their own outcomes or to make sure collective health is protected.

Details

Studies in Law, Politics, and Society
Type: Book
ISBN: 978-1-78714-811-6

Keywords

Article
Publication date: 29 December 2023

Ashu Lamba, Priti Aggarwal, Sachin Gupta and Mayank Joshipura

This paper aims to examine the impact of announcements related to 77 interventions by 46 listed Indian pharmaceutical firms during COVID-19 on the abnormal returns of the firms…

Abstract

Purpose

This paper aims to examine the impact of announcements related to 77 interventions by 46 listed Indian pharmaceutical firms during COVID-19 on the abnormal returns of the firms. The study also finds the variables which explain cumulative abnormal returns (CARs).

Design/methodology/approach

This study uses standard event methodology to compute the abnormal returns of firms announcing pharmaceutical interventions in 2020 and 2021. Besides this, the multilayer perceptron technique is applied to identify the variables that influence the CARs of the sample firms.

Findings

The results show the presence of abnormal returns of 0.64% one day before the announcement, indicating information leakage. The multilayer perceptron approach identifies five variables that explain the CARs of the sample companies, which are licensing_age, licensing_size, size, commercialization_age and approval_age.

Originality/value

The study contributes to the efficient market literature by revealing how firm-specific nonfinancial disclosures affect stock prices, especially in times of crisis like pandemics. Prior research focused on determining the effect of COVID-19 variables on abnormal returns. This is the first research to use artificial neural networks to determine which firm-specific variables and pharmaceutical interventions can influence CARs.

Details

International Journal of Pharmaceutical and Healthcare Marketing, vol. ahead-of-print no. ahead-of-print
Type: Research Article
ISSN: 1750-6123

Keywords

Book part
Publication date: 3 May 2022

Jinan Issa

The path to academic excellence is neither paved with roses nor easy; nonetheless, cautiously driving such a road has endless thrills especially when the driver is passionate…

Abstract

The path to academic excellence is neither paved with roses nor easy; nonetheless, cautiously driving such a road has endless thrills especially when the driver is passionate about academia. This chapter intends to bring to the fore the hurdles I have been confronting in my academic path as an international scholar and a researcher in some of the Middle East and North Africa (MENA) countries, Malaysia and Canada (Global North and South institutions) for over 14 years. Hence, it mirrors my research experiences to guide Early Career Researchers (ECRs) and accentuates the importance of research culture, professional designations and networking with experts from other world knowledge bodies.

Details

Academic Mobility and International Academics
Type: Book
ISBN: 978-1-80117-510-4

Keywords

Expert briefing
Publication date: 27 August 2021

Brazil, one of the hardest-hit countries, has a long history of policy and practice aimed at matching universal healthcare with sustainable local supply. Successful technological…

Details

DOI: 10.1108/OXAN-DB263756

ISSN: 2633-304X

Keywords

Geographic
Topical
Article
Publication date: 21 June 2013

Beth Ann Fiedler and Robert J. Bebber

The purpose of this paper is to establish historic regulatory conditions and priority national characteristics eliciting outstanding best practices in clinical trial regulatory…

Abstract

Purpose

The purpose of this paper is to establish historic regulatory conditions and priority national characteristics eliciting outstanding best practices in clinical trial regulatory systems, towards global health objectives through targeted economic development.

Design/methodology/approach

Exploratory review of clinical trial processes of three industrialized nations with similar democratic processes – Japan, the UK and the USA – in order to determine the efficacy of international clinical trials.

Findings

Outstanding best practices in national vaccine clinical trials can guide the international economic development, manufacturing and distribution policy strategies necessary to form the basis of a cross‐cultural global delivery system.

Originality/value

This study's contribution to academic literature is threefold: first, it reviews established fundamental clinical trial processes for Japan, the UK and the USA; second, it distinguishes similarities and differences to determine best practices; and third, it suggests changes in regulatory vaccine clinical trials towards achieving global health objectives.

Details

International Journal of Pharmaceutical and Healthcare Marketing, vol. 7 no. 2
Type: Research Article
ISSN: 1750-6123

Keywords

Book part
Publication date: 2 August 2016

William H. Kitchens

This chapter focuses on the regulatory scheme used by the United States Food and Drug Administration (FDA) to approve medical products for commercial use in this country. After…

Abstract

This chapter focuses on the regulatory scheme used by the United States Food and Drug Administration (FDA) to approve medical products for commercial use in this country. After providing a brief introduction of the role of the FDA and the scope of the products regulated by the agency, the chapter outlines the common characteristics of premarket controls for drugs, medical devices, and biological products, including how clinical trials of these medical products are conducted with humans as part of the premarket approval process. The chapter then provides a detailed examination of the particular regulatory scheme for each product category. The chapter concludes with an analysis of how FDA regulates emerging medical technologies, such as cellular and tissue-engineered products. FDA regulates a variety of products intended to diagnose, cure, mitigate, treat, or prevent diseases or conditions under a legal scheme established in the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act and regulations promulgated by FDA. How a product is classified (drug, device, or biologic) forecasts the regulatory approval pathway that must be followed to bring the product to market. This chapter provides education and direction regarding regulatory requirements that must be met to market medical products in the United States.

Details

Technological Innovation: Generating Economic Results
Type: Book
ISBN: 978-1-78635-238-5

Keywords

1 – 10 of 151