Changes In Regulatory Environment Research Articles

Drug delivery trends for parenteral therapeutics

Drug delivery technologies for reformulation of parenteral therapeutics has received a lot of attention in recent years, due to significant advances in the field. There is a growing need for patient compliant dosage forms within the cancer therapeutics and biotechnology areas. Besides patient compliance, ease of administration, enhanced therapeutic efficacy, and reduced side effects, are additional factors that differentiate drug delivery products from conventional dosage forms, thus providing a competitive advantage.This article reviews some salient trends in the parenteral drug delivery sector, within the realms of a changing regulatory environment. Drivers to growth as well as recent advances in this field have been reviewed. Finally, challenges associated with bringing parenteral drug delivery concepts to commercialization have also been discussed.

The Shifting Meaning of Mutuality and Co-Operativeness in the Credit Union Movement from 1959 to 1989

By studying the way that a peak industry association used its newsletter to interpret change in the broader social, political and economic context for their member organisations, we find how these texts sought to unite an increasingly fragmented group of organisations as well as to reinforce the role and identity of the association. We observe the connections between discourse and the organisational identity of the New South Wales (NSW) Credit Union Association, formerly the NSW Credit Union League. As a peak industry body they represent the interests of a range of credit unions in NSW. This article examines the newsletters of the peak industry association across four key time periods, from the economic and political stability of the late 1950s through to the economic turbulence and changing regulatory environment of the 1980s. Through historically situated discursive analysis, we highlight the connections between the changing social and political context and the shifting meaning of the credit union's core values of co-operation and mutuality.

The evolution of annual reporting practices of an electricity firm

Accounting both influences and is influenced by the environment in which it operates. We examine how this interaction takes place in a changing regulatory environment with particular emphasis on the influence on accounting policies and practices. Using a longitudinal study from 1988 to 2001, we analysed six major events representing changes in the regulations governing the operations of an electricity firm in New Zealand. We provide evidence which suggests that those changes influenced the choice of accounting policies and reporting practices of the case organisation. We also found evidence to suggest that accounting was used to influence the regulatory environment and as rhetoric in supporting a new ideology, which is market-oriented and profit driven.

Public opinion toward the first, second, and third generations of plant biotechnology

Abstract This paper considers public attitudes toward genetically modified plants in the fields or those soon to be planted. Analyzing a regional public opinion survey of 680 respondents in Arkansas, Texas, Louisiana, New Mexico, and Oklahoma carried out in the Spring–Summer of 2004, we look at the importance of public attitudes toward the three generations of agricultural biotechnology in light of the changing regulatory environment. Specifically, we ask questions concerning the first generation of plants with agronomic qualities, comparing our findings with previous studies, then look at perceptions of the second generation of crops with product quality characteristics, and the third generation, which expresses industrial products and pharmaceutical drugs. We look at perceived benefits, the likelihood, that these plants might accidentally enter the food supply, the likelihood that these plants might be eaten by the respondent, as well as how worried and angry the respondent would be as a result. Finding...

Container Railfreight Services in North‐west Europe: Diversity of Organizational Forms in a Liberalizing Environment

The institutional environment of rail transport has changed as a result of recent European directives, but the changes have taken different forms from one country to another. In the case of international maritime chains, the development of door‐to‐door services makes inland haulage from the loading and discharging ports extremely important, and it highlights the need to reshape the rail freight industry. This paper analyses the degree of involvement of different actors drawn from the maritime industry in developing and commercializing rail services in the changing regulatory environment. Several maritime operators, shipping lines, port‐handling companies and port authorities have been involved in some container rail services since the early days of liberalization. Their commitments take very different forms, however. Whereas contracts are mainly used for the provision of service, particularly for train haulage, integration by means of shareholding or creating subsidiaries or joint ventures is used for marketing. Important differences between France, the UK, Germany and the Netherlands are detailed. In the latter two countries, there is more involvement in the provision of rail services. Marketing rail services appear to be the main strategic issue for the maritime operators in all four countries

Deregulation, governance structures, and efficiency: the U.S. electric utility sector

The business strategy literature offers apparently opposite views of the ability of vertical integration to cope with the uncertainty related to changing regulatory environments. In this paper, we analyze how the process of retail deregulation affects the comparative efficiency of governance structures, which range on a continuum from fully vertically integrated structures to market transactions. Based on the analysis of 177 U.S. electric utilities from 1998 to 2001, our results show that the process of retail deregulation has a negative impact on firms' productive efficiency, as measured using Data Envelopment Analysis. Furthermore, firms that are vertically integrated into electricity generation, or that rely on the market for the supply of their electricity, are more efficient than firms that adopt hybrid structures combining vertical integration and contracting. This research has important implications because it shows the coexistence of different types of governance structures that cope efficiently with regulatory uncertainty through different mechanisms. Copyright © 2005 John Wiley & Sons, Ltd.

Managing Competition Through Barriers to Entry and Channel Availability in the Changing Regulatory Environment

In this article, we explore factors that influence the number of broadcasters in a market and the achievement of optimal outcomes in broadcast markets.We explore a range of barriers to entry and means of overcoming those barriers in broadcast markets.We argue that choices regarding and influences on barriers to entry and channel availability act as forms of competition management in broadcast markets. Policymakers and regulators indirectly influence markets by altering the effects of those barriers and directly influence market activities by making decisions regarding the number of competitors, market structures,and-indirectly-the financial performance of broadcasters. We argue that barriers to entry can be controlled to produce competition levels and market outcomes that promote optimal social and economic outcomes.

Managing Competition Through Barriers to Entry and Channel Availability in the Changing Regulatory Environment

Managing Competition Through Barriers to Entry and Channel Availability in the Changing Regulatory Environment

Bank Mergers Under a Changing Regulatory Environment

Over the last 30 years, American banks transformed their organization through mergers and concentration. Which organizational theory better fits banks' responses to the four distinctive regulatory policy environments they faced over these years? An event-history analysis of mergers suggests that resource-dependence theory has a better overall fit than organizational ecology theory. However, the balance of influence shifted from external environmental causes toward internal organizational causes as deregulation created competitive pressures. Organizational efficiency had little bearing on the likelihood of a bank's being involved in a merger.

Green electricity policies in the United States: case study

While there has been interest in promoting the use of renewable energy in electricity production for a number of years in the United States, the market share of non-hydro renewable energy sources in electricity production has remained at about 2 percent over the past decade. The paper reviews the principal energy resources used for electricity production, considers the changing regulatory environment for the electricity industry, and describes government policies that have been used to promote green electricity in the United States, with an emphasis on measures adopted by state governments. Factors influencing the development of green power markets are also discussed, including underlying economic issues, public policy measures, the regulatory environment, external costs, and subsidies. Without significant increases in fossil fuel prices, much more stringent environmental regulations, or significant changes in electricity customer preferences, green electricity markets are likely to develop slowly in the United States.

The Changing Regulatory Environment for Speculative Housebuilding and the Construction of Core Competencies for Brownfleld Development

Speculative housebuilding in the United Kingdom faces an ever tighter regulatory environment owing to the increasing impact of the sustainable development agenda. For example, 60% of all new homes in England are now expected to be constructed on previously developed land or provided through the conversion of existing buildings. As speculative housebuilders are responsible for about 80% of all new dwellings built in the United Kingdom, the achievement of this important government target is critically dependent on the ability and willingness of the private sector to respond to public policy. By exploring the main components of the residential development process, the author investigates how far speculative housebuilding will need to change to ensure the successful implementation of the government's brownfield housing target. He suggests that those speculative housebuilders that are enthusiastically building up core competencies in brownfield housing are likely to emerge as the market leaders of the future whereas those companies that continue to rely on past practices and technologies will face an uncertain future as greenfield development opportunities begin to reduce.

French insurance from the ancien régime to 1946: shifting frontiers between state and market

This article considers the changing regulatory environment in which French insurance operated between the ancien régime and the post-war years. At first treated with suspicion, the state came to recognise the social benefits of insurance during the industrial revolution. The extension of regulation over different products and companies – life, marine, general – needs to be understood as a historical process in which first the benefits and then the possibilities for access to substantial financial resources came to be understood. A dual tradition of mistrust and fascination has prevailed in the French attitudes towards insurance, and this paper explores this relationship in a variety of contexts. It is suggested that the eventual nationalisation of much of the industry in 1946 was a signal of both increasing respectability and of the state's desire to offer universal coverage. The opportunity to mobilise and direct investment flows was also attractive.

Simulating coalitionally stable burden sharing agreements for the climate change problem

The CLIMNEG world simulation (CWS) model is introduced here for simulating cooperative game theoretic aspects of global climate negotiations. The CWS model is derived from the seminal RICE model by Nordhaus and Yang [Am. Econ. Rev. 86 (1996) 741]. We first state the necessary conditions that determine Pareto efficient investment and emission abatement paths under alternative regimes of cooperation between the regions. We then show with a numerical version of the CWS model that the transfer scheme advocated by Germain et al. [M. Germain, P.L. Toint, H. Tulkens, Financial transfers to ensure international optimality in stock pollutant abatement, in: F. Duchin, S. Faucheux, J. Gaudy, I. Nicolaı̈ (Eds.), Sustainability and Firms: Technological Change and Changing Regulatory Environment, Edward Elgar, Celtenham, UK, 1997] induces an allocation in the (“gamma”) core of the world carbon emission abatement cooperative game.

Emissions from fuel combustion in Swedish cod fishery : Ziegler, F. and Hansson, P.-.A. Journal of Cleaner Production, 2003, 11, (3), 303–314

The Tennessee Valley Authority (TVA), created by Act of Congress in 1933, has responsibility for generating electricity, providing flood control, and promoting agricultural and industrial development for the Tennessee Valley. In the generation of electricity, TVA initially developed extensive hydroelectric facilities throughout the valley and, subsequently, extensive fossil and nuclear facilities. In the changing regulatory and economic environment associated with electricity generation, TVA has created the Public Power Institute (PPI). The PPI has responsibility for advancing energy generation and pollution reduction; it has responsibility for renewable energy development. In carrying out its renewable energy commitment, the PPI extends the leadership in biomass cofiring started in 1992, with studies and testing performed in cooperation with the Electric Power Research Institute at such locations as the Kingston Fossil Plant and the Allen Fossil Plant. It extends the activities associated with using tire-derived fuel at the Allen Fossil Plant. Through the PPI, TVA will continue to take a leadership role in the development of biomass systems.

Deregulation Process, Governance Structures and Efficiency: The U.S. Electric Utility Sector

This paper is an empirical assessment of the comparative efficiency of governance structures in an environment marked by high uncertainty. We analyze the short-term impact of retail deregulation on the productive efficiency of electric utilities in the United States. We argue that there are transitory costs linked to the process of deregulation. The business strategy literature suggests different governance structures to cope with uncertainty linked to changing regulatory environments. Transaction cost economics suggests that firms may reduce their exposure to the uncertainty created by the process of deregulation by adopting vertical integration strategies. Organizational scholars on the contrary argue that firms vertically disintegrate and adopt flexible governance structures to increase their adaptability to the new conditions. Our empirical analysis is based on 177 investor-owned electric utilities representing 83% of the total U.S. electricity production by utilities from 1998-2001. Our results show that the process of deregulation has a negative impact on firms' productive efficiency measured using Data Envelopment Analysis. However, firms that are vertically integrated into electricity generation or that rely on the market for the supply of their electricity are more efficient than firms that adopt hybrid structures combining vertical integration and contracting.

Towards a flexible deployment of business rules

Abstract Business rules give rise to an important set of requirements on any system being developed or procured for an enterprise. While most of the work done in this area focuses on identifying and documenting business rules, we have proposed a methodology that addresses several aspects of the business rules lifecycle: acquisition, deployment and evolution. The methodology assumes that business rules are expressed in terms of business concepts and corporate knowledge that are captured in a high level architecture. The architecture proposed consists of three interconnected components: the enterprise model, the business rules model and the decision support model. This approach permits a greater variety of rules to be specified while providing an opportunity to automate the production of deployable business rules. The ability to deal with the inconsistent and ambiguous rules is crucial in capturing the conflicting requirements placed on the operation of any large scale enterprise. This paper presents a flexible deployment of business rules, which not only supports decision making in the face of conflicting requirements, but also the evolution of those requirements in the face of changing regulatory environments, competitive markets and corporate goals.

Managing Credit Risk: A Challenge for the New Millennium

The importance of credit–risk management has never been more important with the current high default rates and bankruptcies; but, there was heightened interest even before the current scenario. Indeed, in 1999, at the end of the benign credit cycle, banks, regulators, and financial market practitioners were spending considerable time on this subject due to:(1) Increased emphasis on sophisticated risk management techniques in a changing regulatory environment – mainly revisions to the so–called ‘Basel Accord’(2) Refinements in credit–scoring techniques(3) Establishment of relatively large, relevant data bases on defaults, recoveries and credit migrations(4) Treatment of bank loans as securities(5) Development of ‘offensive’ credit–risk mitigation techniques such as securitizations, credit derivatives and credit insurance products(6) Portfolio management techniques for credit assets.(J.E.L.: G14, G21, G33).

REGULATORY ENVIRONMENT IN THE ADVERTISING OF DIETARY SUPPLEMENTS

ABSTRACTThis paper discusses the advertising of dietary supplements and the changing regulatory environment. The role of the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) in regulating dietary supplements will be reviewed with emphasis on issues concerning utilizing data to establish advertising claims.

Networks of Corporate Interlocking: 1962—1995

This paper documents the changing patterns of corporate interlocking among approximately 250 corporations across four time periods—1962, 1973, 1983, and 1995. By utilizing network analyses, we describe several attributes of the overall set of interlocking corporate directors in a period of increasing corporate concentration, economic globalization, and changing regulatory environments. Measures of network density are based on all corporations and are broken-down by the ties formed by single versus multiple interlocking directorates. Three measures of network centralization are based on complete sociomatricies in which all ties between corporations are non-directional and have been recorded as either present or absent. Finally, we report the number of cliques formed by minimum size across time. Measures of network density, centralization and the number of cliques all underscore that the network of corporate ties in 1995 is less dense, less concentrated, and contain few subgroups. Our analyses at the corporate level demonstrate that these changes occurred primarily among financial corporations and correspond to a period of dramatic changes in the U.S. financial markets. Given our descriptive findings, we conclude that interlocking directorates in the United States are becoming less concentrated, though by no means insignificant.

BIOPHARMACEUTICAL STATISTICS IN A PHARMACEUTICAL REGULATED ENVIRONMENT: PAST, PRESENT, AND FUTURE

The practice of statistics in the pharmaceutical industry has changed markedly over the last 25 years. This paper examines the evolution of clinical trial statistics in relationship to advances in statistical methodology and computational power as well as the changing regulatory environment. The current role of the biopharmaceutical statistician is assessed along with the drivers for future change.