A SURVEY OF THE LIKELIHOOD APPROACH TO BIOEQUIVALENCE TRIALS

Bioequivalence trials are abbreviated clinical trials whereby a generic drug or new formulation is evaluated to determine if it is "equivalent" to a corresponding previously approved brand-name drug or formulation. In this manuscript, we survey the process of testing bioequivalence and advocate the likelihood paradigm for representing the resulting data as evidence. We emphasize the unique conflicts between hypothesis testing and confidence intervals in this area - which we believe are indicative of the existence of the systemic defects in the frequentist approach - that the likelihood paradigm avoids. We suggest the direct use of profile likelihoods for evaluating bioequivalence and examine the main properties of profile likelihoods and estimated likelihoods under simulation. This simulation study shows that profile likelihoods are a reasonable alternative to the (unknown) true likelihood for a range of parameters commensurate with bioequivalence research. Our study also shows that the standard methods in the current practice of bioequivalence trials offers only weak evidence from the evidential point of view.

Building an Academic Cloud for 500,000 Users

Under the brand name “sciebo – the Campuscloud” (derived from “science box”) a consortium of more than 20 research and applied science universities started a large scale cloud service for about 500,000 students and researchers in North Rhine-Westphalia, Germany’s most populous state. Starting with the much anticipated data privacy compliant sync & share functionality, sciebo offers the potential to become a more general cloud platform for collaboration and research data management which will be actively pursued in upcoming scientific and infrastructural projects. This project report describes the formation of the venture, its targets and the technical and the legal solution as well as the current status and the next steps.

A CONFLITUOSA RELAÇÃO DAS ASSEMBLEIAS DE DEUS BRASILEIRAS E A TELEVISÃO: DA PROIBIÇÃO À ACEITABILIDADE

Esta pesquisa busca abordar e analisar os caminhos da mídia televisiva nas igrejas Assembleias de Deus no Brasil, aqui trabalhadas no plural devido às muitas ramificações da denominação, em suas construções das representações simbólicas, imaginárias, culturais e midiáticas. O objetivo é analisar a dimensão simbólica na proibição do uso da televisão na denominação religiosa em questão, e os argumentos para o veto entre os fiéis, a discreta aceitabilidade da TV diante das novas concepções teológicas das ADs ao longo dos anos, investimento em canal aberto (Rede Boas Novas de Televisão) e proposta de um programa televisivo como marca midiática da denominação (Programa Movimento Pentecostal). Para viabilidade desse trabalho, a metodologia adotada consiste em pesquisa bibliográfica histórica, com foco nos temas fundamentais para o desenvolvimento das pesquisas do imaginário, identidade, cultura, nação e televisão, aliada à pesquisa documental, que tem como meta os registros históricos, que melhor elucidarão os caminhos e a ligação da TV com as Assembleias de Deus.

Minority enterprise in the clothing industry: an analysis of Asian jeans manufacturers in Birmingham

This thesis discusses and assesses the resources available to Asian entrepreneurs in the West Midlands' clothing industry and how they are used by these small businessmen in order to address opportunities in the market economy within the constraints imposed. The fashion industry is volatile and is dependent upon flexible firms which can respond quickly to shortrun production schedules. Small firms are best able to respond to this market environment. Production of jeans presents an interesting departure from the mainstream fashion industry. It is traditionally gared towards longrun production schedules where multinational enterprises have artificially diversified the market, promoting the 'right' brand name and have established control of the upper end of the market, whilst imports from Newly Developing Countries have catered for cheap copies at the lower end of the market. In recent years, a fashion element to jeans has emerged, thus opening a market gap for U.K. manufacturers to respond in the same way as for other fashion articles. A large immigrant population, previously serving the now declining factories and foundries of the West Midlands but, through redundancy, no longer a part of this employment sector, has ~5ponded to economic constraints and market opportunities by drawing on ethnic network resources for competitive access to labour, finance and contacts, to attack the emergent market gap. Two models of these Asian entrepreneurs are developed. One being somecne who has professionally and actively tackled the market gap and become established. These entrepreneurs are usually educated and have personal experience in business and were amongst the first to perceive opportunities to enter the industry, actively utilising their ethnicity as a resource upon which to draw for favorable access to cheap, flexible labour and capital. The second model is composed of later entrants to jeans manufacturing. They have less formal education and experience and have been pushed into self-employment by constraints of unemployment. Their ethnicity is passively used as a resource. They are more likely confined to the marginal activity of 'cut make and trim' and have little opportunity to increase profit margins, become estalished or expand.

The influence of face and group orientation on the perception of luxury goods:a four market study of East Asian consumers

Purpose: The paper aims to further extend our understanding by assessing the extent to which two prominent cultural values in East Asia i.e. face saving and group orientation drive consumers' perceptions of luxury goods across four East Asian markets. Design/methodology/approach: A multi-methods research approach was adopted consisting of: an expert panel of close to 70 participants, group discussions with five extended East Asian families, personal interviews with eight East Asian scholars, a pilot test with over 50 East Asian graduate students and a multi-market survey of 443 consumer respondents in Beijing, Tokyo, Singapore and Hanoi. Findings: The authors extend previous conceptual studies by empirically investigating the impact of these two cultural values on the perception of luxury among East Asian societies. Specifically the study reveals that across all four markets face saving has the strongest influence on the conspicuous and hedonistic dimensions of luxury, group orientation meanwhile is the strongest predictor of the quality, extended self and exclusivity dimensions of luxury. Collectively these two cultural values significantly influence East Asian perceptions of luxury. Overall, the findings reiterate the importance of understanding different cultural values and their influence across different East Asian societies. Practical implications: The findings have important implications for managers of western luxury branded goods that are seeking to penetrate East Asian markets or seek to serve East Asian consumers. Specifically, to assist with developing suitable brand positioning, products, services, communications and pricing strategies. Originality/value: This study contributes to our understanding of the subject by exploring the impact of face saving and group orientation on the perception of luxury goods across four East Asian countries. Several directions for future research are suggested. © Emerald Group Publishing Limited.

An empirical analysis of the global audit market: International Financial Reporting Standards-related changes and differences within the Big 4 global networks

Ongoing debates within the professional and academic communities have raised a number of questions specific to the international audit market. This dissertation consists of three related essays that address such issues. First, I examine whether the propensity to switch between auditors of different sizes (i.e., Big 4 versus non-Big 4) changes as adoption of International Financial Reporting Standards (IFRS) becomes a more common phenomenon, arguing that smaller auditors have an opportunity to invest in necessary skills and training needed to enter this market. Findings suggest that clients are relatively less (more) likely to switch to (away from) a Big 4 auditor if the client's adoption of IFRS occurs in more recent years. ^ In the second essay, I draw on these inferences and test whether the change in audit fees in the year of IFRS adoption changes over time. As the market becomes less concentrated, larger auditors becomes less able to demand a premium for their services. Consistent with my arguments, results suggest that the change in audit service fees declines over time, although this effect seems concentrated among the Big 4. I also find that this effect is partially attributable to a differential effect of the auditors' experience in pricing audit services related to IFRS based on the period in which adoption occurs. The results of these two essays offer important implications to policy debates on the costs and benefits of IFRS adoption. ^ In the third essay, I differentiate Big 4 auditors into three classifications—Parent firms, Brand Name affiliates, and Local affiliates—and test for differences in audit fee premiums (relative to non-Big 4 auditors) and audit quality. Results suggest that there is significant heterogeneity between the three classifications based on both of these characteristics, which is an important consideration for future research. Overall, this dissertation provides additional insights into a variety of aspects of the global audit market.^

Essays on Competition in the Pharmaceutical Industry

Chapter 1: Patents and Entry Competition in the Pharmaceutical Industry: The Role of Marketing Exclusivity Effective patent length for innovation drugs is severely curtailed because of extensive efficacy and safety tests required for FDA approval, raising concern over adequacy of incentives for new drug development. The Hatch-Waxman Act extends patent length for new drugs by five years, but also promotes generic entry by simplifying approval procedures and granting 180-day marketing exclusivity to a first generic entrant before the patent expires. In this paper we present a dynamic model to examine the effect of marketing exclusivity. We find that marketing exclusivity may be redundant and its removal may increase generic firms' profits and social welfare. Chapter 2: Why Authorized Generics?: Theoretical and Empirical Investigations Facing generic competition, the brand-name companies some-times launch generic versions themselves called authorized generics. This practice is puzzling. If it is cannibalization, it cannot be profitable. If it is divisionalization, it should be practiced always instead of sometimes. I explain this phenomenon in terms of switching costs in a model in which the incumbent first develops a customer base to ready itself against generic competition later. I show that only sufficiently low switching costs or large market size justifies launch of AGs. I then use prescription drug data to test those results and find support. Chapter 3: The Merger Paradox and R&D Oligopoly theory says that merger is unprofitable, unless a majority of firms in industry merge. Here, we introduce R&D opportunities to resolve this so-called merger paradox. We have three results. First, when there is one R&D firm, that firm can profitably merge with any number of non-R&D firms. Second, with multiple R&D firms and multiple non-R&D firms, all R&D firms can profitably merge. Third, with two R&D firms and two non-R&D firms, each R&D firms prefer to merge with a non-R&D firm. With three or more than non-R&D firms, however, the R&D firms prefer to merge with each other.

A CONFLITUOSA RELAÇÃO DAS ASSEMBLEIAS DE DEUS BRASILEIRAS E A TELEVISÃO: DA PROIBIÇÃO À ACEITABILIDADE

Esta pesquisa busca abordar e analisar os caminhos da mídia televisiva nas igrejas Assembleias de Deus no Brasil, aqui trabalhadas no plural devido às muitas ramificações da denominação, em suas construções das representações simbólicas, imaginárias, culturais e midiáticas. O objetivo é analisar a dimensão simbólica na proibição do uso da televisão na denominação religiosa em questão, e os argumentos para o veto entre os fiéis, a discreta aceitabilidade da TV diante das novas concepções teológicas das ADs ao longo dos anos, investimento em canal aberto (Rede Boas Novas de Televisão) e proposta de um programa televisivo como marca midiática da denominação (Programa Movimento Pentecostal). Para viabilidade desse trabalho, a metodologia adotada consiste em pesquisa bibliográfica histórica, com foco nos temas fundamentais para o desenvolvimento das pesquisas do imaginário, identidade, cultura, nação e televisão, aliada à pesquisa documental, que tem como meta os registros históricos, que melhor elucidarão os caminhos e a ligação da TV com as Assembleias de Deus.

Toward A Reliable Quality Control Test For Microneedle Insertion

Microneedles (MNs) are emerging devices that can be used for the delivery of drugs at specific locations1. Their performance is primarily judged by different features and the penetration through tissue is one of the most important aspects to evaluate. For detailed studies of MN performance different kind of in-vitro, exvivo and in-vivo tests should be performed. The main limitation of some of these tests is that biological tissue is too heterogeneous, unstable and difficult to obtain. In addition the use of biological materials sometimes present legal issues. There are many studies dealing with artificial membranes for drug diffusion2, but studies of artificial membranes for Microneedle mechanical characterization are scarce3. In order to overcome these limitations we have developed tests using synthetic polymeric membranes instead of biological tissue. The selected artificial membrane is homogeneous, stable, and readily available. This material is mainly composed of a roughly equal blend of a hydrocarbon wax and a polyolefin and it is commercially available under the brand name Parafilm®. The insertion of different kind of MN arrays prepared from crosslinked polymers were performed using this membrane and correlated with the insertion of the MN arrays in ex-vivo neonatal porcine skin. The insertion depth of the MNs was evaluated using Optical coherence tomography (OCT). The implementation of MN transdermal patches in the market can be improved by make this product user-friendly and easy to use. Therefore, manual insertion is preferred to other kind of procedures. Consequently, the insertion studies were performed in neonatal porcine skin and the artificial membrane using a manual insertion force applied by human volunteers. The insertion studies using manual forces correlated very well with the same studies performed with a Texture Analyzer equipment. These synthetic membranes seem to mimic closely the mechanical properties of the skin for the insertion of MNs using different methods of insertion. In conclusion, this artificial membrane substrate offers a valid alternative to biological tissue for the testing of MN insertion and can be a good candidate for developing a reliable quality control MN insertion test.

Essays on competition in the pharmaceutical industry

Chapter 1: Patents and Entry Competition in the Pharmaceutical Industry: The Role of Marketing Exclusivity. Effective patent length for innovation drugs is severely curtailed because of extensive efficacy and safety tests required for FDA approval, raising concern over adequacy of incentives for new drug development. The Hatch-Waxman Act extends patent length for new drugs by five years, but also promotes generic entry by simplifying approval procedures and granting 180-day marketing exclusivity to a first generic entrant before the patent expires. In this paper we present a dynamic model to examine the effect of marketing exclusivity. We find that marketing exclusivity may be redundant and its removal may increase generic firms' profits and social welfare. ^ Chapter 2: Why Authorized Generics?: Theoretical and Empirical Investigations Facing generic competition, the brand-name companies some-times launch generic versions themselves called authorized generics. This practice is puzzling. If it is cannibalization, it cannot be profitable. If it is divisionalization, it should be practiced always instead of sometimes. I explain this phenomenon in terms of switching costs in a model in which the incumbent first develops a customer base to ready itself against generic competition later. I show that only sufficiently low switching costs or large market size justifies launch of AGs. I then use prescription drug data to test those results and find support. ^ Chapter 3: The Merger Paradox and R&D Oligopoly theory says that merger is unprofitable, unless a majority of firms in industry merge. Here, we introduce R&D opportunities to resolve this so-called merger paradox. We have three results. First, when there is one R&D firm, that firm can profitably merge with any number of non-R&D firms. Second, with multiple R&D firms and multiple non-R&D firms, all R&D firms can profitably merge. Third, with two R&D firms and two non-R&D firms, each R&D firms prefer to merge with a non-R&D firm. With three or more than non-R&D firms, however, the R&D firms prefer to merge with each other.^

Email advertising : exploratory insights from Finland

Since the advent of the internet, much speculation has ensued regarding its tangible benefits to business. This article looks at the effectiveness of email advertising to promote information to consumers. Within this email promotion context, and using data from a survey of 838 female Finnish consumers of a major international cosmetics brand, we investigate consumer perceptions of email advertising. Specifically, within an exploratory research context we address two research questions: (1) What email advertising factors may influence visits to the company website? and (2) What email advertising factors may influence visits to a physical (i.e., bricks-and-mortar) company sales outlet? Results suggest that email advertisers should strive to generate emails that are perceived as useful. Useful emails appear to influence consumers to visit the store primarily to either buy the product or view the product firsthand, rather than visit the company website. However, as consumers could not buy the advertised products from the website, these findings should be regarded as preliminary. Factors influencing perceptions of email advertising usefulness are explored along with limitations and future research directions.

An application of Keller’s Brand Equity Model in a B2B context

Powerful brands create meaningful images in the minds of customers (Keller, 1993). A strong brand image and reputation enhances differentiation and has a positive influence on buying behaviour (Gordon et al., 1993; McEnally and de Chernatony, 1999). While the power of branding is widely acknowledged in consumer markets, the nature and importance of branding in industrial markets remains under-researched. Many business-to-business (B2B) strategists have claimed brand-building belongs in the consumer realm. They argue that industrial products do not need branding as it is confusing and adds little value to functional products (Collins, 1977; Lorge, 1998; Saunders and Watt, 1979). Others argue that branding and the concept of brand equity however are increasingly important in industrial markets, because it has been shown that what a brand means to a buyer can be a determining factor in deciding between industrial purchase alternatives (Aaker, 1991). In this context, it is critical for suppliers to initiate and sustain relationships due to the small number of potential customers (Ambler, 1995; Webster and Keller, 2004). To date however, there is no model available to assist B2B marketers in identifying and measuring brand equity. In this paper, we take a step in that direction by operationalising and empirically testing a prominent brand equity model in a B2B context. This makes not only a theoretical contribution by advancing branding research, but also addresses a managerial need for information that will assist in the assessment of industrial branding efforts.

Conceptualizing and measuring brand relationship quality

Many consumer markets are now characterized by a high degree of market saturation and an increasing level of competition, in particular from retailer brands. Furthermore, consumers face an ever increasing level of product variety. For instance, about 30,000 new products in the fast moving consumer goods (FMCG) market have been launched in Germany in a single year representing about 600 products per week. The increasing number of consumer brands thus has led to a form of “brand inflation” in FMCG markets. In addition, the role of consumers in the marketplace has changed as well. Consumers are more price sensitive, they have higher expectations with regard to product quality and customer service, and they rely rather on word-of-mouth communication than on traditional advertising. In addition, it appears that consumers have become more critical with regard to the perception of brands. High levels of price competition have led to a decreasing level of brand awareness and increased switching intentions of brands. As a consequence, the role of customer loyalty has become an increasingly important topic for businesses in consumer markets.

Loyalty (Brand Loyalty)

Loyalty is a desired marketing outcome for products ranging from fast-moving consumer goods, services, durables, and ideas products such as political parties and social behaviors. Evidence has shown that a base of loyal customers is advantageous for an organization as it reduces the marketing cost of doing business and improves profitability. The approaches to loyalty have varied over the decades with various schools of thoughts toward definitions, conceptualizations, and measurement. The need for understanding the nature of the product and consumer's behavior to determine the appropriate approach to loyalty is emphasized in this article. In this article, we outline the historical development of brand loyalty, the major approaches to the construct (attitudinal and behavioral) and new approaches that deconstruct attitudinal loyalty into its subcomponent parts.

Increasing attractiveness of high-end products

An important decision brand managers have to make when positioning their products in a retail setting is to whether price new line extensions at parity or let products vary in the price/quality spectrum. Despite the growing interest in vertical line extension issues, there has been little research investigating how product-line length affects extension favorability. Therefore, this paper investigates the framing effect that a product line price structure has on consumer judgments of vertical extensions and, in particular, of upscale extensions. A basic proposition of this research is that the parent brand price range affects the perceived or psychological distance between extension and parent brand, influencing extension favorability ratings. In two experiments, it is shown that positioning an upscale extension in the context of a wide product-line will lead to higher consistency perceptions between the parent brand and a new upscale extension than an equivalent upscale extension positioned in the context of a narrow parent brand product-line.