bluuebunny/crossref_metadata_2025_split huggingface dataset:
Innovation – Patents, Generics and Payers: The Political Dynamics of Interaction
Authors: Redwood Heinz 
Published: February 2007

This paper sets out to explore the relationship between pharmaceutical innovation, its industrial dependence on patent protection, the advent of cheaper generics after patent expiry and the cumulative impact of these issues and events on healthcare payers. Three observations will help to set the scene. These relationships are not static, but dynamic. They change over time as the pendulum tends to swing. The issues under observation are heavily politicised because the conduct, financing and outcome of healthcare are all politically controversial and influential in general elections. Pharmaceuticals are both an industry and a component of healthcare. The political balance, at government level, between healthcare policy and industrial policy for pharmaceuticals will profoundly affect the prospects of both the research-based and the generics sector of the industry. Historically, the two sectors became clearly distinguishable in the 1930s.
The EU Regulatory Environment for ‘Biosimilars’: Today's Picture and Future Prospects
Authors: Rossignol Nicolas 
Published: February 2007

Times are changing in biotechnology. With the expiration of patent protection for some of the most profitable biologics in the next few years, a new, fast-growing field has started to emerge: ‘biogenerics’. Known as ‘similar biological medicinal products’ or ‘biosimilars’ in Europe, these products are about to enter the now-enlarged Community market. A number of uncertainties and challenges still lie ahead, though. To regulate biosimilars means dealing with complex molecules, which are tricky to characterise and highly sensitive to manufacturing changes, to which a ‘classical’ generics approach is not directly applicable. Specific legislation needs to be put in place. While hearings regarding the need for special regulation on ‘biogenerics’ are now being held in the USA, European regulatory authorities have taken the lead by establishing a tailor-made legal framework for biosimilars with the publication of the so-called ‘Annex I’, in 2003. Further developments are expected with the revision of the EU pharmaceutical legislation (the Pharma Review), which was adopted by European institutions in 2004. The purpose of this article is to provide an overview of this framework, the main consequences of the Pharma Review and a discussion on key points to be considered when entering this emerging market.
Battle for the Market: Branded Drug Companies' Secret Weapons Generic Drug Makers Must Know
Authors: Hess Jon , Litalien Shannon 
Published: February 2007

Generic drugs now account for more than $40bn in prescription sales worldwide. More than $80bn worth of global blockbuster drugs face US patent expiration by 2008. The battle for market share between the booming generics drug industry and the at-risk branded drug industry is raging. As patent expiry looms, branded drugs can no longer only focus on extending product lives. They need defensive strategies to combat their generics competitors actively and retain market share. To maintain rapid growth, generic drugs makers not only need to understand the nature of these defensive strategies, but they must also be prepared to deal with them as they bring their products to market. The most important and commonly-implemented strategies are discussed in this paper and the authors suggest that branded and generic drugs companies can successfully apply or manoeuvre against these strategies to distinguish themselves within an industry where lines are blurring and competition is increasing.
Safeguarding Access to Medicines in Developing Countries: Strategies and Principles
Authors: Timmermans Karin 
Published: February 2007

The Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS) has harmonised standards for intellectual property rights, including patents. For developing countries, these new standards are usually higher than their previous standards. As a result, it will take longer for generic versions of new drugs to enter their markets. This risks compromising access to medicines. This paper points out that developing countries can mitigate the negative impact on access by ensuring that domestic laws contain workable provisions for compulsory licensing and other TRIPS-compliant safeguard mechanisms and by gaining experience in using them. But countries should also avoid issuing trivial patents, for instance by applying strict criteria for patentability. This will, however, require a change in attitude towards and administration of intellectual property rights. Generics companies should nurture and actively support a more critical attitude to pharmaceutical patents.
Ongoing Monitoring of Antiretroviral Products as Part of WHO's Prequalification Project
Authors: Dekker Theo G. , van Zyl Adriaan J. , Gross Olivier , Taševská Ivana , Stahl Matthias M. S. , Rabouhans Marie L. , Rägo Lembit 
Published: February 2007

The supply of quality medicines used in the treatment of HIV/AIDS has become a major concern at both international and country level. The Prequalification Project, set up in 2001, is a service provided by the World Health Organization (WHO) to facilitate access to medicines that meet unified standards of quality, safety and efficacy for HIV/AIDS, malaria and tuberculosis. The main purpose of the project with respect to HIV/AIDS is to assess the quality, safety and efficacy of medicines (both antiretrovirals [ARVs] and medicines for HIV/AIDS care) in accordance with international standards and to ensure that good manufacturing practice is applied at the manufacturing sites. The assessment further includes reviewing bioequivalence data and inspecting respective contract research organisations where the clinical trials were conducted for compliance with good clinical practice. Only products meeting all the requirements are listed on the prequalified products list. As part of the quality assurance element of the Prequalification Project, samples of 33 HIV/AIDS products, of which 24 were ARVs and 9 were for HIV/AIDS care, submitted for prequalification were subjected to quality control (QC) testing in 2002. This was followed by a second round of QC testing during 2004 on 11 ARV products, including comparison of dissolution profiles of generic products against the relevant innovator products. Some of the products tested appear on the current Prequalification list. All samples but one met the shelf-life specifications for content and, where tested, for identification of the active pharmaceutical ingredient, dissolution, average mass and uniformity of mass. One product sample did not meet the content specifications; however, the number of tablets required for assay testing and consequently also for confirmative retesting was insufficient, and therefore the result cannot be considered conclusive. Another product did not meet the requirements for similarity of dissolution profile against the innovator product, though it proved to be rapidly dissolving.
Creating eCTD Applications
Authors: Nordfjeld Kim , Strasberger Vito 
Published: February 2007

The electronic Common Technical Document (eCTD) is defined as an interface for industry to agency transfer of regulatory information, while at the same time taking into consideration the facilitation of the creation, review, lifecycle management and archival of the electronic submission. eCTD is just an ‘envelope’ that will enable industry to communicate and exchange information easily and should be considered only as the final step in the process of generating an electronic submission. The authors firmly believe that optimal eCTD is based on a solid integrated document management system. Submission management in the generics industry is a process and the document management system should therefore be adapted to support this process of dossier creation and post-application management of hundreds, or even thousands, of dossiers. In order to effectively implement this process, it is highly recommended that a document management system is configured in such away that every individual document is stored in the system only once. The most effective integration of a document management system and publishing system will enable production of a CTD or eCTD from the same initial documents. This will enable companies to support the submission process in cases where only paper submission is needed, only electronic, or both.
Economics and Preventing Hospital-Acquired Infection: Broadening the Perspective
Authors: Graves Nicholas , Halton Kate , Lairson David 
Published: February 2007

Objective.To present a hypothetical model of the change in economic costs and health benefits to society that result from nosocomial infection control programs.Design.We use a modeling framework to represent how 2 types of costs change with nosocomial infection control programs: costs incurred by the hospital sector and community health services, as well as the private costs to patients. We also demonstrate how to value the health benefits of nosocomial infection control programs, using quality-adjusted life years.Setting.Hypothetical modeling to incorporate the societal perspective.Subjects.A cohort of 50,000 simulated patients at risk of surgical site infection following total hip replacement.Intervention(s).A total of 8 hypothetical interventions that change costs and health outcomes among the cohort by preventing cases of surgical site infection following total hip replacement.Results and Conclusions.We demonstrate that when infection control interventions reduce economic costs and increase health benefits, they should be adopted without further question. If, however, interventions increase economic costs and increase health benefits, then the trade—off between costs and benefits should be examined. Decision-makers should assess the cost per unit of health benefit from infection control programs, consider the impact on health budgets, and compare infection control with alternative uses of scarce healthcare resources.
Recommendations for Surveillance of Clostridium difficile–Associated Disease
Authors: McDonald L. Clifford , Coignard Bruno , Dubberke Erik , Song Xiaoyan , Horan Teresa , Kutty Preeta K. ,   the Ad Hoc Clostridium difficile Surveillance Working Group
Published: February 2007

Background.The epidemiology of Clostridium difficile-associated disease (CDAD) is changing, with evidence of increased incidence and severity. However, the understanding of the magnitude of and reasons for this change is currently hampered by the lack of standardized surveillance methods.Objective and Methods.An ad hoc C. difficile surveillance working group was formed to develop interim surveillance definitions and recommendations based on existing literature and expert opinion that can help to improve CDAD surveillance and prevention efforts.Definitions and Recommendations.A CDAD case patient was defined as a patient with symptoms of diarrhea or toxic megacolon combined with a positive result of a laboratory assay and/or endoscopic or histopathologic evidence of pseudomembranous colitis. Recurrent CDAD was defined as repeated episodes within 8 weeks of each other. Severe CDAD was defined by CDAD-associated admission to an intensive care unit, colectomy, or death within 30 days after onset. Case patients were categorized by the setting in which C. difficile was likely acquired, to account for recent evidence that suggests that healthcare facility-associated CDAD may have its onset in the community up to 4 weeks after discharge. Tracking of healthcare facility–onset, healthcare facility–associated CDAD is the minimum surveillance required for healthcare settings; tracking of community–onset, healthcare facility–associated CDAD should be performed only in conjunction with tracking of healthcare facility–onset, healthcare facility–associated CDAD. Community–associated CDAD was defined by symptom onset more than 12 weeks after the last discharge from a healthcare facility. Rates of both healthcare facility–onset, healthcare facility–associated CDAD and community–onset, healthcare facility–associated CDAD should be expressed as case patients per 10,000 patient–days; rates of community-associated CDAD should be expressed as case patients per 100,000 person-years.
The Incarnation of the Word
Authors: Cullen Christopher M. 
Published: February 2007

Abstract
Bonaventure holds that God does all things with power, wisdom, and goodness; such as in the case of the restoration. If Incarnation is examined as a work of God in the light of power, wisdom, and goodness, we can see why it is the most perfect of all God's works, for there cannot be any greater act of power than to combine within a single person two natures: the human and divine. While Bonaventure stresses the gratuity of the redemption — that is, God was in no way obliged to save us — he is very clear that man could not have been saved by any healer other than God.
Diaspora of the Gods
Authors: Waghorne Joanne Punzo 
Published: February 2007

Abstract
From Chennai (Madras), India to London and Washington D.C., contemporary urban middle-class Hindus invest earnings, often derived from the global economy, into the construction or renovation of temples. South Indians often lead such efforts to re-establish authentic temples that nonetheless become sites for innovative communities, new visions of the Gods, and distinctive middle-class religious sensibilities. Although a part of the much-discussed resurgence of Hinduism, Gods and their ritual worship — not nationalistic ideology — center these enterprises. This book aims to go beyond the more common analytical starting points of identity, multiculturalism, transnationalism, or globalism to understand contemporary Hinduism. In both conversation and contention with current theory, the book highlights the Gods, their shrines, and the middle-class people who re-establish them. Using surveys of modern temples in Chennai, London, and Washington D.C. patronized by South Indians, it focuses on the ubiquity of certain Gods and Goddesses — but not all — their portrayal, the architecture of their new “homes”, and their place in the modern urban commercial and social landscapes. Arguing that this migration of Gods in tandem with people is not new, the book traces current temple architecture to Indian merchants who constructed new temples within a decade of the founding of Madras by the East India Trading Company in the initial era of the current world economic system. In the process, it questions the interrelationships between ritual worship/religious edifices, the rise of the modern world economy, and the ascendancy of the great middle class in this new era of globalization.
Mylapore
Authors: Waghorne Joanne Punzo 
Published: February 2007

Abstract
Colonial Madras surrounded and transformed ancient Mylapore into an inner-city neighborhood. This chapter traces the complexities of the modern reconstruction of “Tradition” through the Kapaleeswara Temple at Mylapore's center. Rare maps from the 1800s show that a new class of landholder-businessmen (Mudaliars), acting as Company middlemen (Dubash), rebuilt the current temple in the mid 1700s on the model of revered poetic descriptions of its ancient namesake but with its Lord, Shiva, now mirroring rising bourgeois values. Later, with the emergence of the Brahman-dominated bureaucracy and the equally Brahman-centered recreation of classical Sanskritic “Hinduism”, the prestige of temples declined. Soon Brahmans dominated Mylapore, which Milton Singer designated in the 1970s as the epicenter of the “Great Tradition”. Today, ritual life at the Kapaleeswara Temple thrives while neighborhood groups renovate surrounding temples, recreate rituals, and in the process rebuild a common middle-class religiosity, which encompasses but also subverts the Great Tradition with rural modalities.
Action, Belief, and Desire
Authors: Audi Robert 
Published: February 2007

Abstract
The parallels between the theoretical and the practical reason are extensive. This chapter considers the structural ones, such as the analogy between, on the one hand, inferential beliefs and the beliefs they are based on and, on the other hand, instrumental desires (desires for things as means) and the basic desires to which they are subordinate. Beliefs of conclusions we infer from certain premises can be justified by our beliefs of those premises. Desires with certain contents can be justified by further desires, above all when the former are desires to take means toward satisfying the latter, “premise” desires. The chapter explains some major substantive parallels between theoretical and practical reason.
Purity, Sacrifice, and the Temple
Authors: Klawans Jonathan 
Published: February 2007

AbstractThis book reevaluates modern scholarly approaches to ancient Jewish cultic rituals, arguing that sacrifice in particular has been long misunderstood. Various religious and cultural ideologies (especially supersessionist ones) have frequently prevented scholars from seeing the Jerusalem temple as a powerful source of meaning and symbolism to those ancient Jews who worshiped there. Such approaches are exposed and countered by reviewing the theoretical literature on sacrifice and taking a fresh look at a broad range of evidence concerning ancient Jewish attitudes toward the temple and its sacrificial cult. Starting with the Hebrew Bible, this work argues for a symbolic understanding of a broad range of cultic practices, including both purity rituals and sacrificial acts. The prophetic literature is also reexamined, with an eye toward clarifying the relationship between the prophets and the sacrificial cult. Later ancient Jewish symbolic understandings of the cult are also revealed in sources including Josephus, Philo, Pseudepigrapha, the Dead Sea Scrolls, New Testament, and Rabbinic literature. A number of ancient Jews certainly did believe that the temple was temporarily tainted or defiled in some fashion, including the Dead Sea sectarians and Jesus. But they continued to speak of the temple in metaphorical terms, and — like practically all ancient Jews — believed in the cult, accepted its symbolic significance, and hoped for its ultimate efficacy.
Sacrifice and Purity
Authors: Klawans Jonathan 
Published: February 2007

AbstractThis chapter reviews theories of sacrifice and interpretations of purity, finding disparities in the ways in which they have been understood by scholarship in recent times. It argues that three biases in particular have unduly affected the analysis of these rituals, with the result that sacrifice has been denied the symbolic understanding more typically applied to purity rites. These biases include Christian and Jewish supersessionism and a contemporary cultural ambivalence toward overt violent rituals. It employs methods inspired by Mary Douglas and argues against approach taken by René Girard.
Temple as Cosmos or Temple in the Cosmos
Authors: Klawans Jonathan 
Published: February 2007

AbstractThis chapter analyzes two distinct symbolic understandings of the Jerusalem temple and its rituals. It finds evidence for a belief in the temple as representing the cosmos in Josephus, Philo and rabbinic literature, and evidence for a belief that the earthly temple represents a heavenly sanctuary in the Pseudepigrapha, Dead Sea Scrolls, and other rabbinic sources. It attempts to identify one or another of these two symbolic understandings as the precursor of the other are rejected.
Sinful People, Impure Priests, and Inadequate Structures
Authors: Klawans Jonathan 
Published: February 2007

AbstractThis chapter examines literature discovered at Qumran and related literature, including the Temple Scroll, with an eye toward describing more fully the anti-temple polemics articulated. It identifies sources making the following claims about the Jerusalem temple: that it is ritually defiled, morally defiled, ritually inadequate, and structurally insufficient. It also reconsiders the sources that ostensibly “spiritualize” the temple, arguing instead that these sources are rooted in beliefs concerning the temple’s importance and efficacy. Sectarian Jews emulated the temple’s rituals and priests in part because they looked forward to the temple being under their own control.
Introduction
Authors: Eisen Robert 
Published: February 2007

Abstract
This introductory chapter begins with a discussion of the fascination with the Book of Job as evidenced by the diverse body of interpretations throughout the ages from religious thinkers in Judaism and Christianity from late antiquity to modern academic scholars. It presents a background of medieval Jewish philosophy, and then reviews the major challenges that interpreters of Job have faced throughout the ages. The present study aims to go beyond providing a description of how medieval Jewish philosophers read the Book of Job by drawing much-needed attention to the exegetical literature in medieval Jewish philosophy in general. By analyzing how medieval Jewish philosophers interpreted the Book of Job, the exegesis of these thinkers is brought to light as an exciting chapter in the history of Jewish thought, which neither scholars of medieval Jewish philosophy nor scholars of medieval Jewish exegesis can afford to ignore. A proper examination of the commentaries chosen and an assessment of their significance both as philosophical and exegetical works require that these be discussed on a number of levels. For each commentary, the discussion will focus on three interfaces: between the commentaries and their antecedent sources, between the commentaries and the biblical text, and between the commentaries and the systematic thought of the medieval Jewish philosophers.
Phenomenal and Perceptual Concepts
Authors: David Papineau 
Published: February 2007

AbstractThis chapter focuses on the topic of phenomenal concepts. It develops and extends the comparison of phenomenal concepts with so-called “perceptual concepts,” to throw the nature of phenomenal concepts into clearer focus. A position against a recent argument by David Chalmers against the whole type-B strategy of defending physicalism by appeal to phenomenal concepts is defended.
Phenomenal Concepts and the Explanatory Gap
Authors: Chalmers David J. 
Published: February 2007

Abstract
Philosophers have reacted in different ways to the apparent explanatory gap between physical processes and consciousness. Some deny that any explanatory gap exists at all. Some hold that there is an explanatory gap for now, but that it will eventually be closed. Some hold that the explanatory gap corresponds to an ontological gap in nature. This chapter explores another reaction to the explanatory gap — those who react in this way agree that there is an explanatory gap, but they hold that it stems from the way we think about consciousness. In particular, this view locates the gap in the relationship between our concepts of physical processes and our concepts of consciousness, rather than in the relationship between physical processes and consciousness themselves.
Natural Justice
Authors: Binmore Ken 
Published: February 2007

Abstract
This book attempts to create an evolutionary theory of fairness. Sharing food is commonplace in the animal kingdom because it insures animals that share against hunger. Anthropologists report that hunter-gatherer societies which survived into the 20th century shared on a very egalitarian basis. What can such information tell us about the sense of fairness with which modern man is born? Using game theory as a basic tool, the book argues that fairness norms should be seen as a device for selecting an efficient equilibrium in the human game of life. Evolutionary arguments are then used to argue that the deep structure of this device resembles the original position formulated by John Rawls in his Theory of Justice. Such an evolutionary framework allows problems over welfare comparison and norm enforcement to be tackled in a manner that resolves the long debate between utilitarianism and egalitarianism.