This article evaluates the oversight of drugs and medical devices by the U.S. Food and Drug Administration using an integration of public policy, law, and bioethics approaches and employing multiple assessment criteria, including economic, social, safety, and technological. Criteria assessment and expert elicitation are combined with existing literature, case law, and regulations in an integrative historical case studies approach. We then use our findings as a tool to explore possibilities for effective oversight and regulatory mechanisms for nanobiotechnology. Section I describes (...) oversight mechanisms for human drugs and medical devices and presents current nanotechnology products. Section II describes the results of expert elicitation research. Section III highlights key criteria and relates them to the literature and larger debate. We conclude with broad lessons for the oversight of nanobiotechnology informed by Sections I-III in order to provide useful analysis from multiple disciplines and perspectives to guide discussions regarding appropriate FDA oversight. (shrink)

This article evaluates the oversight of drugs and medical devices by the U.S. Food and Drug Administration using an integration of public policy, law, and bioethics approaches and employing multiple assessment criteria, including economic, social, safety, and technological. Throughout, assessments employing both the multiple criteria and a method of expert elicitation are combined with the existing literature, case law, and regulations providing an integrative historical case study approach. The goal is to provide useful information from multiple disciplines and perspectives to (...) guide discussions regarding appropriate oversight frameworks for nanobiotechnology applications under the FDA’s purview. (shrink)

Nanomedicine is yielding new and improved treatments and diagnostics for a range of diseases and disorders. Nanomedicine applications incorporate materials and components with nanoscale dimensions where novel physiochemical properties emerge as a result of size-dependent phenomena and high surface-to-mass ratio. Nanotherapeutics and in vivo nanodiagnostics are a subset of nanomedicine products that enter the human body. These include drugs, biological products, implantable medical devices, and combination products that are designed to function in the body in ways unachievable at larger scales. (...) Nanotherapeutics andin vivonanodiagnostics incorporate materials that are engineered at the nanoscale to express novel properties that are medicinally useful. These nanomedicine applications can also contain nanomaterials that are biologically active, producing interactions that depend on biological triggers. Examples include nanoscale formulations of insoluble drugs to improve bioavailability and pharmacokinetics, drugs encapsulated in hollow nanoparticles with the ability to target and cross cellular and tissue membranes and to release their payload at a specific time or location, imaging agents that demonstrate novel optical properties to aid in locating micrometastases, and antimicrobial and drug-eluting components or coatings of implantable medical devices such as stents. (shrink)

Several authors have hypothesized that completely positive maps should provide the means for generalizing quantum dynamics. In a critical analysis of that proposal, we show that such maps are incompatible with the standard phenomenological theory of spin relaxation and that the theoretical argument which has been offered as justification for the hypothesis is fallacious.

This paper explores the possibility that linear dynamical maps might be used to describe the energy-conserving, entropy-increasing motions which occur in closed thermodynamic systems as they approach canonical thermal equilibrium. ForN-level quantum systems withN>2, we prove that no such maps exist which are independent of the initial state.

In this rejoinder to a critique by Raggio and Primas of our paper, “On Completely Positive Maps in Generalized Quantum Dynamics,” we acknowledge that, contrary to our original assertion, the Bloch equations are indeed completely positive. We then explain briefly why this modification of our analysis does not alter its main conclusions.

Academic freedom and tenure, both cherished institutions of higher education, are currently under attack by many both outside and within the academy. Richard DeGeorge argues that they can be defended on ethical grounds only if they are joined with appropriate accountability, publicly articulated and defended standards, and conscientious enforcement of these standards by academic institutions and the members of the academic community.

We give a general method for constructing lattices L whose equational theories are inherently nonfinitely based. This means that the equational class generated by L is locally finite and that L belongs to no locally finite finitely axiomatizable equational class. We also provide an example of a lattice which fails to be inherently nonfinitely based but whose equational theory is not finitely axiomatizable.

In two recent studies we have examined the prose rhythms in the clausulae of late imperial Latin authors. We found two clausular systems to be prevalent, the cursus and the cursus mixtus. The cursus involves the use of accentual rhythms and consists of three basic cadences: planus, tardus, and velox. The cursus mixtus has been defined by modern scholars as a type of prose rhythm in which the clausula is structured along both accentual and metrical lines, that is by the (...) combination of one of the three forms of the cursus with one of the standard metrical forms derived from Cicero's system — cretic-spondee, dicretic, cretic-tribrach, or ditrochee. (shrink)

The United Nations (UN) Universal Declaration of Human Rights engenders important state commitments to respect, fulfill, and protect a broad range of socio-economic rights. In 2010, a milestone was reached when the UN General Assembly recognized the human right to safe and clean drinking water and sanitation. However, water plays an important role in realizing other human rights such as the right to food and livelihoods, and in realizing the Convention on the Elimination of All Forms of Discrimination against Women. (...) These broader water-related rights have been recognized but have not yet been operationalized. This paper unravels these broader water-related rights in a more holistic interpretation of existing international human rights law. By focusing on an emerging approach to water services provision—known as ‘domestic-plus’ services—the paper argues how this approach operationalizes a comprehensive range of socio-economic rights in rural and peri-urban areas. Domestic-plus services provide water for domestic and productive uses around homesteads, which challenges the widespread practice in the public sector of planning and designing water infrastructure for a single-use. Evidence is presented to show that people in rural communities are already using their water supplies planned for domestic uses to support a wide range of productive activities. Domestic-plus services recognize and plan for these multiple-uses, while respecting the priority for clean and safe drinking water. The paper concludes that domestic-plus services operationalize the obligation to progressively fulfill a comprehensive range of indivisible socio-economic rights in rural and peri-urban areas. (shrink)

In this paper, we discuss the macroscopic quantum behavior of simple superconducting circuits. Starting from a Lagrangian for electromagnetic field with broken gauge symmetry, we construct a quantum circuit model for a superconducting weak link (SQUID) ring, together with the appropriate canonical commutation relations. We demonstrate that this model can be used to describe macroscopic excitations of the superconducting condensate and the localized charge states found in some ultrasmall-capacitance weak-link devices.

The statistical properties of a single quantum object and an ensemble of independent such objects are considered in detail for two-level systems. Computer simulations of dynamic zero-point quantum fluctuations for a single quantum object are reported and compared with analytic solutions for the ensemble case.

Nanotechnology, as with many technologies before it, places a strain on existing legislation and poses a challenge to all administrative agencies tasked with regulating technology-based products. It is easy to see how statutory schemes become outdated, as our ability to understand and affect the world progresses. In this article, we address the regulatory problems that nanotechnology posses for the Food and Drug Administration’s (FDA) classification structure for ‘‘drugs’’ and ‘‘devices.’’ The last major modification to these terms was in 1976, with (...) the enactment of the Medical Device Amendments. There are serious practical differences for a classification as a drug or device in terms of time to market and research. Drugs are classified, primarily, as acting by ‘‘chemical action.’’ We lay out some legal, philosophic, and scientific tools that serve to provide a useful, as well as legally and scientifically faithful, distinction between drugs and devices for the purpose of regulatory classification. These issues we raise are worth the consideration of anyone who is interested in the regulation of nano-products or other novel technologies. (shrink)

In several recent studies we have developed precise statistical methodologies which have demonstrated that the cursus mixtus was the dominant rhythmical system for final clausulae in Latin prose from the third century a.d. to the fifth. The cursus mixtus consisted of four standard metrical forms derived from the richer variety of Cicero's Asiatic tradition – cretic-spondee, dicretic, cretic-tribrach and ditrochee –, which were structured according to three accentual patterns – planus, tardus and velox. The latter are differentiated by the number (...) of unstressed syllables intervening between and following two accented syllables. The planus has two unaccented syllables between two word accents and one after the last accent. The tardus has two between two accents and two after the last accent. The velox has four between two accents and one after the last accent. The four metrical forms are contained within the parameters of the accentual cadences. The planus contains either the cretic-spondee or the ditrochee ; the tardus either the dicretic or the cretic-tribrach ; the velox either the ditrochee or the cretic-spondee (nimium videbatur. Authors who used the cursus mixtus, however, preferred to effect an exact coincidence between the accent and ictus, and as a result evinced primarily the following standard rhythmical forms: planus/cretic-spondee; tardus/dicretic or cretic-tribrach; and velox/ditrochee. So far now we have examined only the rhythmical properties of final clausulae, but it is appropriate also to investigate for rhythm at internal positions within the sentence. (shrink)

This study probed a crucial assumption underlying much of the ethics theory and research: do managers perceive ethical behavior to be an important personal job requirement? A large sample of managers from a cross-section of industries and job functions indicated that, compared to other job duties, certain ethical behaviors were moderate to somewhat major parts of their jobs. Some noteworthy differences by industry, organization size, tenure and job function were also found. These findings underscore the importance of ethics for business (...) education. They also have implications for manager selection, training, and development by organizations. (shrink)

This book presents the foundations of a general theory of algebras. Often called “universal algebra”, this theory provides a common framework for all algebraic systems, including groups, rings, modules, fields, and lattices. Each chapter is replete with useful illustrations and exercises that solidify the reader's understanding. The book begins by developing the main concepts and working tools of algebras and lattices, and continues with examples of classical algebraic systems like groups, semigroups, monoids, and categories. The essence of the book lies (...) in Chapter 4, which provides not only basic concepts and results of general algebra, but also the perspectives and intuitions shared by practitioners of the field. The book finishes with a study of possible uniqueness of factorizations of an algebra into a direct product of directly indecomposable algebras. There is enough material in this text for a two semester course sequence, but a one semester course could also focus primarily on Chapter 4, with additional topics selected from throughout the text. (shrink)

We are currently seeing a revival of interest in Aquinas's moral thought among Christian ethicists, both Protestant and Catholic. Although recent studies of his moral thought have touched on a number of topics, the majority of these have focused on his account of the virtues and their place in the Christian life. Probing the questions of the relation of virtue and law, the role of reason and will, and the place of the passions in Aquinas's moral theology, I will examine (...) recent studies by Diana Cates, Pamela Hall, Simon Harak, James Keenan, Daniel Nelson, Daniel Westberg, and Paul Waddell. In different ways these studies return us repeatedly to the vexed and unresolved question of the scope of human freedom. (shrink)

At the request of the Classical Journals Board we have undertaken for the present to edit this Journal. In so doing we confidently rely upon the co-operation of those who have hitherto been contributors, as well as of others who may be in a position to assist us.

Antibodies that are specific for DNA provide an excellent system for studying the protein‐nucleic acid interactions that allow proteins to recognize specific DNA structures or sequences.

Delivering high quality genomics-informed care to patients requires accurate test results whose clinical implications are understood. While other actors, including state agencies, professional organizations, and clinicians, are involved, this article focuses on the extent to which the federal agencies that play the most prominent roles — the Centers for Medicare and Medicaid Services enforcing CLIA and the FDA — effectively ensure that these elements are met and concludes by suggesting possible ways to improve their oversight of genomic testing.

MS. 124 in the library of St. John Baptist College, Oxford, is a quarto of 154 pages, written in two or more hands of the fifteenth century. Its provenance is unknown, and, as it has been carefully and ruthlessly rebound at some time in the nineteenth century, it is impossible to derive any information from the binding. After an unusually elabbrate alphabetical index it bears on folio 11 an inscription in a seventeenth-century hand as follows: ‘Libellus Thomae de Walsingham De (...) generacione naturaque deorum simul cum interpretatione Ouidii Metamorphoseon Simoni Priori Sancti Albani dedicatus.’. (shrink)