Evaluation of Suspected Counterfeit Pharmaceutical Tablets Declared to Contain Controlled Substances Using Handheld Raman Spectrometers

This study describes the performance of handheld Raman devices for determining whether suspect pharmaceutical tablets declared to contain controlled substances were consistent with authentic (CWA) or not consistent with authentic (NCWA) tablets using a simple, rapid, field-friendly method capable of being used by nonexperts. Twenty-five authentic products and 84 known NCWA tablets were examined using three “parent” devices for a total of 327 analyses. On average, the parent devices yielded a true pass rate of 100%, a true fail rate of 98.4%, a false pass rate of 1.6%, and a false fail rate of 0%. The methods/libraries were then transferred to 13 identical “daughter” devices, which were used to examine 10 suspect finished dosage forms in duplicate (six known NCWA tablets and four authentic tablets) for a total of 260 measurements. On average, the daughter devices had a true pass rate of 100%, a true fail rate of 95.5%, a false pass rate of 4.5%, and a false fail rate of 0.0%. These data demonstrate that the parent–daughter electronic transfer method was successful, which permits the ability to develop methods in the laboratory that can be seamlessly pushed out to field devices. The methods can then be used to (i) prioritize samples for additional testing using other more time-consuming laboratory-based techniques needed to detect and quantify active ingredients and (ii) help support the interdiction of dangerous tablets at ports of entry, thereby preventing them from reaching the supply chain.     

Detection of Mitragynine in Mitragyna Speciosa (Kratom) Using Surface-Enhanced Raman Spectroscopy with Handheld Devices

A simple, quick, selective, sensitive, and effective field-friendly method capable of being used by nonexperts has been developed for detecting mitragynine in Mitragyna speciosa (kratom) using surface-enhanced Raman spectroscopy (SERS). Over 100 samples and blanks (known to be either positive or negative for the presence of mitragynine) were examined in duplicate using five identical handheld Raman spectrometers, which provided a data set of over 1,000 examinations. Based on the results of these analyses, the method yielded a true-positive rate of 99.3%, a true-negative rate of 97.9%, a false-positive rate of 2.1%, and a false-negative rate of 0.7%. The average minimum detectable concentration (C_m) of mitragynine that reproducibly yielded a match for one of the library spectra on all five instruments was determined to be 342 ng/mL (ppb). This C_m value is a conservative estimate considering that the extraction process was not fully optimized by this study, which was not necessary since the C_m value achieved was well below typical mitragynine concentrations in kratom (1.3–2.3%). The method is ideal (i) for prioritizing samples for additional testing using other more time-consuming laboratory-based techniques needed to detect and quantify mitragynine and (ii) for field use at international mail facility (IMF) satellite laboratories to help interdict kratom and prevent this dangerous product from reaching the U.S. supply chain.     

The promises and pitfalls of polysemic ideas: ‘One Health’ and antimicrobial resistance policy in Australia and the UK

Policy Sciences - Recent scholarship posits that ambiguous (‘polysemic’) ideas are effective for coalition building between diverse stakeholders: their capacity to be interpreted...     

Why Are There So Many Lawyers in Congress?

Scholars have long sought to explain the overrepresentation of lawyers in Congress. This article draws on a wealth of data to explore the causes and consequences of this representational imbalance. While lawyers enter politics at higher rates, self-selection at best provides a partial explanation. Conditional on running, lawyers win at twice the rate of candidates from other backgrounds. Contrary to prevailing theories in the literature, voters do not reward candidates with backgrounds in law. Rather, lawyers win because of a sizable competitive advantage in early fundraising, owing in large part to their professional networks. This study has important implications for who runs for office, who wins, and the demographic composition of Congress. It also identifies an underexplored mechanism by which the US system of campaign finance sustains deep representational imbalances.     

Four Lessons for Developing Countries from the Trade Negotiations Over Access to Medicines

After the Agreement on the Trade-Related Aspects of Intellectual Property Rights (TRIPS) came into operation in 1995 developing countries have found themselves in a process of continual negotiation over intellectual property rights and access to medicines. These negotiations have taken place in the World Trade Organization and in the context of free trade agreements. The paper suggests that the only real win for developing countries has been the Doha Declaration on the TRIPS Agreement and Public Health in 2001. What have been the lessons for developing countries in a decade of negotiations over access to medicines? Drawing on themes of rule complexity and regulatory ritualism the paper discusses four key lessons for developing countries. It concludes by arguing that developing countries will do better if they adopt a networked governance approach to negotiation rather than continuing to rely on traditional coalition formation.     

“The Spectacle of Fearsome Acts”: Crime in the Melting P(l)ot in <Emphasis Type="Italic">Gangs of New York</Emphasis>

This paper explores the multi-layered representations of violence and crime in the recent Hollywood film Gangs of New York [Scorcese (2003) Miramax]. We use our exploration of this film to suggest that popular culture, even through its most mainstream products, can be seen as a critical criminological space where alternative views of law, crime and the state are made available. Rather than understanding Hollywood movies simply as vehicles for disseminating conventional mores, we suggest that they can furnish critical (and complex) points of view on law and crime and that the project of a critical criminology can be strengthened by engaging more forthrightly with these ubiquitous cultural forms.     

The challenge of institution-building in Asia and its implications for Asia-Europe relations

  East Asia, including Northeast Asia and Southeast Asia, has developed tightly-linked production/distribution networks through globalizing corporate activities. The vertical chain of production in East Asia has been even more sophisticated than economic integration in East Europe or Latin America. However, the political environment of East Asia for trade and investment has been far from borderless. The integration effort at the policy level has been very much limited so far, due to the historical background as well as geopolitics surrounding East Asia. The Asian currency/financial crisis provided these countries a historical turning point. After the burst of the crisis, East Asians realized that they have to take care of themselves in their difficulties, not depending on outside forces. A natural choice for them was to step into the realm of regionalism. In 1998, Japan and Korea officially announced that they would discard the long-lasting GATT/WTO-only approach and adapt the multi-layered approach, including both regionalism and multilateralism. The ultimate goal of regionalism would be a region-wide integration including ASEAN+3. As a steppingstone, Japan signed the Japan-Singapore Economic Partnership Agreement (JSEPA) in January 2002. In a parallel move, the ASEAN and China Leaders announced in November 2001 the establishment of an ASEAN-China Free Trade Area (ACFTA) within 10 years. This article will follow up the most recent advancement of regional institutional building in East Asia with the emphasis on peculiar characteristics of economic integration in the region and discuss its implications for Asia-Europe relations. This paper is heavily drawn from Kimura (2002, 2003).     

S&;T Parks and business incubators in middle-sized countries: the case of greece

This paper links the policy context regarding S&T parks to the objectives and characteristics of the established parks and incubators in a relatively small, converging European country. S&T parks and incubators in Greece during the past decade and a half have gradually shifted in terms of ownership and management from university/research institute to the private sector and in terms of financing from public to private funds, also involving the provision of seed capital and access to venture capital. This gradual shift toward more private engagement has created a variety of models out of which, it is hoped, successful innovative companies will emerge in larger numbers than in the past.

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