Preparation of pyrolysis reference samples: evaluation of a standard method using a tube furnace

A new, simple method for the reproducible creation of pyrolysis products from different materials that may be found at a fire scene is described. A temperature programmable steady-state tube furnace was used to generate pyrolysis products from different substrates, including softwoods, paper, vinyl sheet flooring, and carpet. The temperature profile of the tube furnace was characterized, and the suitability of the method to reproducibly create pyrolysates similar to those found in real fire debris was assessed. The use of this method to create proficiency tests to realistically test an examiner's ability to interpret complex gas chromatograph-mass spectrometric fire debris data, and to create a library of pyrolsates generated from materials commonly found at a fire scene, is demonstrated.     

产品责任:北美视角的比较法评论

美国采纳严格产品责任的主要原因是:早期的法律不能给消费者提供充分的保护;调整保证的法律不是从消费者的角度出发的;美国的社会福利很大程度上不如其他西方国家。当今美国主要对于设计和信息性缺陷适用过失责任制度,严格产品制度仅适用于制造缺陷和非制造缺陷的销售者。欧洲和其他法域的严格产品制度远比美国严格。各种结构化和程序化的事务赋予美国公民更多诉至法院的机会。     

Erythrityl tetranitrate; drug efficacy study implementation; revocation of exemption; opportunity for a hearing--FDA. Notice

The Food and Drug Administration (FDA) is revoking the temporary exemption that has allowed single-entity coronary vasodilator drug products containing erythrityl tetranitrate to remain on the market beyond the time limits scheduled for implementation of the Drug Efficacy Study. FDA is announcing that the products lack substantial evidence of effectiveness and is offering an opportunity for a hearing on a proposal to withdraw approval of any applicable new drug applications (NDA's) or abbreviated new drug applications (ANDA's).     

Market definition with differentiated products: a spatial competition application

This paper applies the ‘hypothetical monopolist’ test of market definition to a retail market with products differentiated by means of location and other dimensions. The test for defining the relevant product and geographic market follows the conditions required by the European Union Competition Law and so it takes into account both demand- and supply-side substitution. The empirical model using sales data from a set of movie theatres in the North of Spain, incorporating the observed locations of consumers vis-à-vis the stores, shows that empirical tests of market definition may lead to an implausible (too restrictive) definition of the relevant market if supply-side substitution is not accounted for. It also shows that the main driver of competition in retail markets with differentiated products is not price but product characteristics.     

Development of a specific fragment pattern-based quadrupole-Orbitrap mass spectrometry method to screen adulterated products of phosphodiesterase-5 inhibitors and their analogues

Recently, adulterated supplements with phosphodiesterase-5 inhibitors (PDE-5i) have frequently observed. New synthetic analogues obtained from the chemical modification of parent compounds are frequently found in illicit products despite continuous efforts to inspect for these adulterants. A rapid and accurate method based on quadrupole-Orbitrap mass spectrometry was developed for simultaneously confirming and quantifying 85 PDE-5i and derived analogues present in illicit products for erectile dysfunction (ED). Common ions of PDE-5i according to their similar structures were proposed based on MS/MS fragmentations. These common ions could be an important diagnosis of their presence targets or new emerging analogues in supplements. Several validation parameters were employed, resulting in a limit of detection and quantification of 0.09–8.55 ng/mL and 0.24–17.10 ng/mL, respectively. The linear correlation coefficient (r²) was higher than 0.995, and mean recoveries of target compounds were in the range of 82–118%. A total of 187 illicit products, obtained from on/offline markets over a period of 3 years (2015–2017), were screened by the established method. Approximately 53% of them were adulterated with PDE-5i or derived analogues at concentrations of 0.1–726.0 mg/g in the illicit products. In the interests of public health, this study describes a rapid and accurate method to determine PDE-5i and new emerging analogues in adulterated products.     

Development of a specific fragmentation pattern-based quadrupole-Orbitrap™ mass spectrometry method to screen drugs in illicit products

Over the past decade, illicit drugs have been founded in marketed products, which pose a risk to public health. In particular, newly designed analogues synthesized by chemical modification of parent compounds to avoid detection by authorities are frequently detected worldwide. Although many analytical methods for determination of drugs have been reported, analytical methods using high-resolution mass spectrometry, which has the advantage of rapid screening and accurate identification of new substances, are necessary to control illicit drugs in marketed products. In this study, a rapid analytical method using an Orbitrap™ mass spectrometer for identification of illicit drugs in marketed products was developed. The 32 drugs were classified as benzodiazepine-, synthetic cannabinoid-, amphetamine- and benzylpiperazine-type drugs according to their chemical structures, and from their fragmentation patterns in tandem mass spectrometry spectra of an established method. The method validation gave a limit of detection of 0.06–5.30 ng/mL and a limit of quantification of 0.18–16.50 ng/mL, high linearity (R² > 0.994) and mean recoveries of spiked matrix-blank samples ranging from 83.7% to 117.1%. Approximately 71% of 21 samples collected over 3 years were found to individually contain one of four types of benzodiazepines or two different synthetic cannabinoids. In one case, levels as high as 827.2 mg/g were measured suggesting adulteration at high levels, which suggests that potential illicit products containing drugs should be regularly screened to protect public health.     

When a Commercial is Not a Commercial: Advertising of Violent Entertainment and the First Amendment

The September 2000 release of the Federal Trade Commission's report on the marketing of violent entertainment to children ignited the latest of many rounds of policy debates on violent entertainment and its effects on children. Parties on both sides of the debate have cited the First Amendment as limiting what the government can do to legally restrict the marketing of violent entertainment products to children. However, little detailed analysis of just how the First Amendment would apply to any such marketing restrictions has been presented. That is the subject this article takes up. First, it looks at the First Amendment standard of review applied to restrictions on commercial speech. The article also considers whether violent speech, in either entertainment programming or its advertising, may be restricted under the First Amendment. Finally, this article examines whether the advertising of violent entertainment products is entitled to the same level of First Amendment protection afforded to the products being advertised.     

Profiler Plus试剂盒扩增Amelogenin基因座变异1例

目的探讨日常检案及DNA数据库建设中常用的ProfilerPlus系统扩增法医生物检材可能出现的变异情况。方法分别采用ProfilerPlus试剂盒扩增、毛细管电泳分析及Amelogenin单基因座扩增、银染技术分型两种方法分别检测两份血痕的基因型。结果应用ProfilerPlus试剂盒扩增、毛细管电泳分析发现X-Y同源Amelogenin基因座的X片段丢失,而运用Amelogenin单基因座扩增、银染技术分型则X片段正常出现。结论应用ProfilerPlus系统分析法医生物检材,有可能出现等位基因丢失现象,此现象需要引起我们在日常检案及DNA数据库建设中的足够重视。     

Definition of primary mode of action of a combination product. Final rule

The Food and Drug Administration (FDA) is amending its combination product regulations to define "mode of action' (MOA) and "primary mode of action" (PMOA). Along with these definitions, the final rule sets forth an algorithm the agency will use to assign combination products to an agency component for regulatory oversight when the agency cannot determine with reasonable certainty which mode of action provides the most important therapeutic action of the combination product. Finally, the final rule will require a sponsor to base its recommendation of the agency component with primary jurisdiction for regulatory oversight of its combination product by using the PMOA definition and, if appropriate, the assignment algorithm. The final rule is intended to promote the public health by codifying the agency's criteria for the assignment of combination products in transparent, consistent, and predictable terms.     

Economic Effects and Spin-offs in a Small Space Economy: The Case of Canada

Canada, through a well-focused space program (telecommunications, earth observation, robotics), has succeeded in developing a space industry largely based on SMEs. The result has been significant economic benefits and technological spin-offs. In this article, the results of two programs, the ESA (European Space Agency) and the STEAR (Strategic Technologies in Automation and Robotics), are compared.The ESA program has generated significant indirect effects and spin-offs for Canadian exports. ESA's reputation and network have enabled SMEs to increase export sales of both space products and other commercial products derived from space technologies. The STEAR program has been highly successful in promoting a new generation of SMEs for space robotics, encouraging both spin-in and spin-offs of technologies. The analysis highlights the complementarity of mission- and diffusion-oriented programs in the technology transfer process.     

The determination of cocaine in hair: a review

The explosion of literature related to the analysis of hair for cocaine and its products is reviewed. In the commonly accepted applications of hair testing for cocaine, those related to criminal or civil investigations and pharmacotoxicologic studies occupy most of the relevant published work. This review uses detailed, ‘binary’ (yes/no) tables to demonstrate trends in the literature, and allows researchers and caseworkers quick access to the literature most important for answering a variety of questions.     

Cue utilization in the product authentication process: a framework and research agenda for product counterfeit prevention

Scholars suggest that consumers rely on heuristics to evaluate products. They employ both extrinsic and intrinsic cues to evaluate product quality and utilize the same cues to differentiate between counterfeit and genuine products. This has far-reaching public health, economic, product authentication, and even criminal justice policy implications due to the emerging ideas of criminalizing the purchase of counterfeit goods. In order to predict the viability and the possible effects of such a policy, a thorough understanding of consumer attitudes toward counterfeits, purchase motivation, and behavior, as well as of their ability to distinguish between genuine and counterfeit goods, is imperative. Building on cue utilization theory, this article develops a framework for understanding how consumers develop and utilize heuristics for product authentication in the context of intellectual property infringements and outlines a research agenda. Additionally, it helps to inform the development of prevention and enforcement efforts, in consumer education and enforcement agent training, as well as a basis for policy decisions.     

Applications for Food and Drug Administration application approval to market a new drug; revision of postmarketing reporting requirements. Final rule

The Food and Drug Administration (FDA) is amending its regulations describing postmarketing reporting requirements to implement certain provisions of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The changes apply to drug products that are life supporting, life sustaining, or intended for use in the prevention of a serious disease or condition and that were not originally derived from human tissue and replaced by a recombinant product. The final rule implements provisions of the Modernization Act by requiring an applicant who is the sole manufacturer of one of these products to notify FDA at least 6 months before discontinuing manufacture of the drug product.     

Technology transfer in a global economy

The emergence of new technologies is acting both as a driving force and an enabling factor to globalization. At the same time, these technologies are changing rapidly, shortening the life cycles of products and the underlying processes, and raising technology costs. Technology transfer from academic and scientific institutions has thus transformed into a strategic variable for companies and nations to cope with these challenges in a global economy. This article introduces the rationale for the special issue on the role of technology transfer in a global economy. The paper summarizes the main topics and themes covered by a selection of papers and keynotes presented at the annual conference of the Technology Transfer Society in 2011, as well as providing some pointers towards a future research agenda.     

THCVA-A - a new additional marker for illegal cannabis consumption

The aim of the present investigations was to find markers for differentiating between the consumption of illegal cannabis products and legal medication containing fully synthetic Δ9-tetrahydrocannabinol (Δ9-THC), e.g., Marinol capsules. Δ9-Tetrahydrocannabinolic acid A (Δ9-THCA-A) and Δ9-tetrahydrocannabivarinic acid A (Δ9-THCVA-A) were taken into consideration for analysis, because these substances are the precursors of Δ9-THC and Δ9-tetrahydrocannabivarin (Δ9-THCV) in plant material of Cannabis sativa and are not contained in medical THC formulations. Whereas Δ9-THCA-A is an already well investigated substance, there is little analytical data on Δ9-THCVA-A. The reason for the presented investigations was a case in which a man was tested positive for Δ9-THC during a routine traffic control claiming that the positive serum sample resulted from the intake of a THC medication (Marinol) and not from consuming illegal cannabis products. Sample preparation consisted of a protein precipitation with acetonitrile. Analysis was carried out on a Thermo Fisher LCQ Deca ion trap LC-MS-MS-system using electron spray ionization (ESI) in negative mode. MS(2)- and MS(3)-full scan spectra were recorded for Δ9-THCA-A and Δ9-THCVA-A starting from [M-H](-). Reference spectra were obtained by measuring a Δ9-THCA-A reference solution and an ethanolic cannabis extract for Δ9-THCVA-A as there is no reference material for this cannabinoid available on the market yet. Main transitions for Δ9-THCA-A were m/z 357→313 and 339 in the MS(2)-spectrum and m/z 313→245 and 191 in the MS(3)-spectrum. Fragmentation pattern of Δ9-THCVA-A was identical with a difference of 28 amu less for the precursor ion as well as the fragments due to a shorter alkyl side chain in the molecule (MS(2): m/z 329→285 and 311; MS(3): m/z 285→217 and 163). The two plant cannabinoids Δ9-THCA-A and Δ9-THCVA-A could be detected in the serum sample by LC-MS-MS which proved the intake of illegal cannabis products derived from plant material of C. sativa in the described case.     

Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; amendment of final monograph for OTC antitussive drug products. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is issuing a final rule amending the final monograph for over-the-counter (OTC) antitussive drug products (products that relieve cough). Use of topical/inhalant products containing camphor or menthol near a flame, in hot water, or in a microwave oven may cause the products to splatter and cause serious burns to the user. As part of its ongoing review of OTC drug products, FDA is adding warnings and directions to inform consumers about these improper uses and is amending its final regulations for OTC drug labeling requirements to add this new flammability warning for antitussive drug products containing camphor or menthol.     

Cancellation of a trade mark based on a prior foreign geographical indication related to different products

The registration and the use of a composite trade mark includinga famous geographical indication (GI), for products differentto those covered by the GI, are acts of unfair competition insofaras they allow the trade mark owner to free-ride on the GI'sreputation, causing its dilution.     

Labeling of diphenhydramine-containing drug products for over-the-counter human use. Final rule

The Food and Drug Administration (FDA) is issuing a final rule amending the final monographs for over-the-counter (OTC) antiemetic, antihistamine, antitussive, and nighttime sleep-aid drug products to add a warning statement for oral products containing diphenhydramine citrate or diphenhydramine hydrochloride. The warning advises consumers not to use oral OTC diphenhydramine products with any other product containing diphenhydramine, including products used topically. This final rule also includes the agency's conclusions on additional warning statements and a direction statement for OTC external analgesic drug products containing diphenhydramine hydrochloride. These conclusions will be incorporated into the final monograph for OTC external analgesic drug products in a future issue of the Federal Register. FDA is issuing this final rule after considering public comments on the agency's proposed regulation and all new data and information on drug products containing diphenhydramine that have come to the agency's attention     

The role of people in information-sharing: perceptions from an analytic unit of a regional fusion center

Information sharing research has largely focused on capturing operational practices related to the exchange of information. A noticeable shortcoming of this developing literature is the lack of scholarly attention focused specifically on analytic personnel. The present study employs semi-structured interviews with 23 personnel that comprise the analytic unit within a regional fusion center located in a large metropolitan area in the United States. Findings indicate that there is significant ambiguity surrounding the organizational and geographic audiences to which intelligence products should be tailored. Moreover, it appears information sharing is sparse and reliant upon personal relationships between analysts and external organizations. Lastly, analysts do not receive feedback pertaining to the content and effectiveness of intelligence products created. These findings may be generalized to other analytical organizations whose primary goal is to gather, analyze and disseminate intelligence. Action steps for policymakers are provided.     

500年木乃伊的DNA分析

目的对干尸DNA的分析,为法医进行陈旧检材分析积累经验。方法用经典的酚/氯仿提取DNA,WizardDNAclean-upsystem纯化,用PromegaPowerplus16system进行PCR,扩增STR,将线粒体DNAhv1区分别用三对重叠的引物进行全序列测定。结果STR位点图谱清楚,线粒体DNA测序结果理想。结论此法用于陈旧检材DNA分析,结果理想。