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The use of Raman spectroscopy in the detection of counterfeit and adulterated pharmaceutical products cheap 1 mg finax with amex. Identifcation of the “wrong” active pharmaceutical ingredient in a counterfeit Halfan™ drug product using accurate mass electrospray ionisation mass spectrometry cheap 1 mg finax otc, accurate mass tandem mass spectrometry and liquid chromatography/mass spectrometry. Countering the Problem of Falsified and Substandard Drugs 7 An International Code of Practice for Falsifed and Substandard Medicines Ensuring a safe, reliable drug supply is ultimately a matter for indi- vidual countries. To this end, every nation has four main responsibilities: regulating the responsible manufacture of safe and effective medicines; pre- venting falsifed and substandard drugs from entering the market; detecting them when they do; and punishing those who knowingly manufacture and trade them. Executing these responsibilities requires strong national systems for drug regulation, surveillance, and law enforcement. Governments must work with key stakeholders in industry, professional associations, and civil society to protect the drug supply. However, no country acting alone can protect its citizens from falsifed and substandard medicines. The problem, as seen throughout this report, is international, fueled by international trade and telecommunications. Crime and easy money are powerful forces driving the illegitimate medicines busi- ness. Its perpetrators gravitate to countries where surveillance, regulation, and law enforcement are the weakest. They take advantage of international manufacturing and trade to produce and sell their products in the global market. The interconnectedness of modern manufacturing systems makes the “quality and safety of goods. A coherent system of global governance founded on diplomacy and international co- operation can improve product safety and protect health around the world (Gostin and Taylor, 2008). This will require cooperation among countries, among agencies within governments, and among consumers, manufactur- ers, professional associations, and civil society groups. An emphasis on the public health risks of illegitimate drugs is central to framing this problem; protecting drug companies’ proprietary interests is not. In the past, disagreements about the overlap between public health protection and intellectual property guarantees have crippled international discussion on drug safety. Any global governance process will need to focus on public health, a goal all parties can support and come to consensus around. Global governance includes hard law, such as treaties, and soft law, such as resolutions, declarations, memorandums of understanding, and codes of practice (Gostin, 2013). If countries or regions wish to negoti- ate a treaty on falsifed and substandard drugs, then they should do so, but international soft law may be a more practical short-term solution to the problem. A soft-law solution could encourage international momentum for drug regulation, surveillance, and law enforcement. It would also build trust among stakeholders and pave the way for a future hard-law solution if necessary. Two treaty processes already under way relate to the problem of substandard and falsifed medicines. The Council of Europe’s Medicrime Convention (offcially, “the Convention on the counterfeiting1 of medical products2 and similar crimes involving threats to public health”) is a multi- lateral treaty intended to prevent the public health threats of illegitimate medicines (Council of Europe, 2011). The convention aims to make crimes of drug adulteration and of the intentional manufacture, supply, or trade in illegitimate medicines or ingredients, and their accessories (Council of Europe, 2011). Other criminal offenses under Medicrime include tamper- ing with the drug pedigree or making false drug documents; putting an unauthorized drug on the market; and intentionally aiding or abetting a criminal in one of the named offenses (Council of Europe, 2011). Med- icrime also gives terms for protecting victims, including victim’s rights to compensation from perpetrators, and for international cooperation in investigation, extradition, and mutual legal assistance (Council of Europe, 2011). By December 2012, 22 countries had signed the convention, but only Ukraine had ratifed it (Council of Europe, 2012). Medicrime will not come into force until fve countries ratify it, including three Council of Europe members (Council of Europe, 2011). Critics of the convention see in Medicrime an attempt to treat routine 1 The Medicrime Convention defnes a counterfeit as a false representation of identity or source (Council of Europe, 2011). And, though Susanne Keitel, the director of the European Directorate for the Quality of Medicines, explained to the committee in March that the Medicrime Con- vention does not cover infringement of intellectual property rights, some see hostility to generics companies in the treaty (Attaran and Bate, 2010).

Additionally cheap finax 1 mg, use information finax 1 mg low cost, lack of statistical power to hydrochlorothiazide was frequently given with evaluate efect modifcation by sunlight-related amiloride, and there were too few subjects to factors, and failure to report the risk estimate for evaluate the efects of therapy with hydrochlo- hydrochlorothiazide. Te analysis included 10 692 indi- the participant and partly by a dermatology viduals, largely Caucasian, with no diuretic department. Basal cell carci- squamous cell carcinoma, 602 cases of basal nomas were identifed by general practitioners cell carcinoma, 360 cases of cutaneous malig- and linkage with the national cancer registry nant melanoma, and 1550 controls. Afer adjustment for multiple consecutive patients, recently diagnosed (within potentially confounding factors, no excess risk 3 months of study entry), aged 18 years or older, of basal cell carcinoma was observed with either from one of the participating dermatology prac- cumulative duration of use or average grams of tices. Cases or to hypertension, since use of other cardio- and controls were excluded if they were unable vascular drugs, e. Data with at least one prescription for thiazide flled on thiazide use up to 6 months before diagnosis between 1969–1973 who were followed for cancer (and a matched date for controls), were abstracted until 2002 A total of 55 observed versus 40. Odds able on potentially confounding or modifying ratios did not increase with estimated number of factors. For women, the Two case–control studies of cancer of the age-adjusted relative risk estimate was 1. Te result was not altered with women with cancer of the breast (diag- when using updated information on thiazide use. As in other biopsy during participation in the programme) studies, it was not possible to exclude the possi- (Stanford et al. Response rates were 86% bility of confounding by hypertension, since for cases and 74% for controls. Self-reported use hypertension is a major indication for hydro- of thiazides for at least 6 months compared with chlorothiazide use. Hypertension was reported women without a history of hypertension was to be an independent risk factor for renal cell associated with an age-adjusted odds ratio of carcinoma in this study. Controls followed for cancer until 1976 using hospital-dis- (n = 1007) were identifed through Center for charge records for the programme and the cancer Medicare and Medicaid services, and cases were registry,Friedman & Ury (1980)found an elevated limited to those who were registered in this age- and sex-standardized morbidity ratio for system. In-person interviews encom- subsequent analysis, with follow-up data until passed a detailed history of cardiovascular 1988, van den Eeden & Friedman (1995) reported medications used, and included duration and a greater than expected incidence of tumours of dose, using a life-events calendar and photo- the gall bladder with thiazide use (16 observed, graphs of medicines to enhance recall. Additionally, among women who reported use of thiazides for in the 1995 study, other hypertension drugs also 6 months or more compared with women who 302 Hydrochlorothiazide had never used any antihypertension medica- of thiazides for at least 6 months was 1. However, none changed the estimate and mortality from cancer until 1996 using the by more than 10%, and thus estimates were only Israel population registry and national cancer adjusted for age. Te lack of nent pacemaker implantation, cerebrovas- clear trends with duration could be due to poorer cular disease, chronic hepatic or renal disease, recall for use further in the past, or to lack of a peripheral vascular disease, malignant disease, true association. An elevated incidence of cancer of conducted in six counties in northern New the colon was observed among those who used Jersey. Age, sex, smoking status, and be aged 21 years and over and residing in one triglycerides were included in the models if they of the six counties (Bergen, Essex, Hudson, were statistically signifcant using stepwise Cox Middlesex, Morris, and Union). Afer adjustment precise method of ascertaining medication use for multiple potentially confounding factors, was not explained and was assumed to be derived including age, sex, level of education, smoking, from the intake examination. Given that the body mass index, hypertension, diabetes, and cohort was part of a clinical trial, the results may use of other drugs, the overall odds ratio for use not be generalizable. No signifcant increases in the incidence the Danish cancer registry, and drug use was of any neoplasms were seen in females. Te odds fndings may have been the result of an unusu- ratio for all cancers combined was 1. Te Working Group cation as other antihypertension drugs also were noted that no data on historical controls were related to overall cancer incidence. Te rats were observed until natural death In a feeding study, groups of 50 male and or moribundity occurred, or the end of the study 50 female mice (age, 7–8 weeks) were given diets at 130 weeks. No dose (9 out of 50 versus 4 out of 48) was not statis- statistical analyses of the incidences of preneo- tically signifcant (P = 0. Te icant, dose-related increases in the incidence incidence of adrenal pheochromocytoma was of hepatocellular adenoma, and hepatocellular increased [P < 0. No signifcant increases in neoplastic completion of the 105–106-week exposure period or preneoplastic lesions were reported.

The history of Madaus thus reveals a culture of preparation that shares many aspects with the practices at Dausse finax 1 mg discount, including the organization of plant collection and breeding order finax 1mg fast delivery, mechanical innovations, a deep interest in physiological tools, and research. The social and intellectual landscape within which the frm blossomed was not the French professional order, but a rare combination of industry and alternative medicine. Madaus’s holistic approach of the living, which nurtured a system of correspondences among plants, animals, and human beings, than the integration of alternative medical practices – homeopathy, as well as the use of plants and organ extracts – into the industrial regulatory order and its values of productivity, standardization, and homogeneity, all of which were taken as synonymous of quality and effectiveness. The consequences were not only the prominent role attributed to mechanics and processing, but the mobilization of pharmacology and chemistry 63 Jean-Paul Gaudillière for quality control. As a company looking for a more scientifc form of popular and biological medicine, Madaus paradoxically engaged in the development of as many standards and assays as more molecularly oriented frms like Schering or Hoechst. The tensions brought about by this transformation of therapeutic agents previously associated with forms of medical practices stressing the individual and constitutional nature of disease into mass-produced and prescription- ready pills are easy to perceive, but remain to be analyzed. Similarly, comparison between Madaus and Schering highlights the commonalities of the industrial regulation of drugs. Both frms developed in-house research facilities focusing on physiology, both focused on biological assays as privileged tools of intervention, both invented relations with physicians and local practitioners that linked science and marketing. The correlate of standardization and quality control within the frms was a pattern of state interventions that echoed and reinforced entrepreneurial interventions (a situation powerfully illustrated with the regulation of sera) but did not constitute an autonomous administrative way of regulating. While substantiating the idea of an industrial way of regulating, such parallels do not make the differences between the innovation culture of both frms less real. Even when investigating cellular metabolic pathways, Schering’s strategy remained to turn extracts and sex-hormone preparations into pure molecules, while Madaus’s ambition was to make the biological complexity visible, relying on ecological investigations, mélanges, and the mobilization of local healers’ therapeutic experiences. In the end, this pervasiveness of industrial regulation in Germany provides a possible explanation for what is otherwise diffcult to understand, namely the contrasted fate of herbal medicine in both countries. The 1936 reform granting Heilpraktiker a legal status is usually understood as an example of profession building that mimicked the history of school medicine, benefting from a peculiar political window originating in the Nazi’s initial love for alternative, supposedly popular health practices, where healers were able to negotiate partial but effective institutionalization. Hence, even if after World War I French herbalists expressed their acceptance of a status as second-rank drug makers, the pharmacists’ corporate bodies blocked the path toward the recognition of a full-fedged profession, pleading for the 1941 ban. The need to take into account cognitive and material practices when analyzing drug regulation, however, points to a different path of interpretation. Pharmacists’ and herbalists’ ways of understanding the nature of drugs as well as their mode of preparation were much less dissimilar than what is traditionally assumed, a feature that reinforced the administrative nature of their competition within the system of professions. The fact that the German reform persisted once its national-socialist birth context vanished might therefore be seen as a consequence of both the declining infuence of professional regulation and the successful industrialization of “alternative” therapies in the interwar period. Following this line of analysis, the success of French pharmacists might well be rooted in the herbalists’ delayed industrialization, which left the former to think they were the only legitimate actors in trading and regulating medicinal plants. Hüntelmann The diphtheria serum was a major therapeutic innovation at the end of the 19th century. As a new form of therapy, the diphtheria serum marks the starting point for other sera like the one for tetanus or veterinary sera like red murrain. The new serum therapy promised not only a cure for diphtheria and other fatal infectious diseases, but also large profts for manufacturers who could stabilize the production process and produce serum in large quantities at industrial plants. Because detailed information about the research was freely available in well-known medical publications, health professionals trained in bacteriology could reconstruct the experiments and, there being no patent on the diphtheria serum, legally produce serum. The ambiguous legal situation, the production of serum in a free market, the prospect of large profts for the serum industry, earlier public health scandals triggered by tuberculin, the novelty of serum therapy, and the lack of information about its long-term effects – all of these factors attracted the intense interest of state offcials who hoped to minimize the potential public health risks. One of their responses was to implement and institutionalise a system of state control. In this paper I will analyse the network of actors involved in the procedures of standardization, such as test and host animals, serum, scientists, producers, state authorities, and technical arrangements. I will describe the expansion of the concept of evaluation and the standardization of veterinary sera like anthrax and red murrain. Afterwards I will describe the processes by which a serum became a state approved remedy (or not), the introduction of a new serum, the evaluation, standardization, and the institutionalization of this process. I will illustrate this with the example of the evaluation of red murrain serum and the diffculties that could be encountered in this process. The Institute for Experimental Therapy as the institutionalization of evaluation After a short period of discussion and preparation in February 1895, the “Control Station” for diphtheria serum was founded as part of a series of preventive measures, including serum 1 The paper was written as part of the research project „Vaccines and sera between laboratory, production and bureaucracy. Quality control procedures as a dynamic regulatory system between serum research, serum industry and public health policy 1890-19. Engstrom, Volker Hess, Christoph Gradmann, Ulrike Kloeppel and especially Jonathan Simon. Hüntelmann price-fxing, regulating its distribution in pharmacies, and imposing a prescription requirement.

Frequent subgraph miners such as Gaston iterate over all molecules discount finax 1mg without prescription, extracting all possible substructures per molecule finax 1mg otc. Current subgraph miners utilize several approaches to keep the number of found substructures to a minimum. One reasoning is that a larger substructure can never occur more frequently than the smaller substructures it consists of. Compared to other algorithms, Gaston is more efficient since computationally expensive operations take place in the last steps, when a large number of possible substructures has already been discarded. For a quantitative comparison of Gaston with other frequent subgraph miners, see 22 Wörlein et al. The importance of a substructure was determined by comparing its frequency against the frequency of occurrence in the control set. The most revealing substructures are those that occur frequently in one set and not in the other. As a measure of the importance of a substructure, the significance of association with one of the sets was determined by calculating the p-value of the finding. The p-value as used in this study is defined in page 3 of the Supporting Information of Kazius et al. It is the probability to find a statistical association with one of the two groups based on chance alone. On the assumption of a binomial distribution, it was calculated based on the number of ligands versus control group that were detected using that substructure. While this measure makes assumptions such as to the underlying distribution of features in each database, we still found it to be useful also in the ranking scheme described here. Using the p-value, the lists of frequently found substructures were ordered according to significance with the most-discriminating substructures at the top. The substructure with the lowest p-value was considered the most significant finding. When two substructures had the same p-value and one substructure was a substructure of the other substructure, only the larger substructure was kept. In case of substructures with equal p-values that were not substructures of each other, the larger substructures had preference over smaller ones in the list ordering. For example, if alanine and valine would be substructures with equal occurrences, and hence equal p-values, only the valine substructure would be kept in the list since alanine is a substructure of valine. In the case of a leucine instead of alanine, both substructures would be kept since neither of the two is a substructure of the other. Another important parameter in frequent subgraph mining is the minimum support value, which is the relative number of molecules a substructure should occur in to be detected by the algorithm. Lowering 75 Chapter 3 the minimum support will result in finding an equal or higher number of substructures. A higher number of substructures increase the chance of finding a substructure that is more significant. However, there is a balance between minimum support and p-value of the most significant substructure. This will be illustrated with the following example of two sets of 100 compounds each. Presume that the most significant substructure found at a support threshold of 30 compounds occurred in 60 active and 20 control compounds. Lowering the minimum support from 30 to 20 means that a new set of substructures is added to the already generated set. In theory, the most significant substructure that could be added with the new set has an occurrence of 29 active and 0 control compounds. The experiment is completed if it results in the same substructure as found in the first run. This is because a more significant substructure cannot be found by lowering the support, i.