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Power gradients are at the very center of drug regulation and must be considered for their own sake buy cheap nimodipine 30mg online. It is a general feature of the construction of economic markets that it cannot proceed without state and administrative interventions discount nimodipine 30 mg amex, which built the terrain upon which capital can be invested and goods traded 30 mg nimodipine mastercard. In the case of drug mass production, this interplay between the economical and the political may be extended to the cultural since the construction of therapeutic markets rests on local visions of diseases that do not only defne their nature but also their hierarchy. The hypothesis the various papers assembled in this collection seek to investigate is that a long 20th century beginning around 1880 has seen the emergence and the articulation of four ways of regulating. The idea of various “ways of regulating drugs” should not be understood as targeting a series of structure chronologically distributed. It is rather a heuristic model, focusing on the dynamics of social action, useful to bring some order in the multiplicity of regulatory practices mentioned above. The notion of ways of regulating seeks to bring to light the inner logic of specifc combination of practices and procedures, describing the various rationalities implicated in the management of therapeutic agents. The approach therefore link the peculiar social worlds involved in regulation, the forms of evidence and expertise they mobilized and the means of intervention they choose or establish. Like Pickstone’s ways of knowing ways of regulating are historical products: they have not existed in all eternity, they appeared at some point in history, none ever disappeared but their arrangements and articulation have been utterly variable. Ways of regulating are therefore categories or frames used in thinking about, choosing between and organizing practices that are not “given” but constructed in a given situation, each represent a “grammar of action” that operate in combination rather than in isolation. The dynamics of a peculiar form of regulation should therefore be discussed at different levels, taking into account the following questions: which values guide the regulation process? Given these entries, we make the proposal that drug regulation, in a long 20th century beginning in the 1870s, can been characterized by the gradual emergence of four ways of regulating. As previously outlined, the professional regulation of drugs originates in the 19th century corporative organization of pharmacy. In continental Europe, it evolved out of a state delegation of expertise, which granted graduated pharmacists with a monopoly over the sales and the preparation of the therapeutic agents included in the national pharmacopoeia. Such regulation was justifed as a means to avoid unnecessary competition among pharmacists as well as a means to eliminate the entry of supposedly untrained and unskilled practitioners on the market. Professional governance emanates from corporations, pharmaceutical societies and their medical counterparts, eventually supplemented with special committees of experts set up by academic journals or public health authorities. Within this confguration, the judgment about the value of specifc drugs focused on the production of pharmacological knowledge linking dosage, concentration within the body, pattern of elimination, and the balance between toxic and 10 Introduction therapeutic responses. In addition to the traditional pharmacopoeia, which defned regulatory tools include the many forms of guidelines and recommendations for practice issued by collectives of pharmacists and/or physicians. During the frst decades of the 0th century, this dynamics of professional regulation was less and less able to cope with the gradual transformation of many workshops into proper factories, with the development of industrial specialties, and with the growing competition between pharmaceutical frms and chemical corporations. Academic pharmacists often perceived ready- made specialties as the reign of secrecy, economic greed, bad quality, unproven effcacy and marketing lies. If the leaders of the profession often maintained a more ambiguous attitude toward mass-production, they nonetheless supported the adoption of measures like special systems of authorization that would have limited the introduction of specialties, and if possible placed them under the control of the profession. Such attempts were rarely successful until the above-mentioned marketing permits were introduced albeit with a different purpose, but they triggered important changes within the producing frms. Standardization and quality control became the slogans of a new industrial regulation, which combined two different aims. The frst one was to maximize the creation of economic value by reducing the consumption of raw materials and increasing the productivity of manufacturing work. The second aim was to ensure that preparation errors would not result in sales triggering complaints, bad reputation and – worse - direct liabilities. Within this perspective, regulation became a problem of technology and proper management. It targeted the elimination of bad habits and bad products through surveillance, but also the organization of markets. From the 19 0s onward, a growing panoply of interventions for infuencing prescription practices, gaining clinical knowledge and defning drug uses was developed within the largest frms, including inserts in medical journals, brochures, in-house periodicals, seminars for prescribing physicians, product representation and visits. The third way of regulating needs less emphasis has it has been extensively discussed. It is the administrative regulation, whose nature radically changed in the 20th century as the global delegation of expertise to the profession described above ceased was less and less accepted as the one best way to foster the qualities of a good drug system: innovation, access and effcacy. The existing historiography has outlined the role “affairs” and public debates originating in adverse events like the thalidomide scandal have played after 1945 for displacing the centers and changing the practices of regulation. The most important transformation was to make the state bodies themselves responsible not only for some post hoc registration of consensual professional opinion, but to turn them into centers of expertise shaping as well as assessing facts, eventually disposing of their own experts, of real although limited means of investigation. When looking at aims and means of intervention, one decisive feature of the new administrative regulation is 11 Jean-Paul Gaudillière and Volker Hess its focus on both safety and effcacy. In the name of public health agencies and governmental bodies have been granted the power to accept or deny marketing permits not only on the basis of pharmacological considerations about side-effects and therapeutic dangers but as well on the basis of suffcient or insuffcient statistical evaluation of clinical utility.

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The diversity of variables involved in a systematic study of response to reduced environmental stimulation makes for considerable complexity cheap nimodipine 30mg otc. It will be useful to take a brief overview of procedures employed by various investigators nimodipine 30 mg with visa. In the first of these buy 30 mg nimodipine mastercard, efforts were directed toward an absolute reduction of input to the organism from the external world. Lilly (50) immersed two subjects up to three hours in a tank of slowly circulating tepid water, wearing nothing but a head mask that covered eyes and ears. Subjects received an initial set of training exposures to overcome fear of the situation. On the day of the experiment, they were placed in the tank and were instructed to inhibit all movement so far as possible. Although absolute reduction in sensory input is the goal here, this latter method places less of a restriction on motor activity. A second approach to reducing sensory stimulation was used by Bexton, Heron and Scott (8). They reduced patterning of sensory inputwhile retaining levels of input at near normal. In this procedure using twenty-two male college students, the subject wore a pair of translucent goggles that permitted the perception of light but not of objects. Auditory input consisted of the masking sound of fan and airconditioner motors, and tactile experience was reduced through the use of cuffs and gloves that permitted no direct exploration of the immediate surroundings. In this procedure goggles are not used and the subject is exposed to normally patterned vision of a highly restricted environment. Wexler, Mendelson, Leiderman, and Solomon (80) placed seventeen subjects into polio tank respirators with arms and legs in cardboard cuffs. The repetitive drone of the respirator motor provided an auditory masking sound, whereas the visual environment consisted of the front of the respirator and the blank walls of a screen. Since the ports of the respirator were left open, subjects breathed for themselves. This procedure relies on monotony to achieve its effects and is thus similar to situations in which highly repetitive simple tasks are performed. It is also most similar to the environment of the prisoner in solitary confinement as well as other isolation situations as encountered in real life. Without attempting a comprehensive survey of methodological problems and issues, some examination of the choices confronting researchers in this problem area may be helpful. Efforts at the absolute reduction of sensory input are limited by the impossibility completely of doing away with sensory experience in a living conscious organism. Even the most sophisticated instrumentation cannot eliminate sensations and perceptions arising from internal body functions. To the extent to which this goal is relevant to testing a variety of hypotheses, it can only be approximated. Few if any investigators have attempted a rigorous definition of the terms they have employed. Most have used their experimental methods to provide an empirical basis for their conceptions. Indeed it is understandable that the number of descriptive terms and phrases in the literature is almost as large as the number of investigators. Without becoming too deeply embroiled in the sensation-perception issue, it may be useful to think of attempts at the absolute reduction of intensity of input to the organism as sensory deprivation, whereas reduced patterning and monotony may be more meaningfully seen as perceptual deprivation. The outstanding characteristic of the latter two approaches appears to be the decrease in the structure and variety of input. The term "isolation" is one which seems to be relevant to the social dimension rather than to the sensory and perceptual aspects of the various experimental conditions employed. At this stage of -56- our knowledge, it is unclear as to whether there are different behavioral consequences of sensory as opposed to perceptual deprivation, in the sense used above. It is possible to conceive of this range of stimulus conditions as a complex continuum. In view of the unique complexities presented by research in this area, it is clear that somewhat arbitrary choices of procedure have been made. These choices must be evaluated in terms of the limitations they impose on the results obtained. Thus the observation of cognitive and perceptual functioning and the descriptions of emotional and affective changes makes simultaneous verbal reports of experience in the experimental situation most desirable. Retrospective reports raise difficult questions about their accuracy and make it impossible to study the concurrence of physiological events and verbal behavior.

Paroxetine may cause an increased risk of metoprolol adverse effects (shortness of breath discount nimodipine 30 mg on-line, bradycardia buy nimodipine 30 mg amex, hypotension discount nimodipine 30mg, acute heart failure) through inhibition of cytochrome P450. An exaggerated hypotensive response to the first dose of the α-blocker, phenoxybenzamine, can occur. Propafenone may cause metoprolol toxicity through decreased metoprolol metabolism. Quinidine may cause bradycardia, fatigue, and shortness of breath through decreased metoprolol metabolism or clearance. These following general measures can be used if overdose or toxicity is suspected: Elimination of the drug: gastric lavage should be performed within 1 hour of administration Bradycardia/hypotension: for bradycardia, atropine should be administered. Alternatively, a high- dose dobutamine infusion may be used to overcome the β- blockade. In addition, carvedilol has been shown to inhibit the action of oxygen-free radicals and to demonstrate antiproliferative effects on smooth muscle cells. Note: Because of increased elimination of carvedilol in pediatric patients, three times daily dosing and a higher target dose per kilogram may be needed in children younger than 3. One study suggests that carvedilol therapy be initiated with approximately 20% of the normal dose in patients with 144 C. Note: patients with cirrhotic liver disease achieved carvedilol serum concentrations four- to seven-fold higher than healthy patients after a single dose Pharmacokinetics Carvedilol has an onset of action of α-blockade within 30 minutes and of β-blockade of within 1 hour. It is metabolized predominantly by aromatic ring oxidation and glu- curonidation, and oxidative metabolites undergo conjugation via glucuronidation and sulfation. Drug-Drug Interactions Interaction with amiodarone may cause a theoretical risk of hypotension, bradycardia, and cardiac arrest. Cimetidine may cause increased adverse effects of carvedilol (dizziness, insomnia, gastrointestinal symptoms, postural hypotension). Abrupt withdrawal of clonidine while taking a β-blocker may exaggerate the rebound hypertension because of unopposed α-stimulation. An exaggerated hypotensive response to the first dose of the α-blocker phenoxybenzamine may occur. Adverse Effects Carvedilol is usually well tolerated, however, caution is warranted in this subset of patients with moderate to severe heart failure because it may 6. Abrupt withdrawal of β-blockers from some patients with angina pectoris may markedly increase the severity and frequency of the angina and result in severe cardiovascular problems (myocardial infarction, arrhythmias, and sudden death). Propranolol Indication Propranolol is a noncardioselective β-blocking agent with equal effects on β1 cardiac and β2 receptors. Kazmerski adverse effects of propranolol, including bronchospasm, hypoglycemia, and peripheral vasoconstriction. The maxi- mal dose may be increased to 80 mg, three times daily (20% of patients) Hypertrophic subaortic stenosis: 20 to 40 mg, three or four times daily, oral Dosage adjustment in hepatic impairment: propranolol is almost entirely eliminated by hepatic metabolism and, thus, patients with liver dis- ease may require variable dosage adjustments and more frequent monitoring. However, the basic approach of dosage titration to the desired therapeutic response will not be altered Pharmacokinetics Propranolol is almost completely absorbed from the gastrointestinal tract, but is subject to considerable hepatic tissue binding and first-pass metabolism. Propranolol is highly lipid soluble and crosses the blood-brain barrier and the placenta. Abrupt withdrawal of β-blockers in patients with angina pectoris may markedly increase the severity and frequency of the angina and result in severe cardiovascular problems (myocardial infarction, arrhythmias, and sudden death). Esmolol is often used in the acute management of children with arrhythmias and/or hypertension; however, pharmacokinetic studies of esmolol in children have been limited. Plasma norepinephrine levels in infants and children with congestive heart failure. Arrhythmogenesis and contractile dysfunction in heart failure: Roles of sodium-calcium exchange, inward rectifier potassium current, and residual beta-adrenergic responsiveness. The randomized evaluation of strategies for left ven- tricular dysfunction pilot study. Efficacy and safety of metoprolol in the treatment of doxorubicin-induced cardiomyopathy in pediatric patients. Beta blocker treatment of dilated cardio- myopathy with congestive heart failure in children: a multi-institutional experience. Carvedilol as therapy in pediatric heart failure: an initial multicenter experience. Prospective single-arm protocol of carvedilol in children with ventricular dysfunction. Results of therapy with carvedilol, a beta-blocker vasodilator with antioxidant properties, in hypertensive patients. Carvedilol therapy in pediatric patients with conges- tive heart failure: a study investigating clinical and pharmacokinetic parameters.

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Covalent attachment of apolipoprotein A-I and apolipoprotein B-100 to albumin nanoparticles enables drug transport into the brain effective 30 mg nimodipine. Evaluation of gliadins nanoparticles as drug delivery systems: A study of three different drugs discount nimodipine 30mg fast delivery. Ganciclovir-loaded albumin nanoparticles: Characterization and in vitro release properties order nimodipine 30 mg with amex. Albumin nanospheres as carriers for passive drug targeting: An optimized manufacturing technique. Oligonucleotide-protamine-albumin nanoparti- cles: Protamine sulfate causes drastic size reduction. Understanding the nanoparticle-protein corona using methods to quantify exchange rates and affinities of proteins for nanoparticles. Nanoparticle size and surface properties determine the protein corona with possible implications for biological impacts. Gamma interferon loaded onto albumin nanoparti- cles: In vitro and in vivo activities against Brucella abortus. Targeting study of gelatin adsorbed clodronate in reticuloen- dothelial system and its potential application in immune thrombocytopenic purpura of rat model. An enzyme-linked immunosorbent assay for the detection of autoantibodies to albumin. Gelatin-specific humoral and cellular immune responses in children with immediate- and nonimmediate-type reactions to live measles, mumps, rubella, and varicella vaccines. Preparation of sub-100 nm human serum albumin nanospheres using a pH-coacervation method. Vascular permeability in a human tumor xenograft: Molecular size dependence and cutoff size. Receptor mediated targeting of lectin conjugated gliadin nanoparticles in the treatment of Helicobacter pylori. Human serum albumin nanoparticles for efficient delivery of Cu, Zn superoxide dismutase gene. Gold Nanoparticles and Surfaces: Nanodevices for Diagnostics and Therapeutics Hariharasudhan D. Chirra, Dipti Biswal, and Zach Hilt Department of Chemical and Materials Engineering, University of Kentucky, Lexington, Kentucky, U. The use of gold as a key component in biodiagnostic and therapeutic fields has emerged pri- marily over a period of three decades, though it has been used for centuries for artistic purposes. Gold is known to be the main ingredient for the preparation of an ancient Roman elixir of life. An example of a historical use of gold was in the coloring of glass during the 17th century to produce intense shades of yellow, red, or brown depending on the concentration of gold. In 1842, colloidal gold was used in chrysotype, a photographic process to record images on paper. During the 19th century, the pure form of gold called activated gold, due to its inert behavior to harsh environments, was prominently employed for catalysis (1). With the advent of numerous tools, techniques, and concepts related to nanotechnology, in combi- nation with the inherent property of gold to form functionalized bioconjugates via simple chemistry, gold has found importance in various biodiagnostic and thera- peutic applications (2–6). Herein, we detail the progress made in the functionaliza- tion of gold surfaces, both planar and particulates, at the nanoscale for diagnostic and therapeutic applications. Although gold can be directly used for biomedical applications, unique applications of this inert metal require functionalization with other biomolecules or biocompati- ble polymeric systems. The presence of an appropriate stabilizing agent prevents particle agglomera- tion by binding to the particle surface to impart high stability and also rich linking chemistry if it acts as a functional group for bioconjugation (8–10). The functionalization of gold surfaces can be achieved by using either “graft- ing to” or “grafting from” methods (Fig. Initially, grafted polymer layers over these active sites, however, hinder the further attach- ment of polymer chains because of limited availability of more active sites, thus limiting film thickness and brush density. In the “grafting from” approach, a reac- tive unit on the surface initiates the polymerization, and consequently the polymer chains grow from the surface. Most “grafting from” polymerization reactions uti- lize controlled radical polymerization mechanisms. Since monomers diffuse more easily to reactive sites than macromolecules, this approach generally leads to higher grafting densities. A variety of functionalization techniques over gold surface are described in the following text. The thiol gold chemistry is used as the key mechanism for graft- ing small biomolecules and short-chain, end-functionalized polymeric stabilizers to gold. Murray and his colleagues extended Schiffrin’s method to diversify the functionality of monolayer-protected clusters to mixed monolayer-protected clus- ters by using a place-exchange reaction between the thiols (13).

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