43 resultados para Biosimilar Pharmaceuticals

em Deakin Research Online - Australia


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Consumer and patient advocacy groups (PAGs) are important participants in the politics of pharmaceuticals. Yet very little is known about the precise nature and extent of their influence. It is argued in this article that PAGs fulfil a mixed role within the health system at national and transnational levels, and that they are at times fully incorporated into economic and political power structures. Their frequent dependence on pharma industry funding is of particular concern. PAGs provide a means of direct industry interaction with the final customer, thereby partially bypassing and putting additional pressure on doctors and regulators. The article presents the case for research to establish a better empirical base for discussions about the role of PAGs within contemporary neo-liberal governance structures.

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The pharmaceutical domain represents a type of internationalised policy network theorised in recent writings on neo-liberalism, neo-corporatism and governance. This article presents an analysis of developments in prescription drug regulation in Australia. A relatively stable, state-managed pattern of interaction has been superseded by less closed exchange, and the government itself has fragmented into agencies pursuing different objectives. Developments in the three core regulatory areas are described: safety and efficacy controls, social policy (access and equity), and state support for industry (economic) development. Consensus-building occurs within the context of the National Medicines Policy. The pharmaceutical industry, represented by Medicines Australia, has a stake in all aspects of pharmaceutical policy and regulation, and draws upon unique resources (expertise and lobbying capacity). The context for the developments described is Australia's abandonment of a protectionist version of the Keynesian welfare national state in favour of the model of the competition state, which is oriented towards support for the growth of high technology industries such as pharmaceuticals, premised on partnerships with business.

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Purpose. NaCl has proven to be an effective bitterness inhibitor, but the reason remains unclear. The purpose of this study was to examine the influence of a variety of cations and anions on the bitterness of selected oral pharmaceuticals and bitter taste stimuli: pseudoephedrine, ranitidine, acetaminophen, quinine, and urea.
Method. Human psychophysical taste evaluation using a whole mouth exposure procedure was used.
Results. The cations (all associated with the acetate anion) inhibited bitterness when mixed with pharmaceutical solutions to varying degrees. The sodium cation significantly (P < 0.003) inhibited bitterness of the pharmaceuticals more than the other cations. The anions (all associated with the sodium cation) also inhibited bitterness to varying degrees. With the exception of salicylate, the glutamate and adenosine monophosphate anions significantly (P < 0.001) inhibited bitterness of the pharmaceuticals more than the other anions. Also, there were several specific inhibitory interactions between ammonium, sodium and salicylate and certain pharmaceuticals.
Conclusions. We conclude that sodium was the most successful cation and glutamate and AMP were the most successful anions at inhibiting bitterness. Structure forming and breaking properties of ions, as predicted by the Hofmeister series, and other physical-chemical ion properties failed to significantly predict bitterness inhibition.

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The aim of this study was to assess how demographic variables and personal values are related to people's knowledge and cognitive and behavioural responses towards a major drug recall event that occurred in Australia in 2003. For this purpose, a survey was sent out in 2003 to 1000 households in Victoria, Australia. Households had been randomly selected from the electoral role. A total of 415 respondents participated. Results indicated that higher socioeconomic status was related to better information about the recall event and more trust in manufacturers. Respondents who held traditional or naturalistic values were likely to trust that faults in the system would be regulated by the government or consumers themselves. Parents and older respondents were more likely to be critical of the Therapeutic Goods Administration which co-ordinated the recall. Parental status, education and values were related to subsequent changes in respondents' use of complementary medicines. In light of the worth of the health supplement industry to the Australian economy, the results of this survey suggest that the Therapeutic Goods Administration should adopt a more transparent and accountable role towards the public.

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Purpose Zinc sulfate is known to inhibit the bitterness of the antimalarial agent quinine [R. S. J. Keast. The effect of zinc on human taste perception. J. Food Sci. 68:1871–1877 (2003)]. In the present work, we investigated whether zinc sulfate would inhibit other bitter-tasting compounds and pharmaceuticals. The utility of zinc as a general bitterness inhibitor is compromised, however, by the fact that it is also a good sweetness inhibitor [R. S. J. Keast, T. Canty, and P. A. S. Breslin. Oral zinc sulfate solutions inhibit sweet taste perception. Chem. Senses 29:513–521 (2004)] and would interfere with the taste of complex formulations. Yet, zinc sulfate does not inhibit the sweetener Na-cyclamate. Thus, we determined whether a mixture of zinc sulfate and Na-cyclamate would be a particularly effective combination for bitterness inhibition (Zn) and masking (cyclamate).

Method We used human taste psychophysical procedures with chemical solutions to assess bitterness blocking.

Results Zinc sulfate significantly inhibited the bitterness of quinine–HCl, Tetralone, and denatonium benzoate (DB) (p < 0.05), but had no significant effect on the bitterness of sucrose octa-acetate, pseudoephedrine (PSE), and dextromethorphan. A second experiment examined the influence of zinc sulfate on bittersweet mixtures. The bitter compounds were DB and PSE, and the sweeteners were sucrose (inhibited by 25 mM zinc sulfate) and Na-cyclamate (not inhibited by zinc sulfate). The combination of zinc sulfate and Na-cyclamate most effectively inhibited DB bitterness (86%) (p < 0.0016), whereas the mixture's inhibition of PSE bitterness was not different from that of Na-cyclamate alone.

Conclusion A combination of Na-cyclamate and zinc sulfate was most effective at inhibiting bitterness. Thus, the combined use of peripheral oral and central cognitive bitterness reduction strategies should be particularly effective for improving the flavor profile of bitter-tasting foods and pharmaceutical formulations.

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A critical and comprehensive review of acidic potassium permanganate chemiluminescence is presented. This includes discussion on reaction conditions, the influence of enhancers such as polyphosphates, formaldehyde and sulfite, the relationship between analyte structure and chemiluminescence intensity, and the application of this chemistry to determine a wide variety of compounds, such as pharmaceuticals, biomolecules, antioxidants, illicit drugs, pesticides and pollutants. Previous proposals for the nature of the emitting species are re-evaluated in light of recent evidence.

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An Australian federal government committee recently proposed, as a cost-saving measure, the introduction of sealed-bid competitive tendering to exclusively supply the Pharmaceutical Benefits Scheme with specific generic medicines. A similar plan involved an open tender to supply generic products below a government set price, also linked with a reduced patient co-payment as an incentive. These proposals represented an opportunity to encourage the price of generic pharmaceuticals to move closer to the marginal cost of production—a process that could be subsequently applied to innovative (or brand-name) patented medicines in a therapeutic class with many competitors. This article examines these tendering proposals, particularly in relation to the potential for increased involvement of generic pharmaceutical manufacturers in the Australian market.

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The article presents survey commentaries and analysis on biotechnology international alliances and biotechnology boom in Singapore in 2010. The survey revealed that the government and other key government industries are not keen in investing money in areas such as agricultural biotechnology, vaccine production, natural medicine, alternative therapeutics and plant biotechnology which have economic future globally. Most stakeholders expect international alliances and biopartnering with Singapore. They identified that the industry's strengths are biomedical and pharmaceuticals.