Assessment of Pharmaceutical Equivalence: Difference Test or Equivalence Test?

Pharmaceutical equivalence is an important step towards the confirmation of similarity and Interchangeability among pharmaceutical products, particularly regarding those that win not be tested for bioequivalence. The aim of this paper is to compare traditional difference testing to two one-side equivalence tests in the assessment of pharmaceutical equivalence, by means of equivalence studies between similar, generic and reference products of acyclovir cream, atropine sulfate injection, meropenem for injection, and metronidazole injection. All tests were performed in accordance with the Brazilian Pharmacopeia or the United States Pharmacopeia. All four possible combinations of results arise in these comparisons of difference testing and equivalence testing. Most of the former did not show significant difference, whereas the latter presented similarity. We concluded that equivalence testing is more appropriate than difference testing, what can make it a useful tool to assess pharmaceutical equivalence in products that will not be tested for bioequivalence.

Re-examining "difference" and "development" : a note on broadening the field of gender and development in Japan

It is the author’s position that the framework for WID/GAD, as academic field and practice concerned primarily with developing countries should be broadened so as to incorporate Japan’s own gender and development issues in its scope. Unlike other developed countries, activists and scholars in Japan rarely connected, as was also the case with the fields of women’s/gender studies and WID/GAD. However, this was not due to any lack of interest among Japanese women regarding the lives of women in developing countries. Rather the points of fissure were the notions of ‘difference’ and ‘development’ held by Japanese women. These analytical concepts were narrowly defined, which resulted in limited interaction between discourse on women’s issues in Japan and WID/GAD related to ‘other’ women. By re-examining these notions and looking more deeply into perceived differences in the local context of ‘development’, not only can we strategize on ‘differences’ in such a way that we draw strength from the very fact of being different, but also prevent ‘differences’ from being used as grounds for discrimination. As a whole, we could gain substantially by broadening the field of Gender and Development and, as such, it is imperative that this field be broadened with urgency as development itself changes in this ever-interconnected world

Difference schemes for numerical solutions of lagging models of heat conduction

Non-Fourier models of heat conduction are increasingly being considered in the modeling of microscale heat transfer in engineering and biomedical heat transfer problems. The dual-phase-lagging model, incorporating time lags in the heat flux and the temperature gradient, and some of its particular cases and approximations, result in heat conduction modeling equations in the form of delayed or hyperbolic partial differential equations. In this work, the application of difference schemes for the numerical solution of lagging models of heat conduction is considered. Numerical schemes for some DPL approximations are developed, characterizing their properties of convergence and stability. Examples of numerical computations are included.

A knowledge based system of principled negotiation for complex business contract

Automated negotiation systems can do better than human being in many aspects, and thus are applied into many domains ranging from business to computer science. However, little work about automating negotiation of complex business contract has been done so far although it is a kind of the most important negotiation in business. In order to address this issue, in this paper we developed an automated system for this kind of negotiation. This system is based on the principled negotiation theory, which is the most effective method of negotiation in the domain of business. The system is developed as a knowledge-based one because a negotiating agent in business has to be economically intelligent and capable of making effective decisions based on business experiences and knowledge. Finally, the validity of the developed system is shown in a real negotiation scenario where on behalf of human users, the system successfully performed a negotiation of a complex business contract between a wholesaler and a retailer. © 2013 Springer-Verlag Berlin Heidelberg.

Decolonising the concept of knowledge

Controlling the definition of what was essentially a subjugated culture, the colonisers reserve the power to distinguish authentic aspects of the living traditions of the colonised. If the colonised argue political demands by reference to their culture, the colonisers are quick to adjudicate what is genuine in such claims. (Fannon, 1967) Since colonial invasions, Australia’s Indigenous people have weathered rapid change. While the origins of Australia’s Indigenous peoples continues to be an archaeological interest for many, how Indigenous cultures have survived, transformed and retained a sense of ‘difference’ is fundamental to understanding the diversity of Aboriginal and Torres Strait Islander cultures within this continent as both contemporaneous and historical. It is important that teachers, students and researchers within Indigenous studies remind themselves that much of the literature on Aboriginal and Torres Strait Islanders can be ideologically traced back to the emergence of ‘knowledge’ about native peoples in the context of European imperialism and expansion from the fifteenth century. Care must therefore be taken in not conveying ‘scientific’ rational knowledge as perhaps the hidden agenda or notion of assumptions of European ‘superiority’ and non-European inferiority. The recognition by the High Court of Australia (1992) abandoned the legal myth of terra nullius which based the dispossession of Indigenous land on the basis of it being considered an empty land. It could also be argued that this decision recognised that distinct customs and traditions continue to exist within the social and cultural ‘knowledge’ of Indigenous peoples of Australia. General issues and concerns relating to research design, methodology and articulation within QUT are not just confined to this university and the research project presented as a case study but are important in dealing with how Aboriginal and Torres Strait Islander students and academics participate or are employed within the university. We feel that the design and methodology of research that either covertly or overtly focuses on Indigenous Australians can no longer presume that all research will naturally follow protocols that are culturally appropriate as this appropriateness is usually defined by the institution. By no means do we feel that research should be debilitated as a result of raising these issues, but that collaborative approaches within the ‘process’ of research will address Aboriginal and Torres Strait Islander people and communities as much as the intended outcomes of research itself.

Modernity and the 'failure' of crime control

Rather than understanding the recurrent failure of various attempts at crime control as unfortunate and undesirable aberrations, all too familiar glitches an otherwise uninterrupted teleological march to a better society, such failures are instead positioned as part of the fabric of late modernity itself. That is, society changes not according to a predetermined logic along neatly defined and clearly reasoned tracks, rather it hurtles from crisis to crisis, from failure to failure, and it is the regulation of that failure which produces new initiatives and new forms of governance. Utilising the example of the modern prison, this chapter contends that too great an emphasis upon this institution’s ‘failure’ results not only in a neglect of the many other functions that it serves in the regulation of difference, but also, and more generally, it results in an underestimation of the importance of failure in providing new impetus for social transformation.

Pathologising difference, governing personality

Recent research has stressed the integral part played by teachers in both preliminary diagnosis and ongoing treatment of a range of conduct and personality disorders. Teachers are not only required to be aware of a variety of new categories of difference (Attention Deficit Disorder, Selective Mutism, Borderline Personality Disorder, Antisocial Personality Disorder, to name but a few), but are also now lauded for extending the role of education into new areas of social management. This paper will take issue with this understanding on two counts: first, teachers have always sought to mould the personalities of students, and the pathologisation of specific forms of conduct is simply a new tactic within a very old and familiar strategy. Second, schools do not simply discover disorders such as ADD as objective facts of nature. Rather, they are part of the process through which such differences are created, and by which individuals can be more effectively governed.

A regulatory analysis of international climate change regulation

The political challenges impeding the negotiation of a comprehensive multilateral agreement on international climate change have received a great deal of attention. A question that has gone somewhat overlooked is what essential components an effective regulatory scheme to reduce greenhouse gas emissions should contain. The objective of this article is to examine the regulatory architecture of current international arrangements relating to global climate change regulation. A systematic analysis of the structure, substantive composition, and administrative characteristics of the UNFCCC and Kyoto Protocol is undertaken. The analytical standard against which the agreements are examined is whether current international regulatory arrangements satisfy the basic requirements of regulatory coherence. The analysis identifies how the present scheme consists of a complex institutional structure that lacks a substantive regulatory core. The implications of the absence of functional and effective mechanisms to govern greenhouse gas emission reductions are considered in relation to the principles of good regulatory design. This, in turn, provides useful insights into how a better regulatory scheme might be designed.

The experience of China-educated nurses working in Australia : a symbolic interactionist perspective

Transnational nurse migration is a growing phenomenon. However, relatively little is known about the experiences of immigrant nurses and particularly about non-English speaking background nurses who work in more economically developed countries. Informed by a symbolic interactionist framework, this research explored the experience of China-educated nurses working in the Australian health care system. Using a modified constructivist grounded theory method, the main source of data were 46 face to face in-depth interviews with 28 China-educated nurses in two major cities in Australia. The key findings of this research are fourfold. First, the core category developed in this study is reconciling different realities, which inserts a theoretical understanding beyond the concepts of acculturation, assimilation, and integration. Second, in contrast to the dominant discourse which reduces the experience of immigrant nurses to language and culture, this research concludes that it was not just about language and nor was it simply about culture. Third, rather than focus on the negative aspects of difference as in the immigration literature and in the practice of nursing, this research points to the importance of recognising the social value of difference. Finally, the prevailing view that the experience of immigrant nurses is largely negative belies its complexities. This research concludes that it is naïve to define the experience as either good or bad. Rather, ambivalence was the essential feature of the experience and a more appropriate theoretical concept. This research produced a theoretical understanding of the experience of China-educated nurses working in Australia. The findings may not only inform Chinese nurses who wish to immigrate but also contribute to the implementation of more effective support services for immigrant nurses in Australian health care organisations.

Eat, drink and be civil

Brisbane is provincial city that has been developing rapidly since the early 1990s. The growth and development of its public and semi-public spaces means there are many more ways to engage with the city than was previously possible. --------- I suggest the city’s new and transformed spaces have enabled 2 important developments 1) a growth in forms of sociability and encounters with difference and 2) the negotiation of civic competencies. --------- The paper draws upon research conducted during a PhD project which used multi-method approaches - including qualitative [interviews] and quantitative data [surveys], psychoanalytic theory and text analysis.The study also made connections between the real city and the discursive city to argue that urban experience is constituted both materially and imaginatively.

A naturalistic inquiry of registered nurses' perspectives and expectations of psychodynamic therapeutic care in acute psychiatric inpatient facilities

Within contemporary inpatient mental health nursing practice, the psychodynamic model of care considered previously to be central to the nurse-patient relationship now seems a radical concept. It appears to exist only within primary care facilities and public health care practice settings. This naturalistic inquiry aimed to explicate mental health nurses' perspectives and expectations of providing psychodynamic therapeutic care in acute inpatient psychiatric facilities. Ten registered nurses working in acute inpatient mental health facilities were interviewed. Five themes emerged: a career for life, relating in a psychodynamic manner, swimming against the current, adopting a position of difference, and hopeful expectancy.

Merging fact with fiction : a study of year 9 students' developing scientific literacy through the writing of hybridised scientific narratives on a socioscientific issue

International assessments of student science achievement, and growing evidence of students' waning interest in school science, have ensured that the development of scientific literacy continues to remain an important educational priority. Furthermore, researchers have called for teaching and learning strategies to engage students in the learning of science, particularly in the middle years of schooling. This study extends previous national and international research that has established a link between writing and learning science. Specifically, it investigates the learning experiences of eight intact Year 9 science classes as they engage in the writing of short stories that merge scientific and narrative genres (i.e., hybridised scientific narratives) about the socioscientific issue of biosecurity. This study employed a triangulation mixed methods research design, generating both quantitative and qualitative data, in order to investigate three research questions that examined the extent to which the students' participation in the study enhanced their scientific literacy; the extent to which the students demonstrated conceptual understanding of related scientific concepts through their written artefacts and in interviews about the artefacts; and the extent to which the students' participation in the project influenced their attitudes toward science and science learning. Three aspects of scientific literacy were investigated in this study: conceptual science understandings (a derived sense of scientific literacy), the students' transformation of scientific information in written stories about biosecurity (simple and expanded fundamental senses of scientific literacy), and attitudes toward science and science learning. The stories written by students in a selected case study class (N=26) were analysed quantitatively using a series of specifically-designed matrices that produce numerical scores that reflect students' developing fundamental and derived senses of scientific literacy. All students (N=152) also completed a Likert-style instrument (i.e., BioQuiz), pretest and posttest, that examined their interest in learning science, science self-efficacy, their perceived personal and general value of science, their familiarity with biosecurity issues, and their attitudes toward biosecurity. Socioscientific issues (SSI) education served as a theoretical framework for this study. It sought to investigate an alternative discourse with which students can engage in the context of SSI education, and the role of positive attitudes in engaging students in the negotiation of socioscientific issues. Results of the study have revealed that writing BioStories enhanced selected aspects of the participants' attitudes toward science and science learning, and their awareness and conceptual understanding of issues relating to biosecurity. Furthermore, the students' written artefacts alone did not provide an accurate representation of the level of their conceptual science understandings. An examination of these artefacts in combination with interviews about the students' written work provided a more comprehensive assessment of their developing scientific literacy. These findings support extensive calls for the utilisation of diversified writing-to-learn strategies in the science classroom, and therefore make a significant contribution to the writing-to-learn science literature, particularly in relation to the use of hybridised scientific genres. At the same time, this study presents the argument that the writing of hybridised scientific narratives such as BioStories can be used to complement the types of written discourse with which students engage in the negotiation of socioscientific issues, namely, argumentation, as the development of positive attitudes toward science and science learning can encourage students' participation in the discourse of science. The implications of this study for curricular design and implementation, and for further research, are also discussed.

Evaluating the effect of a patient education brochure on patients’ expectations and satisfaction with emergency department service

Introduction: The purpose of this study was to assess the capacity of a written intervention, in this case a patient information brochure, to improve patient satisfaction during an Emergency Department (ED) visit. For the purpose of measuring the effect of the intervention the ED journey was conceptualised as a series of distinct areas of service comprising waiting time, service by the triage nurse, care from doctors and nurses and information giving Background of study: Research into patient satisfaction has become a widespread activity endorsed by both governments and hospital administrations. The literature on ED patient satisfaction has consistently indicated three primary areas of patient dissatisfaction: waiting time, nursing care and communication. Recent developments in the literature on patient satisfaction studies however have highlighted the relationship between patients. expectations of a service encounter and their consequent assessment of the experience as dissatisfying or satisfying. Disconfirmation theory posits that the degree to which expectations are confirmed will affect subsequent levels of satisfaction. The conceptual framework utilised in this study is Coye.s (2004) model of disconfirmation. Coye while reiterating satisfaction is a consequence of the degree expectations are either confirmed or disconfirmed also posits that expectations can be modified by interventions. Coye.s work conceptualises these interventions as intra encounter experiences (cues) which function to adjust expectations. Coye suggests some cues are unintended and may have a negative impact which also reinforces the value of planned cues intended to meet or exceed consumer expectations. Consequently the brochure can be characterized as a potentially positive cue, encouraging the patient to understand processes and to orient them in what can be a confronting environment. Only a limited number of studies have examined the effect of written interventions within an ED. No studies could be located which have tested the effect of ED interventions using a conceptual framework which relates the effect of the degree to which expectations are confirmed or disconfirmed in terms of satisfaction with services. Method: Two studies were conducted. Study One used qualitative methods to explore patients. expectations of the ED from the perspective of both patients and health care professionals. Study One was used in part to direct the development of the intervention (brochure) in Study Two. The brochure was an intervention designed to modify patients. expectations thus increasing their satisfaction with the provision of ED service. As there was no existing tools to measure ED patients. expectations and satisfaction a new tool was also developed based on the findings and the literature of Study One. Study Two used a non-randomised, quasi-experimental approach using a non-equivalent post-test only comparison group design used to investigate the effect of the patient education brochure (Stommel and Wills, 2004). The brochure was disseminated to one of two study groups (the intervention group). The effect of the brochure was assessed by comparing the data obtained from both the intervention and control group. These two groups consisted of 150 participants each. It was expected that any differences in the relevant domains selected for examination would indicate the effect of the brochure both on expectation and potentially satisfaction. Results: Study One revealed several areas of common ground between patients and nurses in terms of relevant content for the written intervention, including the need for information on the triage system and waiting times. Areas of difference were also found with patients emphasizing communication issues, whereas focus group members expressed concern that patients were often unable to assimilate verbal information. The findings suggested the potential utility of written material to reinforce verbal communication particularly in terms of the triage process and other ED protocols. This material was synthesized within the final version of the written intervention. Overall the results of Study Two indicated no significant differences between the two groups. The intervention group did indicate a significant number of participants who viewed the brochure of having changed their expectations. The effect of the brochure may have been obscured by a lack of parity between the two groups as the control group presented with statistically significantly higher levels of acuity and experienced significantly shorter waiting times. In terms of disconfirmation theory this would suggest expectations that had been met or exceeded. The results confirmed the correlation of expectations with satisfaction. Several domains also indicated age as a significant predictor with older patients tending to score higher satisfaction results. Other significant predictors of satisfaction established were waiting time and care from nurses, reinforcing the combination of efficient service and positive interpersonal experiences as being valued by patients. Conclusions: Information presented in written form appears to benefit a significant number of ED users in terms of orientation and explaining systems and procedures. The degree to which these effects may interact with other dimensions of satisfaction however is likely to be limited. Waiting time and interpersonal behaviours from staff also provide influential cues in determining satisfaction. Written material is likely to be one element in a series of coordinated strategies to improve patient satisfaction during periods of peak demand.

Developing shared understandings of standards-based assessment : online moderation practices across geographically diverse contexts

This thesis investigates the place of online moderation in supporting teachers to work in a system of standards-based assessment. The participants of the study were fifty middle school teachers who met online with the aim of developing consistency in their judgement decisions. Data were gathered through observation of the online meetings, interviews, surveys and the collection of artefacts. The data were viewed and analysed through sociocultural theories of learning and sociocultural theories of technology, and demonstrates how utilising these theories can add depth to understanding the added complexity of developing shared meaning of standards in an online context. The findings contribute to current understanding of standards-based assessment by examining the social moderation process as it acts to increase the reliability of judgements that are made within a standards framework. Specifically, the study investigates the opportunities afforded by conducting social moderation practices in a synchronous online context. The study explicates how the technology affects the negotiation of judgements and the development of shared meanings of assessment standards, while demonstrating how involvement in online moderation discussions can support teachers to become and belong within a practice of standards-based assessment. This research responds to a growing international interest in standards-based assessment and the use of social moderation to develop consistency in judgement decisions. Online moderation is a new practice to address these concerns on a systemic basis.

Connecting Diversity : Paradoxes of Multicultural Australia

Commissioned by SBS, and published in March 2006, Connecting Diversity: Paradoxes of Multicultural Australia is a follow-up study to SBS’s 2002 report, Living Diversity: Australia’s Multicultural Future. The attitudes of many younger Australians from culturally diverse backgrounds reveal paradoxes about Australian multiculturalism today. This report sheds light on their views, experiences and expectations and the role of media in their lives. Younger, culturally and linguistically diverse Australians are often the subject of mediafanned controversy about disaffection, ‘ethnic gangs’ and cultural isolation. While these controversies tend to be localised – Cronulla, Inala or Bankstown – Connecting Diversity tells a national and quite different story. This research builds upon the findings of the 2002 report, Living Diversity: Australia’s Multicultural Future, which challenged common assumptions about contemporary multicultural Australia. In an era of fragmenting media and assumed political apathy, Connecting Diversity further examines many of the findings of the earlier study, with a new focus on younger people, cultural identity and media use. Connecting Diversity reveals individual experiences and often contradictory ideas about media and diversity in Australia. Disjunctions appear to exist between an individual’s experience and their thoughts about Australia’s national identity. Multiculturalism is valued for broadening the appreciation of difference, yet this support can coexist with concerns about perceived segregation, usually ‘elsewhere’ in Australia. Younger people tend to be more comfortable with cultural difference than previous generations and cite their own diverse network of friends as one of the reasons for this. Even so, some describe experiences of racism that engender a feeling of exclusion from ‘mainstream’ society. In their everyday lives, social relationships are navigated through regular and familiar connections on the one hand, and experiences and expressions of disconnection on the other. Racism and tolerance may be expressed almost simultaneously. These disconnections are often managed through ‘practical tolerance',allowing them to negotiate these apparent contradictions. The connections can be based simultaneously on such things as work, family,religion, friendships or location. The result is a multilayered sense of personal belonging and community connection. A large number of respondents in these focus groups expressed frustration at the failings of media, especially news and current affairs coverage, yet spoke enthusiastically about the accessibility and range of media compared to what was available to previous generations. In their many forms, media remain a key ingredient of self-identification among younger Australians of culturally diverse backgrounds who are especially cynical about media and disillusioned by their perceived inability to influence issues that are important to them. These findings reveal that although they may be cynical about media messages, these younger Australians are looking for connection through media and are seeking ways to participate in meaningful ways. This raises questions about the possibilities for media to empower younger people to play a part in genuine cultural democracy. By capturing the attitudes of Australians of culturally diverse backgrounds under the age of 40, Connecting Diversity: Paradoxes of Multicultural Australia provides an insight into social trends and the generational and cultural changes that are now shaping Australia.