A QUM partnership approach to regulating biosimilars in Australia

Despite the realisation of the potential implications from biosimilars is relatively recent, much has already been written about raising the awareness of differences between biosimilars and originating/ reference listed (innovator) pharmaceuticals. The European Medicines Agency has led the global charge in regulating biosimilars. Regardless of sufficient similarities across international regulations, differences do exist across jurisdictions. The consideration of regulating biosimilars demands a congruent approach across all stages: pre-registration (Australian copyright protection, patent, international obligations), registration (confidential information, international regulators, safety and efficacy), post-registration (Pharmaceutical Benefit Scheme, prescriber and dispenser awareness). Our National Medicines Policy could provide the necessary congruent framework and function for national and international regulation of biosimilars. The Policy concedes that pharmaceuticals will be affected by financial policies and trade considerations, international treaty obligations, industrial policies, education policies and the need for public-private partnerships.

Fire resistance rating of light gauge steel frame walls exposed to realistic design fires : a review and development of time equivalent approach

This paper presents the details of research undertaken on the development of an energy based time equivalent approach for light gauge steel frame (LSF) walls. This research utilized an energy based time equivalent approach to obtain the fire resistance ratings (FRR) of LSF walls exposed to realistic design fires with respect to standard fire exposure [1]. It is based on the equal area concept of fire severity and relates to the amount of energy transferred to the member. The proposed method was used to predict the fire resistance of single and double plasterboard lined and externally insulated LSF walls. The predicted fire resistance ratings were compared with the results from finite element analyses and fire design rules for three different wall configurations. This paper presents the review of the available time equivalent approaches and the development of energy based time equivalent approach for the prediction of fire resistance ratings of LSF walls exposed to realistic design fires.

Effect of elemental composition and size on electron confinement in self-assembled SiC quantum dots : a combinatorial approach

A high level of control over quantum dot (QD) properties such as size and composition during fabrication is required to precisely tune the eventual electronic properties of the QD. Nanoscale synthesis efforts and theoretical studies of electronic properties are traditionally treated quite separately. In this paper, a combinatorial approach has been taken to relate the process synthesis parameters and the electron confinement properties of the QDs. First, hybrid numerical calculations with different influx parameters for Si1-x Cx QDs were carried out to simulate the changes in carbon content x and size. Second, the ionization energy theory was applied to understand the electronic properties of Si1-x Cx QDs. Third, stoichiometric (x=0.5) silicon carbide QDs were grown by means of inductively coupled plasma-assisted rf magnetron sputtering. Finally, the effect of QD size and elemental composition were then incorporated in the ionization energy theory to explain the evolution of the Si1-x Cx photoluminescence spectra. These results are important for the development of deterministic synthesis approaches of self-assembled nanoscale quantum confinement structures.

Electron transport across magnetic field in low-temperature plasmas : an alternative approach for obtaining evidence of Bohm mechanism

A comparative study involving both experimental and numerical investigations was made to resolve a long-standing problem of understanding electron conductivity mechanism across magnetic field in low-temperature plasmas. We have calculated the plasma parameters from experimentally obtained electric field distribution, and then made a 'back' comparison with the distributions of electron energy and plasma density obtained in the experiment. This approach significantly reduces an influence of the assumption about particular phenomenology of the electron conductivity in plasma. The results of the experiment and calculations made by this technique have showed that the classical conductivity is not capable of providing realistic total current and electron energy, whereas the phenomenological anomalous Bohm mobility has demonstrated a very good agreement with the experiment. These results provide an evidence in favor of the Bohm conductivity, thus making it possible to clarify this pressing long-living question about the main driving mechanism responsible for the electron transport in low-temperature plasmas.

The phenomenological approach : a framework to design markets

An approach is proposed and applied to five industries to prove how phenomenology can be valuable in rethinking consumer markets (Popp & Holt, 2013). The purpose of this essay is to highlight the potential implications that 'phenomenological thinking' brings for competitiveness and innovation (Sanders, 1982), hence helping managers being more innovative in their strategic marketing decisions (i.e. market creation, positioning, branding). Phenomenology is in fact a way of thinking − besides and before being a qualitative research procedure − a very practical exercise that strategic managers can master and apply in the same successful way as other scientists have already done in their fields of study (e.g. sociology, psychology, psychiatry, and anthropology). Two fundamental considerations justify this research: a lack of distinctiveness among firms due to high levels of competition and consumers no longer knowing what they want (i.e. no more needs). The authors will show how the classical mental framework generally used to study markets by practitioners appears on the one hand to be established and systematic in the life of a company, while on the other is no longer adequate to meet the needs of innovation required to survive. To the classic principles of objectivity, generality, and psycho-sociology the authors counterpose the imaginary, eidetic-phenomenological reduction, and an existential perspective. From a theoretical point of view, this paper introduces a set of functioning rules applicable to achieve innovation in any market and useful to identify cultural practices inherent in the act of consumption.

Nonlinear geometric and material computational technique : higher-order element with refined plastic hinge approach

This paper addresses of the advanced computational technique of steel structures for both simulation capacities simultaneously; specifically, they are the higher-order element formulation with element load effect (geometric nonlinearities) as well as the refined plastic hinge method (material nonlinearities). This advanced computational technique can capture the real behaviour of a whole second-order inelastic structure, which in turn ensures the structural safety and adequacy of the structure. Therefore, the emphasis of this paper is to advocate that the advanced computational technique can replace the traditional empirical design approach. In the meantime, the practitioner should be educated how to make use of the advanced computational technique on the second-order inelastic design of a structure, as this approach is the future structural engineering design. It means the future engineer should understand the computational technique clearly; realize the behaviour of a structure with respect to the numerical analysis thoroughly; justify the numerical result correctly; especially the fool-proof ultimate finite element is yet to come, of which is competent in modelling behaviour, user-friendly in numerical modelling and versatile for all structural forms and various materials. Hence the high-quality engineer is required, who can confidently manipulate the advanced computational technique for the design of a complex structure but not vice versa.

The Hofstedian approach : suggestions for a conceptual development of comparative journalism studies

In recent years there has been a burgeoning amount of research comparing journalistic practices in a wide range of countries around the world. Much of this literature has tended to focus on identifying what the similarities and differences between these different journalistic cultures are. Most importantly, research has focused on answering the question of whether, particularly in the age of globalisation, ‘a journalistic culture’ may exist. While there has been some evidence that there may indeed be a convergence of journalistic cultures, studies have at the same time found that important differences still persist. However, most of the literature has so far still tended to concentrate purely on the differences and similarities, without examining in detail why these exist. In this context, the author argues that employing a cross-cultural approach rooted in anthropology can at least partially trace the development of particularly the differences by linking them to the wider concept of cultural differences between countries. Specifically the paper here evaluates the usefulness of applying the value systems appraoch, as designed by Dutch anthropologist Geert Hofstede, to journalism research. By examining some of the few studies that have employed Hofstede’s approach, the paper argues that value systems can provide a classification on a conceptual level for investigating how journalism is practiced around the world. In the light of complaints in the Asia-Pacific region that the imported Western models of journalism are not in line with cultural values, this approach can also provide some basis from which to develop future approaches to journalism education.

Plasma-aided nanofabrication: "plasma-building block" approach

Unique features and benefits of the plasma-aided nanofabrication are considered by using the "plasma-building block" approach, which is based on plasma diagnostics and nanofilm characterization, cross-referenced by numerical simulation of generation and dynamics of building blocks in the gas phase, their interaction with nanostructured surfaces, and ab initio simulation of chemical structure of relevant nanoassemblies. The examples include carbon nanotip microemitter structures, semiconductor quantum dots and nanowires synthesized in the integrated plasma-aided nanofabrication facility.

Nanofabrication of single-crystalline flat-panel display microemitters : a plasma-building unit approach

This contribution is focused on plasma-enhanced chemical vapor deposition systems and their unique features that make them particularly attractive for nanofabrication of flat panel display microemitter arrays based on ordered patterns of single-crystalline carbon nanotip structures. The fundamentals of the plasma-based nanofabrication of carbon nanotips and some other important nanofilms and nanostructures are examined. Specific features, challenges, and potential benefits of using the plasma-based systems for relevant nanofabrication processes are analyzed within the framework of the "plasma-building unit" approach that builds up on extensive experimental data on plasma diagnostics and nanofilm/nanostructure characterization, and numerical simulation of the species composition in the ionized gas phase (multicomponent fluid models), ion dynamics and interaction with ordered carbon nanotip patterns, and ab initio computations of chemical structure of single crystalline carbon nanotips. This generic approach is also applicable for nanoscale assembly of various carbon nanostructures, semiconductor quantum dot structures, and nano-crystalline bioceramics. Special attention is paid to most efficient control strategies of the main plasma-generated building units both in the ionized gas phase and on nanostructured deposition surfaces. The issues of tailoring the reactive plasma environments and development of versatile plasma nanofabrication facilities are also discussed.

Reducing building information fragmentation : a BIM-specifications approach

The world of Construction is changing, so too are the expectations of stakeholders regarding strategies for adapting existing resources (people, equipment and finances), processes and tools to the evolving needs of the industry. Building Information Modelling (BIM) is a data-rich, digital approach for representing building information required for design and construction. BIM tools play a crucial role and are instrumental to current approaches, by industry stakeholders, aimed at harnessing the power of a single information repository for improved project delivery and maintenance. Yet, building specifications - which document information on material quality, and workmanship requirements - remain distinctly separate from model information typically represented in BIM models. BIM adoption for building design, construction and maintenance is an industry-wide strategy aimed at addressing such concerns about information fragmentation. However, to effectively reduce inefficiencies due to fragmentation, BIM models require crucial building information contained in specifications. This paper profiles some specification tools which have been used in industry as a means of bridging the BIM-Specifications divide. We analyse the distinction between current attempts at integrating BIM and specifications and our approach which utilizes rich specification information embedded within objects in a product library as a method for improving the quality of information contained in BIM objects at various levels of model development.

Enriching the "I" in Bim : a BIM-Specifications (Bimspecs) approach

This paper conceptualizes a framework for bridging the BIM-Specifications divide by embedding project-specific information in BIM objects by means of a product library. We demonstrate how model information, enriched with data at various levels of development (LODs), can evolve simultaneously with design and construction using a window object embedded in a wall as life-cycle phase exemplars at different levels of granularity. The conceptual approach is informed by the need for exploring an approach that takes cognizance of the limitations of current modelling tools in enhancing the information content of BIM models. Therefore, this work attempts to answer the question, “How can the modelling of building information be enhanced throughout the life-cycle phases of buildings utilizing building specification information?”

Understanding the value of social media in organisations : a taxonomic approach

While organizations strive to leverage the vast information generated daily from social media platforms and both decision makers and consultants are keen to identify and exploit this information’s value, there has been little research into social media in the business context. Social media are diverse, varying in scope and functionality, this diversity entailing a complex of attributes and characteristics, resulting in confusion for both researchers and organizations. Taxonomies are important precursors in emerging fields and are foundational for rigorous theory building. Though aspects of social media have been studied from various discipline perspectives, this work has been largely descriptive. Thus, while the need for a rigorous taxonomy of social media is strong, previous efforts to classify social media suffer limitations – e.g. lack of a systematic taxonomic method, overreliance on intuition, disregard for the users’ perspective, and inadequate consideration of purpose. Thus, this study was mainly initiated by the overarching question “How can social media in the business context be usefully classified?” In order to address this gap, the current paper proposes a systematic method for developing a taxonomy appropriate to study social media in organizations context, combining Nickerson et al,’s (2012) IS taxonomy building guidelines and a Repertory grid (RepGrid) approach.

Development and pilot study of the Primary Care Practice Improvement Tool (PC-PIT) : an innovative approach

Objective To assess the usability and validity of the Primary Care Practice Improvement Tool (PC-PIT), a practice performance improvement tool based on 13 key elements identified by a systematic review. It was co-created with a range of partners and designed specifically for primary health care. Design This pilot study examined the PC-PIT using a formative assessment framework and mixed-methods research design. Setting and participants Six high-functioning general practices in Queensland, Australia, between February and July 2013. A total of 28 staff participated — 10 general practitioners, six practice or community nurses, 12 administrators (four practice managers; one business manager and eight reception or general administrative staff). Main outcome measures Readability, content validity and staff perceptions of the PC-PIT. Results The PC-PIT offers an appropriate and acceptable approach to internal quality improvement in general practice. Quantitative assessment scores and qualitative data from all staff identified two areas in which the PC-PIT required modification: a reduction in the indicative reading age, and simplification of governance-related terms and concepts. Conclusion The PC-PIT provides an innovative approach to address the complexity of organisational improvement in general practice and primary health care. This initial validation will be used to develop a suite of supporting, high-quality and free-to-access resources to enhance the use of the PC-PIT in general practice. Based on these findings, a national trial is now underway.

A novel approach for numerical simulation of plant tissue shrinkage during drying

Drying is a key processing techniques used in food engineering which demands continual developments on advanced analysis techniques in order to optimize the product and the process. In this regard, plant based materials are a frequent subject of interest where microstructural studies can provide a clearer understanding on the fundamental physical mechanisms involved. In this context, considering numerous challenges of using conventional numerical grid-based modelling techniques, a meshfree particle based model was developed to simulate extreme deformations of plant microstructure during drying. The proposed technique is based on a particle based meshfree method: Smoothed Particle Hydrodynamics (SPH) and a Discrete Element Method (DEM). A tissue model was developed by aggrading individual cells modelled with SPH-DEM coupled approach by initializing the cells as hexagons and aggregating them to form a tissue. The model also involves a middle lamella resembling real tissues. Using the model, different dried tissue states were simulated with different moisture content, the turgor pressure, and cell wall contraction effects. Compared to the state of the art grid-based microscale plant tissue drying models, the proposed model is capable of simulating plant tissues at lower moisture contents which results in excessive shrinkage and cell wall wrinkling. Model predictions were compared with experimental findings and a fairly good agreement was observed both qualitatively and quantitatively.

Reconceptualizing digital service quality : a call-to-action and research approach

The nature of services and service delivery has been changing rapidly since the 1980’s when many seminal papers in services research were published. Services are increasingly digital, or have a digital component. Further, a large and heterogeneous literature, with competing and overlapping definitions, many of which are dated and inappropriate to contemporary digital services offerings is impeding progress in digital services research. In this conceptual paper, we offer a critical review of some existing conceptualizations of services and digital services. We argue that an inductive approach to understanding cognition about digital services is required to develop a taxonomy of digital services and a new vocabulary. We argue that this is a pre-requisite to theorizing about digital services, including understanding quality drivers, value propositions, and quality determinants for different digital service types. We propose a research approach for reconceptualising digital services and service quality, and outline methodological approaches and outcomes.