Challenges and emerging solutions in the development of compressed orally disintegrating tablets

Areas covered: The review discusses the main challenges of ODT manufacturing process and the emerging solutions featured at early drug development stages. The research specifically describes the methods reported for taste masking/assessment and solubilisation of unpalatable and poorly soluble drugs, respectively. Furthermore, this review highlights the techniques used for developing modified-release ODTs, an emerging area in the field. In addition, it also discusses the poor flowability and segregation problems of directly compressed powders. Moreover, the review describes the tests reported in the literature for ODT disintegration time assessment since a universal technique is still non-existent. Expert opinion: The approaches used to overcome the manufacturing challenges often have a bearing on the price of the end product. However, despite the technical and regulatory challenges, ODTs can offer many advantages over the conventional dosage forms if accompanied by suitable adjuvant technologies and in vitro analytical tools. © 2014 Informa UK, Ltd. Introduction: Orally disintegrating tablets (ODTs) provide several advantages over conventional tablets such as suitability for patients with swallowing difficulties and faster onset of action. The manufacture of ODTs by compression/tableting offers a practical and cost-effective strategy over the freeze drying (lyophilisation) method. Nonetheless, the FDA recommends a disintegration time of 30 s and a maximum weight of 500 mg for a tablet to be labelled as an ODT. These requirements, alongside other desirable product properties, have created a number of challenges for the formulator to overcome while developing compressed ODTs.

Innovativeness of Indian firms - catalysts and deterrents

Innovation is the driving force that is crucial for firms to sustain their competitive advantage and for economies and industries in general to surge forward. In comparison to developing economies, developed economies have always maintained greater focus on national innovation systems while the firms from these economies have been investing considerable effort on promoting organisational innovation. As firms became increasingly global, consumers across the world, especially from the emerging economies, are getting a taste of more sophisticated products and services. There was also an infusion of knowledge pertaining to cutting-edge technologies, innovation, processes and management systems into this part of the world. However, studies on organisational innovation have largely been confined to firms from developed economies in order to understand the effects of its determinants (Anderson et al., 2004; Choi and Williams, 2014; Li et al., 2013). Given the differences in the socio-cultural milieu between the developed and emerging economies, more nuanced understanding of the factors affecting and the processes associated with innovation in emerging markets is required.

Climate change impacts on migration and labour market

Floods, droughts and monsoons have always disturbed human settlements, but there are more settlements now and more people in the world. Therefore, if a natural disaster happens, more will suffer than ever before. Moreover, climate in the past several decades has been greatly degraded by anthropogenic activity. In some cases, the chain of causality of human influence on the climate is direct and unambiguous (e.g. the effects of irrigation on local humidity), though there are instances where it is less clear. Presently, the scientific consensus (IPCC, 2007) on climate change is that human activity is very likely the cause for the rapid increase of global average temperatures, more generally known as global warming.

A distance education case study: A comparison of instructional delivery methods practiced by higher education faculty and emerging standards

The purpose of this research was to compare the delivery methods as practiced by higher education faculty teaching distance courses with recommended or emerging standard instructional delivery methods for distance education. Previous research shows that traditional-type instructional strategies have been used in distance education and that there has been no training to distance teach. Secondary data, however, appear to suggest emerging practices which could be pooled toward the development of standards. This is a qualitative study based on the constant comparative analysis approach of grounded theory.^ Participants (N = 5) of this study were full-time faculty teaching distance education courses. The observation method used was unobtrusive content analysis of videotaped instruction. Triangulation of data was accomplished through one-on-one in-depth interviews and from literature review. Due to the addition of non-media content being analyzed, a special time-sampling technique was designed by the researcher--influenced by content analyst theories of media-related data--to sample portions of the videotape instruction that were observed and counted. A standardized interview guide was used to collect data from in-depth interviews. Coding was done based on categories drawn from review of literature, and from Cranton and Weston's (1989) typology of instructional strategies. The data were observed, counted, tabulated, analyzed, and interpreted solely by the researcher. It should be noted however, that systematic and rigorous data collection and analysis led to credible data.^ The findings of this study supported the proposition that there are no standard instructional practices for distance teaching. Further, the findings revealed that of the emerging practices suggested by proponents and by faculty who teach distance education courses, few were practiced even minimally. A noted example was the use of lecture and questioning. Questioning, as a teaching tool was used a great deal, with students at the originating site but not with distance students. Lectures were given, but were mostly conducted in traditional fashion--long in duration and with no interactive component.^ It can be concluded from the findings that while there are no standard practices for instructional delivery for distance education, there appears to be sufficient information from secondary and empirical data to initiate some standard instructional practices. Therefore, grounded in this research data is the theory that the way to arrive at some instructional delivery standards for televised distance education is a pooling of the tacitly agreed-upon emerging practices by proponents and practicing instructors. Implicit in this theory is a need for experimental research so that these emerging practices can be tested, tried, and proven, ultimately resulting in formal standards for instructional delivery in television education. ^

Differentiation of self and emerging adulthood

Today's young people are progressing from adolescence into adulthood differently than past generations, including taking a longer time to make this transition. Some believe that the developmental markers and tasks of this transitional period are unique enough to merit the designation of a new life stage--"emerging adulthood." Recently, this new life stage of emerging adulthood has received increasing attention in the developmental literature, including attention to the probable causes for its evolution. However, little is known about specific aspects of intra- and interpersonal development that occur during emerging adulthood. The purpose of this study was to empirically assess hypothesized relations between variables associated with the psychological constructs of attachment, psychosocial maturity, and differentiation of self, in a sample of emerging adults. Structural equation modeling (SEM) analyses indicated an association between the variables measuring these constructs (anxiety, avoidance, I-position, reactivity, cutoff, fusion, identity, and intimacy). The results from structural equation modeling (SEM) analyses helped to confirmed and extended previous research by demonstrating significant associations between attachment, psychosocial maturity, and differentiation of self through the variables operationalizing these constructs. Psychosocial maturity predicted differentiation of self (with intimacy predicting emotional cutoff and identity predicting cutoff and I-position). Attachment also predicted differentiation of self (with anxiety predicting all differentiation variables, and avoidance predicting emotional reactivity and cutoff). However, associations between anxiety and cutoff and between avoidance and cutoff were mediated by psychosocial identity and intimacy, and associations between anxiety and I-position were mediated by identity. Thus, these results corroborate and elaborate previous research conducted on these constructs. Specifically, relational tendencies thought to be influenced by attachment security impact interpersonal functioning in emerging adulthood, but this association is influenced by the degree of resolution of key psychosocial tasks.

Shareholder ratification of the auditor and audit market competition

In my dissertation, I examine factors associated with firms’ submission of auditor selection for shareholder ratification and test if shareholder ratification of auditor selection is associated with the extent of price competition in the audit market (as measured by audit fees) and audit quality (as measured by clients’ earnings management). The dissertation is motivated from the recent recommendation of the U.S. Treasury’s Advisory Committee on Auditing Profession (ACAP) regarding the submission of auditor selection for shareholder ratification votes. The ACAP suggests that this practice may improve the competition in the audit market; yet, there is no empirical evidence supporting the ACAP’s recommendation. My dissertation attempts to fill the gap in the literature on an issue of current interest to the auditing profession. I find that firm size, CEO-Chair duality, insider ownership and institutional ownership are associated with the submission of auditor selection for shareholder ratification vote. However, I do not find an association between audit committee variables and the submission of auditor selection for shareholder ratification vote. The second essay investigates the association between auditor ratification and audit fees. Audit fees are higher in firms that submit auditor selection for shareholder ratification. The finding is not consistent with the increased price competition predicted by the ACAP. The third essay of my dissertation examine whether the submission of auditor selection for shareholder ratification is associated with earnings management. I find that firms that submit auditor selection for shareholder ratification are more likely to have lower level of earnings management. Overall, the results suggest that the same factors that are associated with higher quality monitoring also may be associated with the submission of auditor selection for shareholder ratification vote. The results call into question the one-size-fits-all approach recommended by the ACAP.

Florida Bay: Water quality status and trends, historic and emerging algal bloom problems

Florida Bay is a unique subtropical estuary that while historically oligotrophic, has been subjected to both natural and anthropogenic stressors, including hurricanes, coastal eutrophication and other impacts. These stressors have resulted in degradation of water quality in the past several decades, most evidenced by reoccurring blooms of the picocyanobacterium Synechococcus spp. Major nutrient inputs consist of freshwater flows to the eastern region from runoff and regulated canal releases, inputs from the Everglades to the central region via Taylor Slough, exchanges with the Gulf of Mexico, which include intermittent Shark River inputs to the western region, stormwater and wastewater from the Florida Keys, and atmospheric deposition. These nutrient inputs have resulted in a transition from strong phosphorus (P) limitation of phytoplankton in the eastern bay to nitrogen (N) limitation in the western bay. Large blooms of Synechococcus were most pronounced in the central bay region, in the area of transition between P and N limitation, in the mid-1990s. Although non-toxic, these blooms, which have continued intermittently through the early 2000s, resulted in significant sea-grass and benthic organism mortalities. A new suite of stressors in 2005, including the passages of Hurricanes Katrina, Rita, and Wilma, additional canal releases, and the initiation of road construction to widen the main roadway leading to the Keys, were correlated with a large Synechococcus bloom in the previously clear, strongly P- limited, northeastern region of the bay. Sustained for 3 years, this bloom was accompanied by a shift from P limitation to N limitation during its course. Nutrient bioassay experiments suggest that this bloom persisted due to the ability of Synechococcus to access organic N and P sources, microbial and geochemical cycling of organic and inorganic nutrients in the water column and between the water column and sediments (both suspended particles and benthos), and decreased grazing by benthic fauna due to their die-off.

Shareholder Ratification of The Auditor and Audit Market Competition

In my dissertation, I examine factors associated with firms’ submission of auditor selection for shareholder ratification and test if shareholder ratification of auditor selection is associated with the extent of price competition in the audit market (as measured by audit fees) and audit quality (as measured by clients’ earnings management). The dissertation is motivated from the recent recommendation of the U.S. Treasury’s Advisory Committee on Auditing Profession (ACAP) regarding the submission of auditor selection for shareholder ratification votes. The ACAP suggests that this practice may improve the competition in the audit market; yet, there is no empirical evidence supporting the ACAP’s recommendation. My dissertation attempts to fill the gap in the literature on an issue of current interest to the auditing profession. I find that firm size, CEO-Chair duality, insider ownership and institutional ownership are associated with the submission of auditor selection for shareholder ratification vote. However, I do not find an association between audit committee variables and the submission of auditor selection for shareholder ratification vote. The second essay investigates the association between auditor ratification and audit fees. Audit fees are higher in firms that submit auditor selection for shareholder ratification. The finding is not consistent with the increased price competition predicted by the ACAP. The third essay of my dissertation examine whether the submission of auditor selection for shareholder ratification is associated with earnings management. I find that firms that submit auditor selection for shareholder ratification are more likely to have lower level of earnings management. Overall, the results suggest that the same factors that are associated with higher quality monitoring also may be associated with the submission of auditor selection for shareholder ratification vote. The results call into question the one-size-fits-all approach recommended by the ACAP.

Adult congenital heart disease : long-term survival, arrhytmias, and emerging therapy

Thèse numérisée par la Direction des bibliothèques de l'Université de Montréal.

Essays on Job Search and Labor Market Dynamics

This dissertation consists of three separate essays on job search and labor market dynamics. In the first essay, “The Impact of Labor Market Conditions on Job Creation: Evidence from Firm Level Data”, I study how much changes in labor market conditions reduce employment fluctuations over the business cycle. Changes in labor market conditions make hiring more expensive during expansions and cheaper during recessions, creating counter-cyclical incentives for job creation. I estimate firm level elasticities of labor demand with respect to changes in labor market conditions, considering two margins: changes in labor market tightness and changes in wages. Using employer-employee matched data from Brazil, I find that all firms are more sensitive to changes in wages rather than labor market tightness, and there is substantial heterogeneity in labor demand elasticity across regions. Based on these results, I demonstrate that changes in labor market conditions reduce the variance of employment growth over the business cycle by 20% in a median region, and this effect is equally driven by changes along each margin. Moreover, I show that the magnitude of the effect of labor market conditions on employment growth can be significantly affected by economic policy. In particular, I document that the rapid growth of the national minimum wages in Brazil in 1997-2010 amplified the impact of the change in labor market conditions during local expansions and diminished this impact during local recessions.

In the second essay, “A Framework for Estimating Persistence of Local Labor

Demand Shocks”, I propose a decomposition which allows me to study the persistence of local labor demand shocks. Persistence of labor demand shocks varies across industries, and the incidence of shocks in a region depends on the regional industrial composition. As a result, less diverse regions are more likely to experience deeper shocks, but not necessarily more long lasting shocks. Building on this idea, I propose a decomposition of local labor demand shocks into idiosyncratic location shocks and nationwide industry shocks and estimate the variance and the persistence of these shocks using the Quarterly Census of Employment and Wages (QCEW) in 1990-2013.

In the third essay, “Conditional Choice Probability Estimation of Continuous- Time Job Search Models”, co-authored with Peter Arcidiacono and Arnaud Maurel, we propose a novel, computationally feasible method of estimating non-stationary job search models. Non-stationary job search models arise in many applications, where policy change can be anticipated by the workers. The most prominent example of such policy is the expiration of unemployment benefits. However, estimating these models still poses a considerable computational challenge, because of the need to solve a differential equation numerically at each step of the optimization routine. We overcome this challenge by adopting conditional choice probability methods, widely used in dynamic discrete choice literature, to job search models and show how the hazard rate out of unemployment and the distribution of the accepted wages, which can be estimated in many datasets, can be used to infer the value of unemployment. We demonstrate how to apply our method by analyzing the effect of the unemployment benefit expiration on duration of unemployment using the data from the Survey of Income and Program Participation (SIPP) in 1996-2007.

Adult congenital heart disease : long-term survival, arrhytmias, and emerging therapy

Thèse numérisée par la Direction des bibliothèques de l'Université de Montréal.

Freshwater Resource Supply Modeling for Developed and Undeveloped Watersheds

Globally, the current state of freshwater resource management is insufficient and impeding the chance at a sustainable future. Human interference within the natural hydrologic cycle is becoming dangerously irreversible and the need to redefine resource managerial approaches is imminent. This research involves the development of a coupled natural-human freshwater resource supply model using a System Dynamics approach. The model was applied to two case studies, Somalia, Africa and the Phoenix Active Management Area in Arizona, USA. It is suggested that System Dynamic modeling would be an invaluable tool for achieving sustainable freshwater resource management in individual watersheds. Through a series of thought experiments, a thorough understanding of the systems’ dynamic behaviors is obtainable for freshwater resource managers and policy-makers to examine various courses of action for alleviating freshwater supply concerns. This thesis reviews the model, its development and an analysis of several thought experiments applied to the case studies.