Quality control of pharmaceutical ingredients:developing a caking test for industry

Objectives - Powdered and granulated particulate materials make up most of the ingredients of pharmaceuticals and are often at risk of undergoing unwanted agglomeration, or caking, during transport or storage. This is particularly acute when bulk powders are exposed to extreme swings in temperature and relative humidity, which is now common as drugs are produced and administered in increasingly hostile climates and are stored for longer periods of time prior to use. This study explores the possibility of using a uniaxial unconfined compression test to compare the strength of caked agglomerates exposed to different temperatures and relative humidities. This is part of a longer-term study to construct a protocol to predict the caking tendency of a new bulk material from individual particle properties. The main challenge is to develop techniques that provide repeatable results yet are presented simply enough to be useful to a wide range of industries. Methods - Powdered sucrose, a major pharmaceutical ingredient, was poured into a split die and exposed to high and low relative humidity cycles at room temperature. The typical ranges were 20–30% for the lower value and 70–80% for the higher value. The outer die casing was then removed and the resultant agglomerate was subjected to an unconfined compression test using a plunger fitted to a Zwick compression tester. The force against displacement was logged so that the dynamics of failure as well as the failure load of the sample could be recorded. The experimental matrix included varying the number of cycles, the amount between the maximum and minimum relative humidity, the height and diameters of the samples, the number of cycles and the particle size. Results - Trends showed that the tensile strength of the agglomerates increased with the number of cycles and also with the more extreme swings in relative humidity. This agrees with previous work on alternative methods of measuring the tensile strength of sugar agglomerates formed from humidity cycling (Leaper et al 2003). Conclusions - The results show that at the very least the uniaxial tester is a good comparative tester to examine the caking tendency of powdered materials, with a simple arrangement and operation that are compatible with the requirements of industry. However, further work is required to continue to optimize the height/ diameter ratio during tests.

Novel speech signal processing algorithms for high-accuracy classification of Parkinson's disease

There has been considerable recent research into the connection between Parkinson's disease (PD) and speech impairment. Recently, a wide range of speech signal processing algorithms (dysphonia measures) aiming to predict PD symptom severity using speech signals have been introduced. In this paper, we test how accurately these novel algorithms can be used to discriminate PD subjects from healthy controls. In total, we compute 132 dysphonia measures from sustained vowels. Then, we select four parsimonious subsets of these dysphonia measures using four feature selection algorithms, and map these feature subsets to a binary classification response using two statistical classifiers: random forests and support vector machines. We use an existing database consisting of 263 samples from 43 subjects, and demonstrate that these new dysphonia measures can outperform state-of-the-art results, reaching almost 99% overall classification accuracy using only ten dysphonia features. We find that some of the recently proposed dysphonia measures complement existing algorithms in maximizing the ability of the classifiers to discriminate healthy controls from PD subjects. We see these results as an important step toward noninvasive diagnostic decision support in PD.

Rapid testing for group B streptococcus during labour: a test accuracy study with evaluation of acceptability and cost-effectiveness

OBJECTIVE: To determine the accuracy, acceptability and cost-effectiveness of polymerase chain reaction (PCR) and optical immunoassay (OIA) rapid tests for maternal group B streptococcal (GBS) colonisation at labour. DESIGN: A test accuracy study was used to determine the accuracy of rapid tests for GBS colonisation of women in labour. Acceptability of testing to participants was evaluated through a questionnaire administered after delivery, and acceptability to staff through focus groups. A decision-analytic model was constructed to assess the cost-effectiveness of various screening strategies. SETTING: Two large obstetric units in the UK. PARTICIPANTS: Women booked for delivery at the participating units other than those electing for a Caesarean delivery. INTERVENTIONS: Vaginal and rectal swabs were obtained at the onset of labour and the results of vaginal and rectal PCR and OIA (index) tests were compared with the reference standard of enriched culture of combined vaginal and rectal swabs. MAIN OUTCOME MEASURES: The accuracy of the index tests, the relative accuracies of tests on vaginal and rectal swabs and whether test accuracy varied according to the presence or absence of maternal risk factors. RESULTS: PCR was significantly more accurate than OIA for the detection of maternal GBS colonisation. Combined vaginal or rectal swab index tests were more sensitive than either test considered individually [combined swab sensitivity for PCR 84% (95% CI 79-88%); vaginal swab 58% (52-64%); rectal swab 71% (66-76%)]. The highest sensitivity for PCR came at the cost of lower specificity [combined specificity 87% (95% CI 85-89%); vaginal swab 92% (90-94%); rectal swab 92% (90-93%)]. The sensitivity and specificity of rapid tests varied according to the presence or absence of maternal risk factors, but not consistently. PCR results were determinants of neonatal GBS colonisation, but maternal risk factors were not. Overall levels of acceptability for rapid testing amongst participants were high. Vaginal swabs were more acceptable than rectal swabs. South Asian women were least likely to have participated in the study and were less happy with the sampling procedure and with the prospect of rapid testing as part of routine care. Midwives were generally positive towards rapid testing but had concerns that it might lead to overtreatment and unnecessary interference in births. Modelling analysis revealed that the most cost-effective strategy was to provide routine intravenous antibiotic prophylaxis (IAP) to all women without screening. Removing this strategy, which is unlikely to be acceptable to most women and midwives, resulted in screening, based on a culture test at 35-37 weeks' gestation, with the provision of antibiotics to all women who screened positive being most cost-effective, assuming that all women in premature labour would receive IAP. The results were sensitive to very small increases in costs and changes in other assumptions. Screening using a rapid test was not cost-effective based on its current sensitivity, specificity and cost. CONCLUSIONS: Neither rapid test was sufficiently accurate to recommend it for routine use in clinical practice. IAP directed by screening with enriched culture at 35-37 weeks' gestation is likely to be the most acceptable cost-effective strategy, although it is premature to suggest the implementation of this strategy at present.

Leveraging employee creativity through high performance work systems:a multilevel perspective

Research has looked at single rather than a configuration of human resource management (HRM) practices to influence creativity so it is not yet clear how these practices synergistically facilitate creativity and organisational performance. I address this significant but unanswered question in a three-part study. In Study 1, I develop a high performance work system (HPWS) for creativity scale. I use Study 2 sample to test the validity of the new scale. In Study 3, I test a multilevel model of the intervening processes through which branch HPWS for creativity influences creativity and branch performance. Specifically, at the branch level, I draw on social context theory and hypothesise that branch HPWS for creativity relates to climate for creativity which, in turn, leads to creativity, and ultimately, to profit. Furthermore, I hypothesise environmental dynamism as a boundary condition of the creativity-profit relationship. At the individual level, I hypothesise a cross-level effect of branch HPWS for creativity on employee-perceived HPWS. I draw on self-determination theory and argue that perceived HPWS for creativity relate to need satisfaction and the psychological pathways of intrinsic motivation and creative process engagement to predict creativity. I also hypothesise climate for creativity as a cross-level moderator of the intrinsic motivation-creativity and creative process engagement-creativity relationships. Results of hierarchical linear modeling (HLM) indicate that ten out of the fifteen hypotheses were supported. The findings of this study respond to calls for HPWS to be designed around a strategic focus by developing and providing initial validity evidence of an HPWS for creativity scale. The results reveal the underlying mechanisms through which HPWS for creativity simultaneously influences individual and branch creativity leading to profit. Lastly, results indicate environmental dynamism to be an important boundary condition of the creativity-profit relationship and climate for creativity as a cross-level moderator of the creative process engagement-creativity.

Parametric Identification and Diagnosis of Integrated Navigation Systems in Bench Test Process

Growth of complexity and functional importance of integrated navigation systems (INS) leads to high losses at the equipment refusals. The paper is devoted to the INS diagnosis system development, allowing identifying the cause of malfunction. The proposed solutions permit taking into account any changes in sensors dynamic and accuracy characteristics by means of the appropriate error models coefficients. Under actual conditions of INS operation, the determination of current values of the sensor models and estimation filter parameters rely on identification procedures. The results of full-scale experiments are given, which corroborate the expediency of INS error models parametric identification in bench test process.

Comparison of the measurement performance of high precision multi-axis metal cutting machine tools

High precision manufacturers continuously seek out disruptive technologies to improve the quality, cost, and delivery of their products. With the advancement of machine tool and measurement technology many companies are ready to capitalise on the opportunity of on-machine measurement (OMM). Coupled with business case, manufacturing engineers are now questioning whether OMM can soon eliminate the need for post-process inspection systems. Metrologists will however argue that the machining environment is too hostile and that there are numerous process variables which need consideration before traceable measurement on-the-machine can be achieved. In this paper we test the measurement capability of five new multi-axis machine tools enabled as OMM systems via on-machine probing. All systems are tested under various operating conditions in order to better understand the effects of potentially significant variables. This investigation has found that key process variables such as machine tool warm-up and tool-change cycles can have an effect on machine tool measurement repeatability. New data presented here is important to many manufacturers whom are considering utilising their high precision multi-axis machine tools for both the creation and verification of their products.

A Comparative Analysis of Predictive Learning Algorithms on High-Dimensional Microarray Cancer Data

This research evaluates pattern recognition techniques on a subclass of big data where the dimensionality of the input space (p) is much larger than the number of observations (n). Specifically, we evaluate massive gene expression microarray cancer data where the ratio κ is less than one. We explore the statistical and computational challenges inherent in these high dimensional low sample size (HDLSS) problems and present statistical machine learning methods used to tackle and circumvent these difficulties. Regularization and kernel algorithms were explored in this research using seven datasets where κ < 1. These techniques require special attention to tuning necessitating several extensions of cross-validation to be investigated to support better predictive performance. While no single algorithm was universally the best predictor, the regularization technique produced lower test errors in five of the seven datasets studied.

Using overlay test to evaluate fracture properties of field-aged asphalt concrete

Field material testing provides firsthand information on pavement conditions which are most helpful in evaluating performance and identifying preventive maintenance or overlay strategies. High variability of field asphalt concrete due to construction raises the demand for accuracy of the test. Accordingly, the objective of this study is to propose a reliable and repeatable methodology to evaluate the fracture properties of field-aged asphalt concrete using the overlay test (OT). The OT is selected because of its efficiency and feasibility for asphalt field cores with diverse dimensions. The fracture properties refer to the Paris’ law parameters based on the pseudo J-integral (A and n) because of the sound physical significance of the pseudo J-integral with respect to characterizing the cracking process. In order to determine A and n, a two-step OT protocol is designed to characterize the undamaged and damaged behaviors of asphalt field cores. To ensure the accuracy of determined undamaged and fracture properties, a new analysis method is then developed for data processing, which combines the finite element simulations and mechanical analysis of viscoelastic force equilibrium and evolution of pseudo displacement work in the OT specimen. Finally, theoretical equations are derived to calculate A and n directly from the OT test data. The accuracy of the determined fracture properties is verified. The proposed methodology is applied to a total of 27 asphalt field cores obtained from a field project in Texas, including the control Hot Mix Asphalt (HMA) and two types of warm mix asphalt (WMA). The results demonstrate a high linear correlation between n and −log A for all the tested field cores. Investigations of the effect of field aging on the fracture properties confirm that n is a good indicator to quantify the cracking resistance of asphalt concrete. It is also indicated that summer climatic condition clearly accelerates the rate of aging. The impact of the WMA technologies on fracture properties of asphalt concrete is visualized by comparing the n-values. It shows that the Evotherm WMA technology slightly improves the cracking resistance, while the foaming WMA technology provides the comparable fracture properties with the HMA. After 15 months aging in the field, the cracking resistance does not exhibit significant difference between HMA and WMAs, which is confirmed by the observations of field distresses.

High-accuracy discrimination of Parkinson’s Disease participants from healthy controls using smartphones

Objective: To test the practicality and effectiveness of cheap, ubiquitous, consumer-grade smartphones to discriminate Parkinson’s disease (PD) subjects from healthy controls, using self-administered tests of gait and postural sway. Background: Existing tests for the diagnosis of PD are based on subjective neurological examinations, performed in-clinic. Objective movement symptom severity data, collected using widely-accessible technologies such as smartphones, would enable the remote characterization of PD symptoms based on self-administered, behavioral tests. Smartphones, when backed up by interviews using web-based videoconferencing, could make it feasible for expert neurologists to perform diagnostic testing on large numbers of individuals at low cost. However, to date, the compliance rate of testing using smart-phones has not been assessed. Methods: We conducted a one-month controlled study with twenty participants, comprising 10 PD subjects and 10 controls. All participants were provided identical LG Optimus S smartphones, capable of recording tri-axial acceleration. Using these smartphones, patients conducted self-administered, short (less than 5 minute) controlled gait and postural sway tests. We analyzed a wide range of summary measures of gait and postural sway from the accelerometry data. Using statistical machine learning techniques, we identified discriminating patterns in the summary measures in order to distinguish PD subjects from controls. Results: Compliance was high all 20 participants performed an average of 3.1 tests per day for the duration of the study. Using this test data, we demonstrated cross-validated sensitivity of 98% and specificity of 98% in discriminating PD subjects from healthy controls. Conclusions: Using consumer-grade smartphone accelerometers, it is possible to distinguish PD from healthy controls with high accuracy. Since these smartphones are inexpensive (around $30 each) and easily available, and the tests are highly non-invasive and objective, we envisage that this kind of smartphone-based testing could radically increase the reach and effectiveness of experts in diagnosing PD.

Evaluation of applying retaining shield rotor for high-speed interior permanent magnet motors

This paper proposes a novel rotor structure for high-speed interior permanent magnet motors to overcome huge centrifugal forces under high-speed operation. Instead of the conventional axial stacking of silicon-steel laminations, the retaining shield rotor is inter-stacked by high-strength stainless-steel plates to enhance the rotor strength against the huge centrifugal force. Both mechanical characteristics and electromagnetic behaviors of the retaining shield rotor are analyzed using finite-element method in this paper. Prototypes and experimental results are demonstrated to evaluate the performance. The analysis and test results show that the proposed retaining shield rotor could effectively enhance the rotor strength without a significant impact on the electromagnetic performance, while some design constraints should be compromised.

Effectiveness of peer counseling on high school students who failed two or more classes in a nine week quarter

The purpose of this study was to examine the effectiveness of peer counseling on high school students who have previously failed two or more classes in a nine week quarter.^ This study was constructed by comparing students who previously failed and were subsequently given peer counseling with a matched group of students who failed and did not receive peer counseling.^ To test the proposed research question, 324 students from a large urban school system were randomly chosen from a computer generated list of students who failed courses, matched on variables of number of classes failed, grade level and gender. One student from each matched pair was randomly placed in either the experimental or control group. 162 students from Group 1 (experimental) were assigned a peer counselor with their pair assigned to Group 2 (control). Group 1 received peer counseling at least 4 times during the third nine week academic quarter (Quarter 3) while Group 2 did not.^ The Grade Point Averages (GPA) for all students were collected both at the end of Quarter 2 and Quarter 3, at which time peer counseling was terminated. GPA's were also collected nine weeks after counseling was terminated.^ Results were determined by multiple regression, analysis of covariance and t-test. A level of significance was set at.05. There was significant increase in the GPA's of those counseled students immediately after peer counseling and also nine weeks after counseling was terminated, while the group not receiving peer counseling showed no increase. It was noted that there were significantly more school drop-outs from the non-counseled group than the counseled group. The number of classes failed, high school attended, grade level and gender were not found to be significant.^ The conclusion from this study was that peer counseling does impact significantly on the GPA's of students experiencing academic failure. Recommendations from this study were to implement and expand peer counseling programs with more failing students, continue counseling for longer than one quarter, include students in drop-out programs and students from different socio-economic and racial backgrounds, and conduct subsequent evaluation. ^

Market definition in industrial high-technology markets

This dissertation analyzes how marketers define markets in technology-based industries. One of the most important strategic decisions marketers face is determining the optimal market for their products. Market definition is critical in dynamic high technology markets characterized by high levels of market and technological uncertainty. Building on literature from marketing and related disciplines, this research is the first in-depth study of market definition in industrial markets. Using a national, probability sample stratified by firm size, 1,000 marketing executives in nine industries (automation, biotechnology, computers, medical equipment and instrumentation, pharmaceuticals, photonics, software, subassemblies and components, and telecommunications) were surveyed via a mail questionnaire. A 20.8% net response rate yielding 203 surveys was achieved. The market structure-conduct-performance (SCP) paradigm from industrial organization provided a conceptual basis for testing a causal market definition model via LISREL. A latent exogenous variable (competitive intensity) and four latent endogenous variables (marketing orientation, technological orientation, market definition criteria, and market definition success) were used to develop and test hypothesized relationships among constructs. Research questions relating to market redefinition, market definition characteristics, and internal (within the firm) and external (competitive) market definition were also investigated. Market definition success was found to be positively associated with a marketing orientation and the use of market definition criteria. Technological orientation was not significantly related to market definition success. Customer needs were the key market definition characteristic to high-tech firms (technology, competition, customer groups, and products were also important). Market redefinition based on changing customer needs was the most effective of seven strategies tested. A majority of firms regularly defined their market at the corporate and product-line level within the firm. From a competitive perspective, industry, industry sector, and product-market definitions were used most frequently.

The effect of vocational education on high school students in a large urban multicultural school district

The completion of and graduation from high school is a major problem that must be resolved. A 6% random sample of the students (1,059) who were in the 9th grade in Miami-Dade Public Schools, a large urban school district, September 1992, were selected for this study. The sample was divided into 2 groups, advanced academic and general track students. Each group was then divided into vocational and non-vocational. A causal comparative design was used to evaluate the results for graduate vs. non-graduate. The indicators were the program of study, attendance, standardized test scores, grade point average, ethnicity and gender. It was found that both advanced academic and general track students had significantly higher graduation rates at the .01 level when a vocational education program was part of their studies. All of the other indicators did not show any significant differences. If we arc to improve students educational outcomes and reduce the dropout rate, vocational education should be part of every student's education.^

A comparison of the academic performance of students with General Educational Development credentials and high school diplomas at a selected community college

This study compared the performance of students who earned GED credentials in Florida with that of graduates of Florida high schools, when members of both groups enrolled for the first time in fall 1992 at an urban multicultural community college in south Florida. GED's and HSD's were matched on gender, race, age range, placement levels, and enrollment in college preparatory courses (reading, English, mathematics). The paired samples t-test compared course grades, first semester GPA, and total college GPA for the groups and subgroups of matched students at a probability level of .05. The McNemar test compared how many students in each group and subgroup re-enrolled for a second and third term, or ever; how many were placed on special academic status during their college enrollment; and how many graduated within 16 semesters. Differences between groups were found only for placement on probation—with HSD's on probation in significantly higher proportion than GED's. ^ Additional findings among subgroups revealed that male and Caucasian HSD subjects earned higher math grades than their GED counterparts. Male HSD's were more likely than male GED's to return to the college at some point after the first term. However, male HSD's were placed on probation in greater proportion than the GED's with whom they were matched. ^ Female GED's earned higher English grades and higher first semester and cumulative GPA's and returned to the college in greater proportion than their HSD counterparts. Black GED's earned higher first-semester GPA's, re-enrolled in terms 2 and 3 and graduated from the college in higher percentages than Black HSD's. Black HSD's were placed on probation in higher proportion than Black GED's. Lastly, greater percentages of HSD than GED subjects in the lowest age range (16–19) were placed on probation. ^ Results connected to the performance of Black GED subjects are likely to have been affected by the fact that 50% of Black study subjects had been born in Jamaica. The place of the GED in the constellation of methods for earning credit by examination is explored, future implications are discussed, and further study is recommended. ^

Academic performance of college students in financial management and related prerequisite courses: A comparison of senior high school and commercial high school graduates attending Tamsui Oxford University College in Taiwan

In Taiwan, the college freshmen are recruited graduates of both senior high school and senior vocational school. The Ministry of Education (MOE) of the Republic of China prescribes the standards of curriculum and equipment for schools at all levels and categories. There exists a considerably different curriculum arrangement for senior high schools and vocational high schools in Taiwan at the present time. The present study used a causal-comparative research design to identify the influences of different post-secondary educational background on specialized course performance of college business majors. ^ The students involved in this study were limited to the students of four business-related departments at Tamsui Oxford University College in Taiwan. Students were assigned to comparison groups based on their post-secondary educational background as senior high school graduates and commercial high school graduates. The analysis of this study included a comparison of students' performance on lower level courses and a comparison of students' performance in financial management. The analysis also considered the relationship between the students' performance in financial management and its related prerequisite courses. The Kolb Learning Style Inventory (LSI) survey was administered to categorize subjects' learning styles and to compare the learning styles between the two groups in this study. The applied statistical methods included t-test, correlation, multiple regression, and Chi-square. ^ The findings of this study indicated that there were significant differences between the commercial high school graduates and the senior high school graduates on academic performances in specialized courses but not in general courses. There were no significant differences in learning styles between the two groups. These findings lead to the conclusion that business majors' academic performance in specialized courses were influenced by their post-secondary educational background. ^