Customer-oriented NPD models for entrepreneurial firms

New Product Development (NPD) is an underutilised methodology in New Zealand. In this paper the authors review the literature on New Product Development, NPD theory and methods for early stage product design and development to make it better understood to SMEs.<br /

A Lattice Test of 1/N_c Baryon Mass Relations

1/N_c baryon mass relations are compared with lattice simulations of baryon masses using different values of the light-quark masses, and hence different values of SU(3) flavor-symmetry breaking. The lattice data clearly display both the 1/N_c and SU(3) flavor-symmetry breaking hierarchies. The validity of 1/N_c baryon mass relations derived without assuming approximate SU(3) flavor-symmetry also can be tested by lattice data at very large values of the strange quark mass. The 1/N_c expansion constrains the form of discretization effects; these are suppressed by powers of 1/N_c by taking suitable combinations of masses. This 1/N_c scaling is explicitly demonstrated in the present work.Comment: 13 pages, 20 figures; v2 version to be published in PR

Bibliography of Mountain Biking Research: 1990-2021

Since the 1980s, mountain biking as an outdoor recreation activity has grown rapidly worldwide. Research on mountain biking is growing across many academic disciplines, from medicine to outdoor recreation and tourism research. This bibliography includes peer-reviewed research published on mountain biking within the context of natural resource management from 1990-2021

Individual pulmonary vein size and survival in infants with totally anomalous pulmonary venous connection

AbstractObjectives. We investigated whether mortality in totally anomalous pulmonary venous connection could be predicted from preoperative individual pulmonary vein size.Background. Some infants with this anomaly die with or without surgical repair because of stenosis of individual pulmonary veins.Methods. Individual pulmonary vein, vertical vein and pulmonary venous confluence diameters were retrospectively measured from preoperative echocardiograms in 32 infants with totally anomalous pulmonary venous connection presenting to Children's Hospital, Boston over a 1/2-year period. Data on body surface area, other cardiac anomalies, presence of initial pulmonary venous obstruction and early surgery and outcome were also recorded.Results. Of 32 patients, 6 (18.8%) died before hospital discharge, and 8 (25.0%) died subsequently. Six (75.0%) of the eight patients who died late had individual pulmonary vein stenosis at sites remote from the surgical anastomosis to the left atrium. The remaining 18 patients (56.3%) are alive at a mean follow-up period of 9.7 months. A Cox proportional hazard model revealed that small sum of individual pulmonary vein diameters (p = 0.0004), small confluence size (p = 0.02) and presence of heterotaxy syndrome (p = 0.008) were each significant univariate predictors of survival. Multivariate analysis showed that small pulmonary vein sum was a strong predictor of survival (p = 0.008), independent of the presence of heterotaxy syndrome. An analysis stratified by the presence of heterotaxy syndrome showed that the predictive effect of small pulmonary vein sum on survival was strongest in patients without heterotaxy syndrome.Conclusions. These data show that individual pulmonary vein size at diagnosis is a strong, independent predictor of survival in patients with totally anomalous pulmonary venous connection. In patients with this anomaly and small individual pulmonary veins, the anomaly may not be correctable by surgical creation of an anastomosis between the pulmonary venous confluence and the left atrium

Content Uniformity of Over-the-Counter Melatonin

Dietary supplements are loosely regulated in comparison to over-the-counter and prescription drugs. Numerous tests for safety and efficacy are required before drugs can be marketed. However, the Food and Drug Administration does not require thorough examination of supplements before they are sold. Dietary supplements generally adhere to the phrase, “safe, until proven unsafe,” with safety determined solely through post-market adverse event reports. Substandard regulation of supplement manufacturing leads to warranted doubt about the safety and efficacy of dietary supplements. Within the dietary supplement market there are regulatory bodies, such as the United States Pharmacopeia (USP), that provide optional verification services to manufacturers. If utilized, these regulatory bodies ensure that manufacturers meet specific standards in regard to Current Good Manufacturing Practices (cGMP), purity of ingredients, and overall integrity of their product. Numerous studies have revealed a history of inaccuracies in supplement product labeling. Researchers conducting these studies consistently conclude that there is a need for stricter regulation and finer application of cGMP within supplement manufacturing companies. One of the most popular dietary supplements on the market, melatonin, has been the focus in a number of studies evaluating supplement product content integrity. Melatonin is commonly used to treat insomnia and to cure symptoms of jet lag. According to past research, these melatonin products often contain an amount of active ingredient that significantly differs from respective product labeling. Most research regarding melatonin product integrity has occurred outside of the past ten years, leaving the need for newer research. Melatonin 3 mg will be purchased from six different manufacturers with three manufacturers possessing USP verification. Within each manufacturer, melatonin 3 mg from five separate lot numbers will be purchased. Ten tablets from each bottle (totaling 300 tablets) will be analyzed using a high-pressure liquid chromatography machine in order to determine actual melatonin content in each tablet. Data will be recorded and compared to determine accuracy of product labeling and batch-to-batch content uniformity. Data from USP-verified melatonin will be compared with non-verified products in order to determine if regulatory body verification is effective at improving content uniformity

The subendothelial extracellular matrix modulates NF-κB activation by flow: a potential role in atherosclerosis

Atherosclerotic plaque forms in regions of the vasculature exposed to disturbed flow. NF-κB activation by fluid flow, leading to expression of target genes such as E-selectin, ICAM-1, and VCAM-1, may regulate early monocyte recruitment and fatty streak formation. Flow-induced NF-κB activation is downstream of conformational activation of integrins, resulting in new integrin binding to the subendothelial extracellular matrix and signaling. Therefore, we examined the involvement of the extracellular matrix in this process. Whereas endothelial cells plated on fibronectin or fibrinogen activate NF-κB in response to flow, cells on collagen or laminin do not. In vivo, fibronectin and fibrinogen are deposited at atherosclerosis-prone sites before other signs of atherosclerosis. Ligation of integrin α2β1 on collagen prevents flow-induced NF-κB activation through a p38-dependent pathway that is activated locally at adhesion sites. Furthermore, altering the extracellular matrix to promote p38 activation in cells on fibronectin suppresses NF-κB activation, suggesting a novel therapeutic strategy for treating atherosclerosis

Developing a batch isolation procedure and running it in an automated semi-continuous unit : AWL CFD25 case study

A key challenge during the transition from laboratory/small batch to continuous manufacturing is the development of a process strategy that can easily be adopted for a larger batch/continuous process. Industrial practice is to develop the isolation strategy for a new drug/process in batch using the design of experiment (DoE) approach to determine the best isolation conditions and then transfer the isolation parameters selected to a large batch equipment/continuous isolation process. This stage requires a series of extra investigations to evaluate the effect of different equipment geometry or even the adaptation of the parameters selected to a different isolation mechanism (e.g., from dead end to cross flow filtration) with a consequent increase of R&D cost and time along with an increase in material consumption. The CFD25 is an isolation device used in the first instance to develop an isolation strategy in batch (optimization mode) using a screening DoE approach and to then verify the transferability of the strategy to a semicontinuous process (production mode). A d-optimal screening DoE was used to determine the effect of varying the input slurry. Properties such as solid loading, particle size distribution, and crystallization solvent were investigated to determine their impact on the filtration and washing performance and the characteristics of the dry isolated product. A series of crystallization (ethanol, isopropanol, and 3-methylbutan-1-ol) and wash solvents (n-heptane, isopropyl acetate and n-dodcane) were used for the process. To mimic a real isolation process, paracetamol-related impurities, acetanilide and metacetamol, were dissolved in the mother liquor. The selected batch isolation strategy was used for the semicontinuous isolation run. Throughput and filtration parameters, such as cake resistance and flow rate, cake residual liquid content and composition, cake purity, particle-particle aggregation, and extent and strength of agglomerates, were measured to evaluate the consistency of the isolated product produced during a continuous experiment and compared with the isolated product properties obtained during the batch process development. Overall, the CFD25 is a versatile tool which allows both new chemical entity process development in batch and the production of the active pharmaceutical ingredient in semicontinuous mode using the same process parameters without changing equipment. The isolated product properties gained during the semicontinuous run are overall comparable between samples. The residual solvent content and composition differs between some samples due to filter plate blockage. In general, the mean properties obtained during semicontinuous running are comparable with the product properties simulated using the DoE

Developing a pressure ulcer risk factor minimum data set and risk assessment framework

AIM: To agree a draft pressure ulcer risk factor Minimum Data Set to underpin the development of a new evidenced-based Risk Assessment Framework.BACKGROUND: A recent systematic review identified the need for a pressure ulcer risk factor Minimum Data Set and development and validation of an evidenced-based pressure ulcer Risk Assessment Framework. This was undertaken through the Pressure UlceR Programme Of reSEarch (RP-PG-0407-10056), funded by the National Institute for Health Research and incorporates five phases. This article reports phase two, a consensus study.DESIGN: Consensus study.METHOD: A modified nominal group technique based on the Research and Development/University of California at Los Angeles appropriateness method. This incorporated an expert group, review of the evidence and the views of a Patient and Public Involvement service user group. Data were collected December 2010-December 2011.FINDINGS: The risk factors and assessment items of the Minimum Data Set (including immobility, pressure ulcer and skin status, perfusion, diabetes, skin moisture, sensory perception and nutrition) were agreed. In addition, a draft Risk Assessment Framework incorporating all Minimum Data Set items was developed, comprising a two stage assessment process (screening and detailed full assessment) and decision pathways.CONCLUSION: The draft Risk Assessment Framework will undergo further design and pre-testing with clinical nurses to assess and improve its usability. It will then be evaluated in clinical practice to assess its validity and reliability. The Minimum Data Set could be used in future for large scale risk factor studies informing refinement of the Risk Assessment Framework