831 resultados para Medicinal Product Liability
Resumo:
In this thesis a model for managing the product data in a product transfer project was created for ABB Machines. This model was then applied for the ongoing product transfer project during its planning phase. Detailed information about the demands and challenges in product transfer projects was acquired by analyzing previous product transfer projects in participating organizations. This analysis and the ABB Gate Model were then used as a base for the creation of the model for managing the product data in a product transfer project. The created model shows the main tasks during each phase in the project, their sub-tasks and relatedness on general level. Furthermore the model emphasizes need for detailed analysis of the situation during the project planning phase. The created model for managing the product data in a product transfer project was applied into ongoing project two main areas; manufacturing instructions and production item data. The results showed that the greatest challenge considering the product transfer project in previously mentioned areas is the current state of the product data. Based on the findings, process and resource proposals for both the ongoing product transfer project and the BU Machines were given. For manufacturing instructions it is necessary to create detailed process instructions in receiving organizations own language for each department so that the manufacturing instructions can be used as a training material during the training in sending organization. For production item data the English version of the bill of materials needs to be fully in English. In addition it needs to be ensured that bill of materials is updated and these changes implemented before the training in sending organization begins.
Resumo:
Notch is a membrane inserted protein activated by the membrane-inserted γ-secretase proteolytic complex. The Notch pathway is a potential therapeutic target for the treatment of renal diseases but also controls the function of other cells, requiring cell-targeting of Notch antagonists. Toward selective targeting, we have developed the γ-secretase inhibitor-based prodrugs 13a and 15a as substrates for γ-glutamyltranspeptidase (γ-GT) and/or γ-glutamylcyclotransferase (γ-GCT) as well as aminopeptidase A (APA), which are overexpressed in renal diseases, and have evaluated them in experimental in vitro and in vivo models. In nondiseased mice, the cleavage product from Ac-γ-Glu-γ-secretase inhibitor prodrug 13a (γ-GT-targeting and γ-GCT-targeting) but not from Ac-α-Glu-γ-secretase inhibitor prodrug 15a (APA-targeting) accumulated in kidneys when compared to blood and liver. Potential nephroprotective effects of the γ-secretase inhibitor targeted prodrugs were investigated in vivo in a mouse model of acute kidney injury, demonstrating that the expression of Notch1 and cleaved Notch1 could be selectively down-regulated upon treatment with the Ac-γ-Glu-γ-secretase-inhibitor 13a.
Resumo:
We examine the impact of governance mode and governance fit on performance in make-or-ally decisions. We argue that while horizontal collaboration and autonomous governance have direct and countervailing performance implications, the alignment of make-or-ally choices with the focal firm's resource endowment and the activity's resource requirements leads to better performance. Data on the aircraft industry show that relative to aircraft developed autonomously, collaborative aircraft exhibit greater sales but require longer time-to-market. However, governance fit increases unit sales and reduces time-to-market. We contribute to the alliance and economic organization literatures. (Copyright © 2013 John Wiley & Sons, Ltd.)
Resumo:
Objective The authors have sought to study the calibration of a clinical PKA meter (Diamentor E2) and a calibrator for clinical meters (PDC) in the Laboratory of Ionizing Radiation Metrology at Instituto de Energia e Ambiente - Universidade de São Paulo. Materials and Methods Different qualities of both incident and transmitted beams were utilized in conditions similar to a clinical setting, analyzing the influence from the reference dosimeter, from the distance between meters, from the filtration and from the average beam energy. Calibrations were performed directly against a standard 30 cm3 cylindrical chamber or a parallel-plate monitor chamber, and indirectly against the PDC meter. Results The lowest energy dependence was observed for transmitted beams. The cross calibration between the Diamentor E2 and the PDC meters, and the PDC presented the greatest propagation of uncertainties. Conclusion The calibration coefficient of the PDC meter showed to be more stable with voltage, while the Diamentor E2 calibration coefficient was more variable. On the other hand, the PDC meter presented greater uncertainty in readings (5.0%) than with the use of the monitor chamber (3.5%) as a reference.
Resumo:
The molecular basis of modern therapeutics consist in the modulation of cell function by the interaction of microbioactive molecules as drug cells macromolecules structures. Molecular modeling is a computational technique developed to access the chemical structure. This methodology, by means of the molecular similarity and complementary paradigm, is the basis for the computer-assisted drug design universally employed in pharmaceutical research laboratories to obtain more efficient, more selective, and safer drugs. In this work, we discuss some methods for molecular modeling and some approaches to evaluate new bioactive structures in development by our research group.
Resumo:
With the proposal to search for universal cooperation in the field of Medicinal Chemistry, the IUPAC group has elaborated a line of work divided into two phases: a- An Awareness of the true situation of Medicinal Chemistry in the different geographic areas of the world; b- A proposal of actions as to achieve more effective cooperation. This first report presents and discusses the actual situation in South and Central America as well as in sub-Saharan Africa.
Resumo:
This paper describes the chemical constituents isolated from roots of Pyrostegia venusta. From ethanol extract of the roots allantoin, beta-sitosterol, 3b-O-beta-D-glupyranosylsitosterol and hesperedin were isolated. The structures of these natural products were identified on the basis of spectral data, including 2D NMR of the peracetyl derivative of hesperidin.
Resumo:
Medicinal chemistry is multi, trans and inter disciplinary on its essence. It has a great deal of challenging Brazilian chemists in the next decade. The pharmacy school is essentially attached and has an important role in the development on the field that is still in domain of big pharmaceutical industries. This work shows the challenges to face and directions to jointly follow for a myriad of researchers throughout the country. The unnamed science has to work out through specific objectives in order to diminish the problems associated with human being health. A brief history is presented where the main goal is to devise chemistry, as a natural science, and many other interfaced disciplines.
Resumo:
In the area of drug discovery, natural products represent a myriad of templates for new lead discovery. It is, however, most unlikely that the bioactive principle itself shall become a drug; it is much more likely that a medicinal chemistry project needs to be initiated as soon the potency or selectivity or specificity of the new natural product candidate has been disclosed. Brazil has an enormous biodiversity where just a few has been disclosed. Nevertheless, it urges to initiate a joint collaboration in order to circumvent a major breakdown linking between natural products and medicinal chemistry in this country. This paper is intended to encourage people to follow up one of the most pushing forward enterprise that needs to be settled: the pharmaceutical industry.
Resumo:
This document here has been elaborated by the IUPAC Medicinal Chemistry section and is backed by a large number of scientists, many of whom have had direct involvement and whose names appear at the end of the article. This work discusses the role that the discovery of new medicinal agents has in the development of societies as well as in the conservation of biodiversity in terms of the work carried out on natural products. Also included are several recommendations for countries which are presently in search of their own scientific and technological development in medicinal agents. The IUPAC Medicinal Chemistry section would appreciate the collaboration of the scientific societies in every country to aid in the diffusion of this document.
Resumo:
The aim of this Thesis is to study how to manage the front-end of the offering planning process. This includes actual process development and methods to gather and analyze information to achieve the best outcome in customer oriented product offering. Study is carried out in two parts: theoretical part and company related part. Theoretical framework is created introducing different types of approaches to manage product planning processes. Products are seen as platforms and they are broken down to subsystems to show different parts of the development. With the help of the matrix-based approaches product platform related information is gathered and analyzed. In this kind of analysis business/market drivers and cus-tomer/competitor information are connected with product subsystems. This gives possibilities to study product gaps/needs and possible future ideas/scenarios in different customer segments. Company related part consists of offering planning process development in real company environment. Process formation includes documents and tools that guide planning from the information gathering to the prioritization and decision making.
Resumo:
The objective of this study was to find out how project success can be measured in a case where the output of a project is an intangible information product, what kind of framework can be used to evaluate the project success, and how the project assessment can be done in practice. As a case example, the success of a business blueprint project was assessed from the product point of view. A framework for assessing business blueprint project success was made based on a literature review. Furthermore, separate frameworks for measuring information product quality and project costs were developed. The theory of business blueprinting was discovered not to be firmly institutionalized and it is briefly covered in the thesis. The possible net benefits from the strategic business process harmonization were noted to be much more significant than the costs of the business blueprint project. The project was seen as a sufficient success from the viewpoint of the created output.
Resumo:
Globalization is the trend which is realized in all areas in today’s business world. Pressure for cost reduction, changes in market situation and available scale economies have changed business environment more global than ever. To respond to new situation, companies are establishing global strategies. In this thesis, available global competitive advantages in electrical machine industry are studied in context of gaining them by global technology transfers. In theory part, establishing global strategy and competitive advantage is considered with connection to global sourcing and supply chain management. Additionally, market development in 21st century and its impact on global strategies is studied. In practice, global manufacturing is enabled by technology transfer projects. Smooth and fast project implementation enables faster and more flexible production ramp up. By starting the production available competitive advantages can be realized. In this thesis the present situation of technology transfer projects and the risks and advantages related to global manufacturing are analyzed. The analysis of implemented technology transfer projects indicates that project implementation is in good level. For further development of project execution 10 minor suggestions could be presented with two major ones: higher level standardization and development of product information model to support better global manufacturing.