Current and future trens in the quality control of pharmaceuticals and biopharmaticals : impacts on Cost of Goods Sold (COGS)

[Summary] 2. Roles of quality control in the pharmaceutical and biopharmaceutical industries. - 2.1. Pharmaceutical industry. - 2.2. Biopharmaceutical industry. - 2.3. Policy and regulatory. - 2.3.1. The US Food and Drug Administration (FDA). - 2.3.2. The European Medicine Agency (EMEA). - 2.3.3. The Japanese Ministry of Work, Labor and Welfare (MHLW). - 2.3.4. The Swiss Agency for Therapeutic Products (Swissmedic). - 2.3.5. The International Conference on Harmonization (ICH). - - 3. Types of testing. - 3.1. Microbiological purity tests. - 3.2. Physiochemical tests. - 3.3. Critical to quality steps. - 3.3.1. API starting materials and excipients. - 3.3.2. Intermediates. - 3.3.3. APIs (drug substances) and final drug product. - 3.3.4. Primary and secondary packaging materials fro drug products. - - 4. Manufacturing cost and quality control. - 4.1.1. Pharmaceutical manufacturing cost breakdown. - 4.1.2. Biopharmaceutical manufacturing cost breakdown. - 4.2. Batch failure / rejection / rework / recalls. - - 5. Future trends in the quality control of pharmaceuticals and biopharmaceuticals. - 5.1. Rapid and real time testing. - 5.1.1. Physio-chemicals testing. - 5.1.2. Rapid microbiology methods

Solitary pulmonary nodule and 18F-FDG PET/CT. Part 2: accuracy, cost-effectiveness, and current recommendations

Abstract A solitary pulmonary nodule is a common, often incidental, radiographic finding. The investigation and differential diagnosis of solitary pulmonary nodules remain complex, because there are overlaps between the characteristics of benign and malignant processes. There are currently many strategies for evaluating solitary pulmonary nodules. The main objective is to identify benign lesions, in order to avoid exposing patients to the risks of invasive methods, and to detect cases of lung cancer accurately, in order to avoid delaying potentially curative treatment. The focus of this study was to review the evaluation of solitary pulmonary nodules, to discuss the current role of 18F-fluorodeoxyglucose positron-emission tomography, addressing its accuracy and cost-effectiveness, and to detail the current recommendations for the examination in this scenario.

Opinion Mining

In this thesis we study the field of opinion mining by giving a comprehensive review of the available research that has been done in this topic. Also using this available knowledge we present a case study of a multilevel opinion mining system for a student organization's sales management system. We describe the field of opinion mining by discussing its historical roots, its motivations and applications as well as the different scientific approaches that have been used to solve this challenging problem of mining opinions. To deal with this huge subfield of natural language processing, we first give an abstraction of the problem of opinion mining and describe the theoretical frameworks that are available for dealing with appraisal language. Then we discuss the relation between opinion mining and computational linguistics which is a crucial pre-processing step for the accuracy of the subsequent steps of opinion mining. The second part of our thesis deals with the semantics of opinions where we describe the different ways used to collect lists of opinion words as well as the methods and techniques available for extracting knowledge from opinions present in unstructured textual data. In the part about collecting lists of opinion words we describe manual, semi manual and automatic ways to do so and give a review of the available lists that are used as gold standards in opinion mining research. For the methods and techniques of opinion mining we divide the task into three levels that are the document, sentence and feature level. The techniques that are presented in the document and sentence level are divided into supervised and unsupervised approaches that are used to determine the subjectivity and polarity of texts and sentences at these levels of analysis. At the feature level we give a description of the techniques available for finding the opinion targets, the polarity of the opinions about these opinion targets and the opinion holders. Also at the feature level we discuss the various ways to summarize and visualize the results of this level of analysis. In the third part of our thesis we present a case study of a sales management system that uses free form text and that can benefit from an opinion mining system. Using the knowledge gathered in the review of this field we provide a theoretical multi level opinion mining system (MLOM) that can perform most of the tasks needed from an opinion mining system. Based on the previous research we give some hints that many of the laborious market research tasks that are done by the sales force, which uses this sales management system, can improve their insight about their partners and by that increase the quality of their sales services and their overall results.

Climate Change and the Cost of Carbon Sequestration: The Case of Forest Management

The Kyoto protocol allows Annex I countries to deduct carbon sequestered by land use, land-use change and forestry from their national carbon emissions. Thornley and Cannell (2000) demonstrated that the objectives of maximizing timber and carbon sequestration are not complementary. Based on this finding, this paper determines the optimal selective management regime taking into account the underlying biophysical and economic processes. The results show that the net benefits of carbon storage only compensate the decrease in net benefits of timber production once the carbon price has exceeded a certain threshold value. The sequestration costs are significantly lower than previous estimates

Profile, cost and pattern of prescriptions for polymedicated patients in Catalonia, Spain

OBJECTIVES: Polypharmacy is one of the main management issues in public health policies because of its financial impact and the increasing number of people involved. The polymedicated population according to their demographic and therapeutic profile and the cost for the public healthcare system were characterised. DESIGN: Cross-sectional study. SETTING: Primary healthcare in Barcelona Health Region, Catalonia, Spain (5 105 551 inhabitants registered). PARTICIPANTS: All insured polymedicated patients. Polymedicated patients were those with a consumption of ≥16 drugs/month. MAIN OUTCOMES MEASURES: The study variables were related to age, gender and medication intake obtained from the 2008 census and records of prescriptions dispensed in pharmacies and charged to the public health system. RESULTS: There were 36 880 polymedicated patients (women: 64.2%; average age: 74.5±10.9 years). The total number of prescriptions billed in 2008 was 2 266 830 (2 272 920 total package units). The most polymedicated group (up to 40% of the total prescriptions) was patients between 75 and 84 years old. The average number of prescriptions billed monthly per patient was 32±2, with an average cost of 452.7±27.5. The total cost of those prescriptions corresponded to 2% of the drug expenditure in Catalonia. The groups N, C, A, R and M represented 71.4% of the total number of drug package units dispensed to polymedicated patients. Great variability was found between the medication profiles of men and women, and between age groups; greater discrepancies were found in paediatric patients (5-14 years) and the elderly (≥65 years). CONCLUSIONS: This study provides essential information to take steps towards rational drug use and a structured approach in the polymedicated population in primary healthcare.

Fair value versus historic cost-valuation for biological assets: Implications for the quality of financial information

[spa] Este trabajo realiza un estudio empírico sobre los efectos, que se señalan en las discusiones teóricas, de la utilización del valor razonable (VR) frente al coste histórico (CH), utilizando dos muestras de explotaciones agrícolas, una de las cuales valora sus activos biológicos a CH y la otra a VR. No se encontraron diferencias significativas en los beneficios e ingresos entre ambas muestras, ni siquiera en sus volatilidades. Tampoco se encontraron diferencias significativas en rentabilidad, manipulación contable, ni en el poder de ambos criterios de valoración para predecir los flujos de tesorería. Por el contrario, la mayor parte de los tests realizados revelan un mayor poder de los beneficios calculados bajo el VR para la predicción de los beneficios futuros, respecto de cuando son calculados bajo el CH. El estudio proporciona también evidencia empírica de prácticas contables defectuosas de CH en el sector agrícola, concluyendo que el VR puede representar un criterio de valoración interesante para un sector, como el agrícola, caracterizado por el predominio de pequeñas explotaciones familiares.

Fair value versus historic cost-valuation for biological assets: Implications for the quality of financial information

[spa] Este trabajo realiza un estudio empírico sobre los efectos, que se señalan en las discusiones teóricas, de la utilización del valor razonable (VR) frente al coste histórico (CH), utilizando dos muestras de explotaciones agrícolas, una de las cuales valora sus activos biológicos a CH y la otra a VR. No se encontraron diferencias significativas en los beneficios e ingresos entre ambas muestras, ni siquiera en sus volatilidades. Tampoco se encontraron diferencias significativas en rentabilidad, manipulación contable, ni en el poder de ambos criterios de valoración para predecir los flujos de tesorería. Por el contrario, la mayor parte de los tests realizados revelan un mayor poder de los beneficios calculados bajo el VR para la predicción de los beneficios futuros, respecto de cuando son calculados bajo el CH. El estudio proporciona también evidencia empírica de prácticas contables defectuosas de CH en el sector agrícola, concluyendo que el VR puede representar un criterio de valoración interesante para un sector, como el agrícola, caracterizado por el predominio de pequeñas explotaciones familiares.

Fair value versus historical cost-based valuation for biological assets: Predictability of financial information

There is an intense debate on the convenience of moving from historical cost (HC) toward the fair value (FV) principle. The debate and academic research is usually concerned with financial instruments, but the IAS 41 requirement of fair valuation for biological assets brings it into the agricultural domain. This paper performs an empirical study with a sample of Spanish farms valuing biological assets at HC and a sample applying FV, finding no significant differences between both valuation methods to assess future cash flows. However, most tests reveal more predictive power of future earnings under fair valuation of biological assets, which is not explained by differences in volatility of earnings and profitability. The study also evidences the existence of flawed HC accounting practices for biological assets in agriculture, which suggests scarce information content of this valuation method in the predominant small business units existing in the agricultural sector in advanced Western countries

The Present State and a Development Plan of Cost Accounting in Batch Production of Wind Turbine Gears

The aim of this master’s thesis was to document the present state and to create a development plan for Moventas Wind’s cost accounting. The current cost accounting system was evaluated and most fundamental problems were chosen as areas of focus in development work. The development plan includes both short- and long-term development proposals for problems identified. This report presents two alternative models for product costing. Benchmarking of cost accounting practices and modern cost accounting theories were used in development of cost accounting. It was found that the current cost accounting system functions quite well and the adjustments in unit cost rate calculation have only a minor influence on costs of goods sold. An OEE-based standard cycle concept was also developed and it was found that the implementation of this new system is worthwhile in the long-term.

Cost Optimisation of Mobile Advertising Client Data Transfer

Data traffic caused by mobile advertising client software when it is communicating with the network server can be a pain point for many application developers who are considering advertising-funded application distribution, since the cost of the data transfer might scare their users away from using the applications. For the thesis project, a simulation environment was built to mimic the real client-server solution for measuring the data transfer over varying types of connections with different usage scenarios. For optimising data transfer, a few general-purpose compressors and XML-specific compressors were tried for compressing the XML data, and a few protocol optimisations were implemented. For optimising the cost, cache usage was improved and pre-loading was enhanced to use free connections to load the data. The data traffic structure and the various optimisations were analysed, and it was found that the cache usage and pre-loading should be enhanced and that the protocol should be changed, with report aggregation and compression using WBXML or gzip.

EU-15 sovereign governments’ cost of borrowing after seven years of monetary union

Yield spreads over 10-year German government securities of the EU-15 countries converged dramatically in the seven years after the beginning of Monetary Integration. In this paper, we investigate the relative influence of systemic and idiosyncratic risk factors on their behaviour. Our conclusions suggest that in EMU-countries the relative importance of domestic risk factors (both credit and liquidity risk factors) is higher than that of international factors, which appear to play a secondary but significant role in non-EMU countries.

Does human capital stimulate investment in physical capital? Evidence from a cost system framework

The direct effect of human capital on economic growth has been widely analysed in the economic literature. This paper, however, focuses on its indirect effect as a stimulus for private investment in physical capital. The methodological framework used is the duality theory, estimating a cost system aggregated with human capital. Empirical evidence is given for Spain for the period 1980-2000. We provide evidence on the indirect effect of human capital in making private capital investment more attractive. Among the main explanations for this process, we observe that higher worker skill levels enable higher returns to be extracted from investment in physical capital.

A comparative study of difficulties in accounting preparation and judgement in agriculture using fair value and historical cost accounting for biological assets valuation

This paper presents empirical research comparing the accounting difficulties that arise from the use of two valuation methods for biological assets, fair value (FV) and historical cost (HC) accounting, in the agricultural sector. It also compares how reliable each valuation method is in the decision-making process of agents within the sector. By conducting an experiment with students, farmers, and accountants operating in the agricultural sector, we find that they have more difficulties, make larger miscalculations and make poorer judgements with HC accounting than with FV accounting. In-depth interviews uncover flawed accounting practices in the agricultural sector in Spain in order to meet HC accounting requirements. Given the complexities of cost calculation for biological assets and the predominance of small family business units in advanced Western countries, the study concludes that accounting can be more easily applied in the agricultural sector under FV than HC accounting, and that HC conveys a less accurate grasp of the real situation of a farm.