PDF superior The Sources of Quality in the Pharmaceutical Industry

In the second part, theoretical concepts from the first part are applied to the case study of laboratories operating in Argentina. The eight dimensions are utilized in order to classify, by the quality of its products, several laboratories (named 1, 2 ,3, and 4); it is observed that there is no perfect parallelism in rankings along all dimensions. This lack of parallelism reveals the existence of different managerial priorities or types of resources, and suggests different sources of quality as well as different business strategies among laboratories. In addition, it also reveals that the study of pharmaceutical product quality is even more complex when a modern, wide perspective of quality is adopted. Modern perspectives on quality go beyond its basic concept iv , incorporating organizational arrays, aesthetics concepts and quality of service to the client. Through general surveys, detailed interviews, visits to plants and the examination of relevant documents, the way that management systems and other enterprise assets such as technology contribute to create quality in the different dimensions of a pharmaceutical product are studied. In concrete cases, quality sources are identified.

In this paper, the evaluation of the investment project in research and development for the innovation and of great impact in the pharmaceutical industry is presented. The project evaluation is done through an American type real call option, based on binomial trees incorporating the expected volatility of the expected cash flows in order to determine the benefit of postponing the project three years, providing flexibility to investors in their decision making. Besides, in the valuation of a real option associated with the project, fuzzy sets theory is incorporated in the process of assigning possibilities to the branches of a tree. The value of the American type real call option to postpone the project are between 24.83 % and 51.22% of the investment, and the value of real option, using fuzzy logic is between 9.91% and 23.13% of the investment in a pessimistic scenario, and of the 10.04% and 39.08% of investment in an optimistic scenario, and for a experts scenario the option premium is between 10.00% and 26.91% of the investment, these are better results.

Abstract: It is common to find Competitive Intelligence activities within the high- tech enterpnses in particular in the pharmaceutical industry. These companies not only use the process of Competitive Intelligence (CI) to act against competitors, traditional aim of the CI. It is increasingly used to enhance cooperation. The cycle of CI is used both as to extract offensive and defensive intelligence as cooperative intelligence. The paper presents the results of a sample study of 186 Spanish pharmaceutical companies that were asked about the purpose of cooperation in their CI activities. The results confirm that these are used in the development of business relationships, search for partners, joint research, etc. and that companies bet on these relationships for the future within the CI.

The third argument is that drug companies are today, in many countries, the only accessible source of financial support for drug trials, the organization of large scien- tific meetings and CME events, so that it is practically unavoidable for a professional who wants to implement one of those activities to look for the support of the in- dustry. This is most probably true. However, again, the fact that a partnership is unavoidable does not imply that such a partnership should not have rules. The fourth argument is that the relationship with drug companies is not the only source of financial conflicts of interests for physicians and researchers, although it is by large the most visible. This is certainly a good point. There are indeed financial conflicts of interests in psychiatric practice and research which do not involve the pharmaceutical industry. For instance, public health sponsors usually have an interest to avoid spending money on the most expensive drugs(25). This may affect the conduct and the outcome of the studies they fund (e.g., comparisons between old- and new-generation drugs), especially if the report of re- sults in line with the public sponsor’s interest involves a better chance for researchers to be funded again by that sponsor.

It is common to find Competitive Intelligence activities within the high-tech enterprises in particular in the pharmaceutical industry. These companies not only use the process of Competitive Intelligence to act against competitors, traditional aim of the Competitive Intelligence. It is increasingly used to enhance cooperation. The Cycle of Competitive Intelligence (Cl) is used both as to extract offensive and defensive intelligence as cooperative intelligence. The paper presents the results of a sample study of 186 Spanish pharmaceutical companies that were asked about the purpose of cooperation in their Competitive Intelligence activities. The results confirm that these are used in the development of business relationships, search for partners, joint research, etc. and that companies bet on these relationships for the future within the Competitive Intelligence.

For the computation of the final gross electricity production two sources have been consulted. First, REE was used to import final electricity demand, imports, exports, and pumping consumption, which accounts for the energy consumed by pumping uphill water that will be driven to the turbine to produce electricity during peak-load hours (higher prices). The second source is IDAE; this one was useful to collect data concerning the auto-production and the power plants’ self-consumption. The Spanish TSO makes public the final demand at the power plants’ busbars; in other words, the energy that will be carried to the final points of consumption. This demand does not take into account the possibility that there are some heavy industries that demands such big amount of energy that they have their own power plant for their own and private use. Usually, the plant is next to the industry; hence, the network connecting generation point and consumption point does not affect the rest of the grid and cause any problem to REE. For this reason, REE does not consider that generation, or demand, in their publications.

As a first comment regarding these data, it is observed that the type of source is highly related to the mark given for the translation (corr = -0.492 / p = 0.000), i.e. in general terms, the more specialized sources, the higher the quality the target text will be. The negative sign confirms that the quality of the target term is indeed related to the source type and, moreover, to the order of the documentation sources previously foreseen in the hypothesis (regarding the reliability of use for the specialized translation): the texts whose terminology was searched for within bilingual texts have obtained a better mark than those searched for within documentation databases, and these last have a better mark that the ones searched within the terminology databases. On the other hand, the quality of the text is also related to the quantity obtained in the RV (corr = -0.236 / p = 0.005), which proves the uti-

A wide range of Pharmaceuticals and Personal Care Products (PPCPs) are present in the environment, and many of their adverse effects are unknown. The emergence of new compounds or changes in regulations have led to dynamical studies of occurrence, impact and treatment, which consider geographical areas and trends in consumption and innovation in the pharmaceutical industry. A Quantitative study of StructureeActivity Relationship ((Q)SAR) was performed to assess the possible adverse effects of ninety six PPCPs and metabolites with negligible experimental data and establish a ranking of concern, which was supported by the EPA EPI SuiteÔ interface. The environmental and toxicological indexes, the persistence (P), the bioaccumulation (B), the toxicity (T) (extensive) and the occurrence in Spanish aquatic environments (O) (intensive) were evaluated. The most hazardous characteristics in the largest number of compounds were generated by the P index, followed by the T and B indexes. A high number of metabolites has a concern score equal to or greater than their parent compounds. Three PBT and OPBT rankings of concern were proposed using the total and partial ranking method (supported by a Hasse diagram) by the Decision Analysis by Ranking Techniques (DART) tool, which was recently recommended by the European Commission. An analysis of the sensibility of the relative weights of these indexes has been conducted. Hormones, antidepressants (and their metabolites), blood lipid regulators and all of the personal care products considered in this study were at the highest levels of risk according to the PBT and OPBT total rankings. Furthermore, when the OPBT partial ranking was performed, X-ray contrast media, H 2 blockers and some antibiotics were included at the highest level of concern. It is important to improve and incorporate useful indexes for the predicted environmental impact of PPCPs and metabolites and thus focus experimental analysis on the compounds that require urgent attention.

To summarise, we found that the main processes underlying quality management are planning, improvement and control processes.Theories like Juran trilogy, 12 Deming points, Kaizen theory, six sigma, circles of quality, TQM, TOC, and so on, have in common the objective of improve quality based in the compliance of customers requirements and necessities, each method is different from the other and companies can combine or use just one of them. In the food industry due to the existence of obligatory quality management systems (GMP, GHP, HACCP), it could be recommended the combination of three theories, Juran’s trilogy because of its relation with HACCP, Kaizen theory because it's important to improve quality in every process with small steps but incremental ones, and Ishikawa theories regarding to suppliers quality management, because as we described before, quality of a final product has to be managed through the supply chain.

3 The pharmaceutical industry is the branch of the chemical sector devoted to the development, fabrication and commercialization of drugs with therapeutic value. Active pharmaceuticals ingredients (APIs) may be fabricated by different processes such as extraction from natural biomasses (fermentation or natural extraction), synthesis via organic reactions or a combination thereof. Subsequently, the API is formulated with different excipients to obtain the commercial drug. Today, most of the APIs are fabricated by chemical synthesis in plants working under batch. Typically, the fabrication of a single API comprises various intermediate stages and plants fabricate more than one API at the same time. With this diversity of processes, comes a similarly diverse set of wastes, including wastewater. The wastewater generated in chemical synthesis pharmaceutical plants is generally toxic and poorly biodegradable, containing a wide range of inorganic and organic (mostly solvents) pollutants. The composition is quite heterogeneous and varies from one day to another, as a function of the production schedule. This complexity hinders the adequate management of those wastes.

Quality perceived by outpatients in the SPhCHOC was evaluated every year of the study through a satisfaction survey (Figure 1). Through stratified random sampling, the necessary sample size was calculated with 95% certainty, a 30% loss rate, and ±6% accuracy for the entire hospital. A comparison of mean values was conducted for each year, in the variables of organization, pharmaceutical care, and overall sa- tisfaction level of the outpatient during the years of the survey, through Student’s t statistics, with a 95% confidence interval and for equal va- riances, using descriptive statistics calculation with the Epidat 4.2 com- puter program.

Research was done with the objective of evaluating the quality of the water supplied to the potable water system in Hidalgo Del Parral, which comes from two main supply sources: wells from Valle del Verano, which provide water to the east side of the city, and the Water Treatment Plant, which receives water from different mines and supplies the west side of the city. When this plant is overcome on its capacity of treatment, a part of the water from the mines is fed directly to the northwest part of the city. The metals lead (Pb), chromium (Cr), cadmium (Cd), zinc (Zn), and arsenic (As) were analyzed by atomic absorption (AA) technique, based in the United States Environmental Protection Agency (EPA) Method 7000B (Revision 2, February 2007). The digestion process was done according to the guidelines established in Method NMX-AA-051- SCFI-2001, Analysis of Water-Determination of Metals by Atomic Absorption, developed by the National Standardization Technical Committee for Environmental Protection (Mexico). The samples were collected from the following points: 13 wells and 2 re-pumping stations of Valle del Verano, the inlet and outlet of the Water Treatment Plant and domestic faucets. The east side of the city, supplied by the wells of El Verano, is metal-pollution free. The water that comes from the mines contains high concentrations of As, Zn, Cd and Pb, with levels that can get to 0.12, 32.6, 0.26 and 3.5 mg/L, respectively. This water pollution generated by mining can be

The control of degradation products is currently a critical issue to the pharmaceutical industry. A degradation product that appeared in alprazolam tablets during their sta- bility assay, 7-chloro-1-methyl-5-phenyl-[1,2,4]triazolo[4,3-a]quinolin-4-amine, also named triazolaminoquinoline, was tested as possible candidate in the HPLC method employed for the study. The impurity showed the same retention time and spectra as the degradation product; but as all these compounds are very closely related, a con- firmation with an independent technique was necessary, and CE was chosen for that purpose. Problems related to the adsorption of the analytes to the negatively charged silica surface were solved by employing a new polymeric capillary coating consisting of poly(3-aminopropylmethylsiloxane). The polymer provided EOF towards the anode, and the two compounds were separated in less than 8 min in a 60 cm total-length capillary, 75 mm id capillary with a BGE containing 50 mM phosphate buffer at pH 2.0 with 20% ACN. When the sample containing the degradation product was injected, the presence of triazolaminoquinoline was confirmed.

The construct of emotions is often confused with other constructs related to it such as mood, affect and attitude. The different constructs need to be distinguished first. The construct of affect is seen as the broad construct in describing the common state of feelings (Ali, Amin & Cobanoglu, 2016; Burns & Neisner, 2006; Krampf, Ueltschy & Amico, 2003). Some researchers establish a fine distinction between emotions and moods (Krampf et al., 2003). Such researchers associate emotions with action tendencies and describe emotions as a stronger turn-on than moods. In order to further distinguish the construct, Clore, Wyer, Dienes, Gasper, Gohm and Isbell (2001) and Frijda (1993) have regarded moods as generally non-intentional while emotions as typically intentional. The distinction between emotions and attitudes is also suggested by other researchers since emotions represent a more diverse and richer field of phenomenological experience. Krampf et al. (2003) further propose that emotions experience cannot be stored for a long time and then retrieved, as compared to attitudes. Burns and Neisner (2006) and Krampf et al. (2003) have defined emotions by referring to James (1890) whose work is considered as the basis of studying emotions in the early 19th century. During that time, emotions were considered as being complex, involving different patterns of stimulation. Schachter and Singer (1962) similarly viewed emotions through a cognitive appraisal process, as the general state of arousal. Bagozzi, Gopinath and Nyer (1999) however provided a broader definition where they described emotions as being “a mental state of readiness that arises from cognitive appraisals of an events or thoughts; has a phenomenological tone; is accompanied by physiological processes; was often expressed physically; and may result in specific actions to affirm or cope with the emotion, depending on its nature and the person having it.”

Our analysis of this real investment case provides new evidence about the relevance of sources of value which differ from direct cash flow. T he economies of scale present in the mobile telecommunicatins industry allow a new entrant in the market to consider the option to sell its customers base to larger players if it does not reach its business targets, because they are able to extract more value from the same customer base. To estimate the value of the option to abandon the industry, we apply the proposal of Copeland and Antikarov (2001), which is adapted to the nature of the investment analysed. One of the most important parameters in the valuation of the option is the strike price. Again, due to the economies of scale present in the industry, the strike price of the option to abandon can be calculated using the incremental NPV caused by higher EBITDA margins. This is a relevant point in the valuation and is a distinguishing element vs. traditional methods were the abandonment value did not change during the life of the project .

The reactions of professionals and students in face of gifts provided by the pharmaceutical and medical instrumentation industry include a spectrum of positions, from the minimization of the impact of institutional gifts on the professional(28), the recognition of benefits from relationships with the pharmaceutical industry such as support for the organization and the attendance to scientific events(44), the valuation of the medical sales representative as an intermediary agent between the health professional and new medications (29), the danger to the professional’s objectivity(9), to the professional’s reliability in face of the society which he serves(12,26). It is also stated that the influence of the pharmaceutical industry reaches patients associations, which are supported by them(11). The risk of disease commodification or mongering, basically consisting in promoting awareness with respect to illnesses and the “need” for medications to improve health conditions(22), is also discussed. The phenomenon is observed, for example, in potentially over-diagnosed cases, such as attention deficit disorders and depression. Another example is breastmilk replacement with substitutes(23).

Hence, this strong brand loyalty has made physicians gain experience with the drug under the period of patent exclusivity, making them insensitive to lower price opportunities. A Dutch study (de Wolf 1988) interviewing 200 prescribing physicians shows their reluctance to switch to generics since generic goods were badly represented in the doctor’s preferred set of drug names. Secondly, and from the point of view of the consumer purchasing drugs at the retail pharmacy, they usually lack the knowledge to evaluate the alternatives to branded goods. This effect is reinforced with wholesalers and pharmacists who have greater incentives to sell more expensive drugs, specially when pharmacies charge a fixed percentage margin by product sold. This percentage, given a base retail price of 100, ranges from 22.0 in the UK to 28.2 in Spain and 29.0 in France (NERA 1997). This is in contrast to the USA, where Masson and Steiner (1985) provide evidence that generic products usually carry higher gross margins to pharmacists which implies that both the consumer and the pharmacist will be willing to substitute. This difference could be another reason which could explain Table 1.

With the 1962 amendment to the “Food, Drug and Cosmetic Act,” re- searchers found it necessary to discuss the determinants of inventions in this sector to determine the true impact of the amendment in the structure of pharmaceutical innovations. Among the structural factors that affect research and development, the literature stresses market size, past cash flow of firms, and research productivity. Peltzman (1973) provided a simple model that explained the introduction of drugs as a function of lagged market size. Using a time-series analysis over the period 1948–1962 (annual data), he found a strong positive effect of market size over the introduction of drugs. In his analysis, the 1962 amendment would have had a significant and negative impact over drugs introduced after 1962. Vernon and Gusen (1974) related the introduction of new chemical entities (new drugs) with the size of the firm—rather than the size of the market—and they found that a larger firm would, holding everything constant, introduce more drugs.

Aware that Jesus has become a celebrity and his deeds a recurrent topic of conversation, Mary remains skeptical, commenting that “for those who gathered and gossiped it was a high time, filled with rumours and fresh news, filled with stories both true and wildly exaggerated” (56). This illustrates that her son’s miracles are but a secondary issue for her. What matters to Mary is that she is being pointed at, her house marked, her privacy invaded. Since people recognise her only as the mother of Jesus, Mary strains to reclaim a life and identity of her own. As Edward Hagan explains, “Tóibín’s mothers […] desire their personal freedom to pursue their own goals”, despite the fact that “they live in the ‘other’ world of isolation and anonymity” (2012: 34). In The Testament of Mary, the protagonist’s world of isolation seems to be her house in Ephesus, where she lives alone in exile and depends on the care of her guardians. Moreover, another revealing moment in this novel takes place in Nazareth when Marcus warns Mary about her need to avoid being publicly seen lest she be arrested. Asserting her personal independence, Mary curtly answers: “I am not one of his followers” (58). Significantly, whereas the official story of the Virgin is interwoven within the narrative of Jesus’s divinity, Tóibín’s Mary would like to separate herself from it. Mary, as the mother of Jesus but not as the Holy Mother or Mother of God, seeks empowerment by trying to distance herself from her son’s influence.

In fact, the novel's use of Caddy as the absent element that always returns and that resists symbolisation confers on her (as popular culture text) the status of the real, at the same [r]