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This open access book presents a unique collection of practical examples from the field of pharma business management and research. It covers a wide range of topics such as: "Brexit and its Impact on pharmaceutical Law - Implications for Global Pharma Companies", "Implementation of Measures and Sustainable Actions to Improve Employee's Engagement", "Global Medical Clinical and Regulatory Affairs (GMCRA)", and "A Quality Management System for R&D Project and Portfolio Management in a Pharmaceutical Company".
The chapters are summaries of master’s theses by "high potential" Pharma MBA students from the Goethe Business School, Frankfurt/Main, Germany, with 8-10 years of work experience and are based on scientific know-how and real-world experience. The authors applied their interdisciplinary knowledge gained in 22 months of studies in the MBA program to selected practical themes drawn from their daily business.
Writing the history of archaeology has become increasingly diverse in recent years due to developments in the historiography of the sciences and the humanities. A move away from hagiography and presentations of scientific processes as an inevitable progression has been requested in this context. Historians of archaeology have begun to utilize approved and new historiographical concepts to trace how archaeological knowledge has been acquired as well as to reflect on the historical conditions and contexts in which knowledge has been generated. This volume seeks to contribute to this trend. By linking theories and models with case studies from the nineteenth and twentieth century, the authors illuminate implications of communication on archaeological knowledge and scrutinize routines of early archaeological practices. The usefulness of different approaches such as narratological concepts or the concepts of habitus is thus considered.
A richly illustrated guide to the dolmen culture of Prehistoric Sicily.
Scattered around the world in woods and on mountains dolmens have posed a mystery for hundreds of years. The interpretations of these mysteries has been extremely imaginative over the centuries.
But in Sicily it has only been in recent years that the presence of numerous megaliths habe been revealed.
This manual provides a comprehensive guide to the dolmens of Sicily and the artefacts as well as historical and cultural associations of these prehistoric sites.
The authors take a detailed look at the economic competence and financial literacy of young adults, especially of those who start an apprenticeship or who take up their studies at an university. Economic competence and financial literacy are of special interest within this group, because these young people are – mostly for the first time in their lives – responsible for autonomously managing their own financial affairs and deal with economic challenges.
Gegenstand dieser Dissertation war das Ermitteln der Verbesserung der peroralen Bioverfügbarkeit Fenofibrat (FFB) durch lipid-basierte Formulierung (LBF). Eine weitere Aufgabe bestand darin, verschiedene analytische Methoden zur Bewertung der Verbesserung der oralen Bioverfügbarkeit von Fenofibrat einzusetzen. Diese schlossen in vitro biorelevante Löslichkeits-, Dispersions-, Auflösungs- und Präzipitationstests ein. Auf Basis der analytischen Ergebnisse wurden dann PBPK-Modelle verwendet, um menschliche Plasmaprofile nach der Verabreichung der FFB-Formulierungen zu simulieren. Die daraus resultierenden in silico-Vorhersagen stimmten mit den in vivo-Beobachtungen überein. Durch Anwendung der Parametersensitivitätsanalyse war es weiterhin möglich, ein mechanistisches Verständnis der beteiligten geschwindigkeitsbegrenzenden Schritte zu erreichen.
Formulierungen auf Lipidbasis können nach dem Pouton-Klassifizierungssytem eingeteilt werden. Typ I Formulierungen bestehen ausschließlich aus Ölen, während am anderen Ende der Skala die Typ IV Formulierung weitestgehend aus Tensiden ist. In dieser Arbeit wurden in erster Linie Lipidformulierungen Typ IIIA und Typ IIIB untersucht.
Es wurde gezeigt, dass Dispersionstests an FFB-Lipidformulierungen am besten unter Verwendung der USP 3-Apparatur durchgeführt werden, da in diesem Apparat die GI-Motilität in vivo am besten reflektiert wird. Um die Hydrodynamik in verschiedenen Auflösungsapparaten zu vergleichen, wurde der Auflösungsversuch von LBF Nr. 1 – Nr. 4 von FFB auch unter Verwendung von USP 2 durchgeführt. Ungeachtet von kompendialen oder biorelevanten Medien führten die meisten dieser Lipidformulierungen zur Auflösung eines Großteils des beladenen Medikaments, im Gegensatz zum unformulierten Fenofibrat, das sich in nüchternem Zustand kaum auflöst. Weiter zeigten die Transfermodellexperimente an den Lipidformulierungen von FFB, dass eine intestinale Präzipitation nach einer Magenauflösung unwahrscheinlich ist.
Durch mathematische Transformation der Noyes-Whitney-Gleichung kann ein Excel-Toolkit zur Berechnung des z-Werts aus in-vitro-Auflösungsprofilen verwendet werden. Die z-Werte werden dann in physiologisch-basierte pharmakokinetische in silico Modelle, STELLA® und Simcyp®, eingesetzt. Anhand der erforderlichen post-absorptiven Parameter kann mithilfe dieser Modelle die Plasma-Arzneistoff-Konzentration nach oraler Verabreichung von verschiedenen Formulierungen vorhergesagt werden. Darüber hinaus ermöglicht der Simcyp®-Simulator eine Reihe von virtuellen Versuchen, die PK-Variabilität vom Wirkstoff in verschiedenen Bevölkerungsgruppen zu bestimmen. Um diese Möglichkeiten für LBF von Fenofibrat zu testen, wurde LBF Nr. 4 modelliert. Das Simulationsergebnis von Simcyp® entsprach dem aus der STELLA®-Software. Weiterhin wurden die Plasmafenofibrinsäure-Konzentrationsprofile von den Modellen genau vorhergesagt. Die Punktschätzwerte für Cmax und AUC, berechnet aus den In-silico und in vivo Plasmaprofilen, lagen sogar im Bereich von 0,8-1,25 für die SMEDDS Lösung und Kapselformulierungen. Diese Übereinstimmung von in vitro-in silico mit in vivo wurde weiterhin durch Berechnung der jeweiligen f2 Faktoren unterstützt.
Basierend auf diesen Ergebnissen scheint es, dass der In-vitro-In-Silico-In-vivo-Ansatz ein nützliches Werkzeug zum Identifizieren und Vergleichen von Beschränkungen der oralen Absorption für Formulierungen auf Lipidbasis und zum Optimieren der Lipidformulierungsentwicklung von schlecht löslichen Arzneimitteln darstellt.
The are three groups of islands in the Indian Ocean east of Africa, which are very different regarding their size, elevation, geological age and number of mosses and liverworts. Mauritius is situated 900 km E of Madagascar on 21°S and consists of volcanic rocks which originated about 8 million years ago. The island is relatively small, about 60 km from W to E and 80 km from N to S, and also relatively low with only a few mountains reaching 800 m altitude. Due to massive habitat destruction and deforestation, the natural forest is almost totally destroyed. Already Renauld (1897) stated "l'extension des cultures a forcément diminué la richesse de la vegetation spontanée". The lower altitudes are almost totally converted to sugar cane plantations. The largest semi-natural part of the island is the Black River National Park in the SW of the island, a high plateau with partial swampy forests, which is eroded by deep gorges. The SE flanks face the wind clouds and receive precipitation of up to 4000 mm or more. The NW parts are distinctly drier, particularly the higher mountains in the NW part of the Island (Le Pouce and Pieter Botha). The vegetation in the higher parts consists of a secondary growth of Sideroxylon bush which is partially forested with Pinus and Eucalyptus. A bryophyte flora of Mauritius was published by Tixier & Guého (1997), which is unfortunately no more available. The moss flora was treated by Frahm et al. (2009) and Een (2009). It consists of 238 species, as compared with 158 species of liverworts included in the checklist of the East African Island by Grolle (1995), updated by Wigginton (2009). (For comparison: Madagascar has 372, Réunion 260, Rodriguez 27, the Seychelles 108, the Comores 143 liverwort species). Réunion is situated 170 km E of Mauritius at the same latitude (between 20° and 21°S). It is with 2511 km2 only slightly larger as Mauritius but with 3069 m much higher. It is with 2 mya also much younger than Mauritius. Due to the steepness, natural habitats in the interior of the island are in a good state of conservation with the only exception of the coastal and lowland regions, which are densely populated. A checklist of the mosses and liverworts of Réunion was published by Ah-Peng & Bardat (2005), additional notes on the mosses by Frahm (2010). Mauritius and Réunion are comprised as the Mascarenes Islands. Further north are the Seychelles, which reach 4° S and thus almost the equator. They consists of 115 Islands, which are dispersed within 400.00 m2 in the Indian Ocean north of Réunion and Mauritius. They are usually divided into the Inner and Outer Islands. The Outer Islands comprise of the Amirantes; Alphonses; Farquhar Islands and Aldabra Islands. Only six species of mosses are known from some of the Aldabra Islands. The Inner Islands consists of 42 granitic islands and two coral islands (Bird Island, Denis Island). The granitic islands are part of the former Gondwana continent and have never been submerged during their geological history. After the split of the Gondwana continent, the Seychelles remained attached to India until 65 mya. Amongst the granitic islands, Mahé, Praslin, Silhoutte and La Digue are the largest and the most visited ones by bryologists, the others are much smaller.
The mediterranean vegetation is determined by a seasonal climate with hot and dry summers and cold and rainy winters. These contrasting seasons determine much the bryopohyte flora
by the way that part of the species are winter annual and show up only during the rainy seasons but diasappear over the summer. Therefore the best season for observing and collecting
bryophytes are the months January to March or April. As a consequence, a high percentage of mosses and liverworts are winter ephemerals, finishing its live cycle within two months such as many acrocarpous mosses, or „oversummer“ the dry period in dry state almost not visible such as many thalloid liverworts. This counts for the true mediterranean vegetation, which is found in the coastal areas around the Mediterranean Sea up to some hundred meters altitude, which is focussed in this books. The mountain areas as well as the temperate forests show a more temperate flora. Therefore the bryoflora of the higher regions is similar to that of Central Europe is is not concerned. Aim of this book is not to give an academic seminar on the ecology, altitudinal zonation, regional biodiversity or structural adaptation of mediterranean bryophytes nor to give
bibliographies for regional or complete (there is only one for liverworts) checklists or books for identifications but an illustrated guide to the mosses and liverworts of the Mediterranean with some comments on the species.
Cross-border exchange and comparison of forensic DNA data in the context of the Prüm decision
(2018)
This study, commissioned by the European Parliament’s Policy Department for Citizens’ Rights and Constitutional Affairs at the request of the LIBE Committee, provides an overview of the Prüm regime. It first considers the background of the Prüm Convention and Prüm Decision. The subsequent two chapters summarize the Prüm regime in relation mainly to DNA data looking at value and shortcomings; and ethical, legal and social implications of forensic DNA typing and databasing in relation to the Prüm regime. Finally, based on the analysis, it provides the policy recommendations.
The Institute for Monetary and Financial Stability (IMFS) is a research center of the Johann Wolfgang Goethe University, Frankfurt am Main, located in the "House of Finance". The Institute was established as implementation of the project "Currency and Financial Stability" funded by a grant of the Stiftung Geld und Währung (Foundation of Monetary and Financial Stability). The Foundation of Monetary and Financial Stability was created January 1, 2002 by federal law. ...
The present study focuses on the Benthic Macroinvertebrate Fauna of natural running waters and semi-natural stagnant waters of Himalayan region and Lowlands in the Ganges River Basin. Habitat quality assessment using three different biotic scores was applied for 32 sampling sites of running waters and 26 sampling sites of stagnant waters. Benthic Macroinvertebrates were used as bio-indicators. Calculation of water quality was done based on a recently established five-class system, to describe the degree of organic pollution. Sampling localities are covering all longitudinal biocoenotic zones and lateral zones to include the traditionally well defined types of running and stagnant waters of altitudinal range from 54- to 2480 m asl. The impact of natural organic load was studied to describe the variation of Ecological quality classes within different eco-regions. Ecological quality was defined as a result of the water quality class together with the eco-morphology status of the water body. Class I (Excellent) is present only in spring-near headwaters of forested areas or in running waters coming from higher elevations between 490 to 2500 m asl. Class II (Good) and III (Moderate) is the normal reference condition for lowlands and the Gangetic plains. Wetlands, oxbow-lakes and "old" ponds have usually class II or III, independent from the grade of forests due to natural organic load accumulated during monsoon flood. Water quality undergoes seasonal changes from III (moderate) in pre-monsoon to II (good) during and after monsoon. The highest diversity with >30-42 identified taxa per sampling site (Class I) was found in the Rhithron zone of densely forested parts of Nepal, followed with >20-30 identified taxa by the Metapotamon zone (Class II, III) of large rivers in the Gangetic Plains of India. In stagnant water bodies the maximum diversity reaches >30-76 identified taxa (Class II, III) in Nepal and Maharashtra between 197-1170 m asl, whereas the floodplain wetland diversity reaches only 27 taxa (Class III). The proposed use of selected Insect-groups as bio-indicators for Lowlands and Middle Mountains includes colored illustrated catalogue of Dragonflies (Odonata), Bugs (Heteroptera), and Cockroaches (Blattodea). 12 families with 31 taxa of Odonata Nymphs, 14 families with 27 taxa of Heteroptera Nymphs and Adults, one family with two taxa of Blattodea Nymphs and Adults are described and figured with identification characters and ecological habitat observations. This will be the first key based on material mainly from Nepal and India for the Ganges River Basin.
Historically – if one can say that given the infancy of the field – environmental plastic debris has been the baby of marine research. Driven by the rediscovery of long forgotten, 1970s studies on the occurrence of small plastic fragments (today termed microplastics) in the oceans, oceanographers and marine biologists resurrected the topic in the early 2000s. Since then, the field has rapidly expanded and established that plastics are ubiquitous in the marine system, from the Arctic to Antarctic and from the surface to the deep sea. ...
The research reported in this thesis examines two main questions: firstly, which dictionary type, bilingual or monolingual, is most effective for intermediate learners of German for reading comprehension, and secondly, which features make monolingual dictionary definitions effective for these learners. These questions divide the thesis into two parts. The first part compares the effectiveness of the bilingual versus the monolingual dictionary, and the second part compares two different monolingual definition styles.
The research was originally motivated by the observation that Hong Kong Chinese intermediate learners of German prefer to use a German-English bilingual dictionary. Since the translations are presented in the learners' second language, the effectiveness of this bilingual dictionary is doubtful. On the other hand, the learners are reluctant to use the monolingual dictionary, recommended to them by their language teachers. Three investigations were conducted in order to gain more detailed knowledge about the learners' dictionary preference, and the effectiveness of the two dictionary types. The learners' dictionary preference was investigated by means of a survey of ninety-eight foreign language students. The effectiveness of the bilingual and monolingual dictionary for reading comprehension and incidental vocabulary learning was first measured experimentally. The think-aloud method was then used in order to discover factors which determine the effectiveness of the two dictionary types.
The results of the experiment revealed that the German-English bilingual dictionary was not significantly more effective for the learners than the monolingual dictionary. The only monolingual dictionary available for German at that time, however, is linguistically too difficult for this proficiency level. Because of these findings, the research turned to monolingual dictionary definitions with the aim of identifying features that make them accessible to intermediate learners. Based on findings from the first think-aloud study, and principles promoted as user-friendly in the lexicographic literature, new definitions were developed for the target words in the research. These new definitions were compared with those in the existing dictionary. A second think-aloud study was conducted in order to generate hypotheses about individual definition features. These hypotheses were then tested in the second experiment, which was conducted with eighty-six learners of German in Shanghai.
The investigations reveal several features that determine the effectiveness of monolingual definitions for intermediate learners. The findings have theoretical and pedagogical implications. In the theoretical field, some lexicographic principles were recommended that are, unlike previous principles, based on empirical insights into user needs. In the pedagogical field, the research findings provide an empirical basis for the evaluation and recommendation of suitable dictionaries to intermediate learners.
A model of dictionary effectiveness is proposed. This model could help to assess the effectiveness of different information categories in dictionaries for different proficiency levels and different activity contexts. It could also provide lexicographic principles for the design of dictionaries. This research contributes one component to the proposed model: criteria for the effectiveness of definition features for intermediate learners in the activity context of reading.
Be it in the case of opening a website, sending an email, or high-frequency trading, bits and bytes of information have to cross numerous nodes at which micro-decisions are made. These decisions concern the most efficient path through the network, the processing speed, or the priority of incoming data packets.
Despite their multifaceted nature, micro-decisions are a dimension of control and surveillance in the twenty-first century that has received little critical attention. They represent the smallest unit and the technical precondition of a contemporary network politics – and of our potential opposition to it. The current debates regarding net neutrality and Edward Snowden’s revelation of NSA surveillance are only the tip of the iceberg. What is at stake is nothing less than the future of the Internet as we know it.
European Music Portfolio (EMP) – Maths: 'Sounding ways into mathematics' : teacher’s handbook
(2016)
Music and mathematics share an odd character: many people believe that they are not good at one or the other (or both). However, ‘I cannot sing’ or ‘I never understood mathematics’ will probably not keep them from having successful careers, and nor will it change the opinions others have about them.
The project ‘European Music Portfolio – Sounding Ways into Mathematics’ (EMP-Maths) aims towards a different understanding with regards to this character. Everyone can sing and make music, and everyone can do mathematics. Both topics are integral parts of our life and society. What needs to be improved is our ability to give students opportunities to like them.
This teacher’s handbook presents activities with different mathematical and musical content in order to offer teachers resources, ideas and examples. These activities are designed to be expandable, adaptable to different contexts, and adjustable to the needs of each teacher and their students. Furthermore, these activities are not just planned to be carried out individually; a teaching unit could be used to make sense of them, or they could even be developed in connection with each other.
Apart from this teacher’s handbook, the project provides a continuing professional development (CPD) course, a webpage (http://maths.emportfolio.eu) from which all materials can be downloaded, and an online collaboration platform. A general overview of related literature and research is available in separate documents. Additional teacher booklets provide related materials and a brief overview of the theoretical background, and are the basis for the CPD courses. The project ‘Sounding Ways into Mathematics’ is related to the EMP-Languages project ‘A Creative Way into Languages’ (http://emportfolio.eu/emp/).
Oral Literature in Africa
(2012)
This thesis investigates how students with Cantonese (L1) and English (L2) backgrounds acquire German as a third language (L3), with a focus on the acquisition of the Vorfeld (fronting) constructions of German. In L3 studies, the roles played by mother tongue, L2 and developmental grammar may be distinguished. Previous L3 studies have suggested that the role of L2 seems to be prominent in L3 strategy building, including interlanguage transfer from L2 to L3. Pursuing a cognitive approach, we argue that incremental production and language processing strategies are significant factors in accounting for third language acquisition and production.
A total of 45 university students of German completed a questionnaire and submitted copies of their compositions, followed by picture elicitation tasks. Three typical fronting types were found to be common amongst the learners:
1. Für mich, jede Familie hat eigene Situation und Probleme.
2. Obwohl gibt es viele Probleme mit alten Leuten zusammen lebt, finde ich gut dafür.
3. Jetzt die meisterns haben schon nach Hong Kong zurückgekommen.
Type 1 is argued to reflect indirect transfer of native language function-form characteristics. Type two is argued to be an intralingual error in which the learners have overgeneralized the verb second (V2) rule, without acquiring the correct function of the Vorfeld construction. The third type shows that apart from the influence of English in adverb fronting constructions, adverbs of stance or perspective adverbs like ‘jetzt’ semantically do not form part of the proposition and they are therefore treated as “extra-sentential” constituents which do not affect the basic V2 construction.
The findings suggest that learners may have primarily acquired the topic function of German fronting, while failing to fully acquire the focus function. For the focus function, learners seem to prefer alternative constructions such as existential sentences using ‘es gibt’. Both of these findings implicate L1 Chinese influence.
As an overall perspective on the incipient field of third language acquisition research I propose a holistic and coherent view which encompasses syntax, semantics and pragmatics at all levels of language development. By probing an independent paradigm of L3 studies, we aim to contribute to a new dynamic research space as well to ongoing debates in the SLA field by attributing greater autonomy and consciousness to the learner, even on the level of grammatical interaction.
I would like to start off my cultural-historical intervention with a trouvaille from the 'Denktagebuch', a sort of intellectual notebook, of Hannah Arendt, the famous German-Jewish philosopher (1906–1975). Arendt's publications include a most profound book on the 'Human Condition' (1958, in German 'Vita activa', 1960) in which she develops the idea of 'acting / Handlung' as the crucial realm of intersubjectivity and humanity. This realm is based in the space between human beings, a literal 'inter-est' of togetherness. It is only in this space, only in the relationship to others, that the full sense of the Self, including the involuntary expressions of the person, manifests itself. It is the same realm in which the moral, social and political life is created. In the notebook of the 44-year-old Arendt one comes across the following entry: "In nichts offenbart sich die eigentümliche Vieldeutigkeit der Sprache [...] deutlicher als in der Metapher. So habe ich zum Beispiel ein Leben lang die Metapher 'es öffnet sich mir das Herz' benutzt, ohne je die dazu gehörende physische Sensation erfahren zu haben. Erst seit ich die physische Sensation kenne, weiss ich, wie oft ich gelogen habe [...]. Wie aber hätte ich je die Wahrheit der physischen Sensation erfahren, wenn die Sprache mit ihrer Metapher mir nicht bereits eine Ahnung von der Bedeutsamkeit des Vorgangs gegeben hätte?" (Notebook II, 22 December 1950, Arendt 2002, 46) The entry discusses the mutual transferral between mind and body by reflecting the role of language as a mediator for minding the body and the embodiment of the mind. Since the phrase of the 'open heart' belongs to a register of long-established metaphors, these reflections concern the comprehension of body-metaphors and their role for a 'shared meaningful space of experiences' (Gallese 2009a, 527), i.e. language as transmitter of experiences and memory in cultural history.