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Magister Legum - LLM / South Africa

No description available.

No description available.

Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul - FAPERGS / The human parathyroid hormone (hPTH) is a polypeptide secreted by the parathyroid glands that is essential for the maintenance of the calcium ion homeostasis in the blood. The recombinant DNA technology has enabled the expression of hPTH gene in Escherichia coli, and thus the large-scale production of recombinant human parathyroid hormone (rhPTH 1-34), teriparatide, which contain the active amino-terminal fragment of the full length hPTH. The rhPTH is clinically used to treat osteoporosis at high risk of fractures in postmenopausal women, men with osteoporosis primary or hypogonadal and adults with glucocorticoid-induced osteoporosis (GIO). Cappilary zone electrophoresis (CZE) method was developed and validated for the assessment of rhPTH in biopharmaceutical formulations. The analysis for CZE method was performed on a fused-silica capillary (effective length, 40 cm; 50 μm i.d.), using electrolyte solution consisted of 50 mM dihydrogen phosphate solution at pH 3.0. The capillary was maintained at 25º C, the applied voltage was 20 kV. Injections were performed using a pressure mode at 50 mbar for 45 s, with detection by photodiode array detector set at 200 nm. Separation was obtained with a migration time of 5.3 min, and was linear over the concentration range of 0.25-250 μg mL-1 (r2 = 0.9992). The limits of detection and quantitation were 0.12 and 0.40 μg/mL, respectively. Specificity and stability-indicating capability were established in degradation studies, which also showed that there was no interference of the excipients. The accuracy was 100.28% with bias lower than 0.85%. Moreover, the in vitro cytotoxicity test of acidic, photolytic and thermal degradated forms showed significant differences (p<0.05) compared to intact molecule. The cell proliferation and alkaline phosphatase activity bioassays in UMR-106 cells were developed and applied to assess the biological activity of rhPTH in biopharmaceutical formulations The results of content/potency were correlated to those of the validated reversed-phase liquid chromatography (RP-LC), size-exclusion liquid chromatography (SE-LC) and CZE methods, showing significant correlation (p> 0.05) Thus, the application of the validated physico-chemical methods together with in vitro bioassays, was suggested to improve quality control of rhPTH biotechnology-derived product and to support studies of biosimilars. / O hormônio da paratireóide humano (hPTH) é um polipeptídeo produzido e secretado pelas glândulas paratireóides, e é fundamental para a manutenção da homeostase dos íons cálcio no sangue. A tecnologia do DNA recombinante possibilitou a expressão do gene do hPTH em Escherichia coli, e a produção em grande escala do hormônio da paratireóide humano recombinante (rhPTH 1-34), também denominado Teriparatida, o qual apresenta a sequência de aminoácidos responsável pela porção biologicamente ativa do paratôrmonio natural. O rhPTH é clinicamente indicado para o tratamento da osteoporose de alto risco de fraturas em mulheres pós-menopausa, de homens com osteoporose primária ou hipogonadal, e da osteoporose associada à terapia sistêmica com glicocorticóides. Neste trabalho foi desenvolvido e validado método por eletroforese capilar de zona (ECZ) para a avaliação de rhPTH em produtos biofarmacêuticos. No método por ECZ, utilizou-se capilar de sílica fundida (40 cm de comprimento efetivo x 50 μm d.i.) e solução eletrolítica composta de fosfato de sódio dihidrogenado 50 mM, pH 3,0. O capilar foi mantido a temperatura de 25ºC, e a tensão aplicada foi de 20 kV. O tempo de injeção foi de 45 s, com pressão de 50 mBar, e detecção por arranjo de diodos (DAD), em 200 nm. A separação eletroforética foi obtida com tempo de migração de 5,3 min, sendo linear na faixa de concentração de 0,25-250 μg/mL (r2 = 0,9992). Os limites de detecção e quantificação foram de 0,12 e 0,40 μg/mL, respectivamente. A especificidade foi avaliada através de análises com os excipientes da formulação biofarmacêutica e estudos de degradação, demonstrando a seletividade do método. A exatidão foi 100,28% com bias inferior a 0,85%. Além disso, realizou-se o teste de citotoxicidade in vitro das formas degradadas, apresentando, para as amostras submetidas às condições ácida, fotolítica e térmica, diferença significativa (p< 0,05) em relação à molécula íntegra. Os bioensaios de proliferação celular e da atividade da fosfatase alcalina em células UMR-106 foram desenvolvidos e aplicados para avaliação da atividade biológica de rhPTH em formulações biofarmacêuticas. Os resultados de teor/potência foram correlacionados com os métodos já validados por cromatografia líquida em fase reversa (CL-FR), cromatografia líquida por exclusão molecular (CL-EM) e ECZ, apresentando correlação significativa (p> 0,05). Assim, sugere-se que o métodos físico-químicos validados sejam aplicados paralelamente aos bioensaios in vitro para aprimorar o controle da qualidade do produto biotecnológico de rhPTH, e para avaliação da biossimilaridade de rhPTH.

L’œuvre de Tite-Live propose une histoire de la Res publica romaine depuis sa naissance jusqu’au tournant du premier siècle av. J.-C. où, selon les termes de l’auteur, « l’État se détruit sous l’effet de ses propres forces ». Au sortir d’une période de guerres civiles qui bouleversa en profondeur les repères politiques et sociaux, il s’agit pour l’historien de redéfinir l’identité politique de Rome en puisant dans les grands exemples du passé, à une époque où Auguste, en ramenant la paix, propose aussi, avec le Principat, un nouveau modèle d’exercice du pouvoir. Cette étude propose de relire l’Ab Vrbe condita comme une réflexion sur le pouvoir, un « discours », à une époque de profondes mutations. Retraçant le passé de la ville, l’historien exprime une pensée politique cohérente à travers ses commentaires, ses choix narratifs, et les discours qu’il attribue à différents personnages historiques. Celle-ci est le plus souvent proche de celle de Cicéron qui, du De Republica au De Officiis, offrait un cadre philosophique à la réflexion sur les institutions et les devoirs de l’homme d’État. Mais Tite-Live se la réapproprie en l’enrichissant des préoccupations politiques de son époque. Son récit de l’histoire de Rome s’inscrit principalement dans une défense de la libertas du peuple romain menacée par l’émergence d’un pouvoir personnel. Dans chaque situation, l’historien insiste sur les rapports complexes du dirigeant avec les institutions de la cité et le peuple de Rome. Par la mise en relation des exempla et des discours, Tite-Live propose un modèle de gouvernement unifié et cohérent fondé sur les vertus des dirigeants du passé et les valeurs collectives du peuple romain. / Livy’s body of work presents a history of the Roman Res publica from its beginnings to the turn of the first century. Civil wars had then deeply shaken the political and socials benchmarks and, while Augustus, after bringing peace back, was trying to impose a new political model with the Principate, it was the historian’s role to redefine Rome’s political identity through the use of well-known examples from the past. Livy’s From the Founding of the City may thus be read as a discourse about Roman power in a period of deep political change. The historian, as he tells the story of the city’s past, makes comments, narrative choices, and inserts into the historical figures’ speeches general remarks which help in many ways to grasp his political thinking. Most of the time, this thoughts are close to what can be read in Cicero’s political treatises. Cicero’s De Republica and De Officiis actually offered a philosophical frame of reference to political thinking, concerning the state institutions and the duties of state leaders. However, Livy develops his own theory and adds to Cicero’s political thought considerations on issues specific to his own time. Livy mainly defends the libertas of the Roman people against the emergence of personal power. In each and every situation, Livy sheds light on the complex relationships between the leaders and the state institutions and between the leaders and the Roman people. Linking exempla and speeches, Livy suggests a stable and coherent leadership model based upon the virtues of past political leaders and the collective principles of the Roman people.

Innerhalb der vorliegenden Arbeit wurden die gesundheitsrelevanten Charakteristika von Führung an Hochschulen aus Mitarbeiter- und Vorgesetztenperspektive untersucht. Auf Grundlage einer umfassenden einleitenden Betrachtung des Forschungsstandes zu den Themen Führung und Gesundheit, sowie der Betrachtung der Studienlage zu Führungsfaktoren an Hochschulen zeigt sich u.a., dass Vorgesetzte in vielerlei Hinsicht eine Schlüsselposition bei der Gesunderhaltung ihrer Mitarbeitenden einnehmen. Die theoretische Auseinandersetzung mit dem direkten und indirekten Führungseinfluss und den bestehenden Modellen zur gesundheitsförderlichen Führung ergab die Identifikation von intra- und interindividuellen Faktoren der Selbst- und Mitarbeiterführung. Zudem konnten vielfältige führungsseitige strukturelle und personelle Einflussmöglichkeiten im Hinblick auf die Arbeits- und Organisationsgestaltung und die Bereichskultur aufgezeigt werden. Innerhalb des empirischen Teils der Arbeit wurde das entwickelte Modell mittels verschiedener Analyseinstrumente der qualitativen Sozialforschung, einer schrittweisen induktiven Erweiterung und einer gleichzeitigen Spezifizierung für den Hochschulkontext unterzogen. Innerhalb des sich anschließenden Diskussionsteils wurden die Forschungsfragestellungen näher beleuchtet und methodische Limitationen erörtert. Die Arbeit schließt mit der Generierung von Implikationen für die Führungspraxis der hochschulbezogenen wissenschaftlichen und nicht-wissenschafflichen Bereiche.:1 Einleitung 2 Theoretischer Bezugsrahmen 3 Methodik 4 Ergebnisse 5 Diskussion 6 Schlussbetrachtungen 7 Anhang / In the present work, the health-related characteristics of leadership at universities were examined from the perspective of employees and superiors. Based on a comprehensive examination of the state of research on the topics of leadership and health, as well as management factors at universities, it has been shown that superiors play a key role in keeping their employees healthy in different ways. The theoretical examination of the direct and indirect influence of leadership and the existing models for health-promoting leadership resulted in the identification of intra- and inter-individual factors of self-leadership and employee leadership. In addition, it was also possible to identify a wide range of management-related structural and personnel influence options with regard to work and organizational design and culture within different areas of the university. Within the empirical part of the work, the developed model was subjected to a step-wise inductive expansion and a simultaneous specification for the university context using various analytical instruments of qualitative social research. In the subsequent discussion, the research questions are examined in more detail and methodological limitations are discussed. The work concludes with the generation of implications for management practice in university-related scientific and non-scientific areas.:1 Einleitung 2 Theoretischer Bezugsrahmen 3 Methodik 4 Ergebnisse 5 Diskussion 6 Schlussbetrachtungen 7 Anhang

Soziale Innovation – Sie gilt als Lebenselixier moderner Gesellschaften und wird im sozialen Miteinander doch wenig benannt. Politiker und Wissenschaftlicher sehen in ihr den Schlüssel der gesellschaftlichen Neuerung, die durch Bürgerinnen und Bürger veranlasst wird. Und doch birgt die Vergegenständlichung einige Herausforderungen. Mit und in diesem Herausgeberband, der an der Technischen Universität Chemnitz entstanden ist, fragen wir uns: Mit welchem Paradigma wird sie belegt? Können wir das Konstrukt philosophisch fassen? Wie können Prozessmodelle der sozialen Innovation visualisiert werden? Welche Besonderheiten treten bei der Evaluierung und Steuerbarkeit auf? Und sind Non Profit Organisationen ein Inkubator für soziale Innovationen? Somit intendieren wir im vorliegenden Band einen holistischen Blick auf das beschriebene Phänomen für Wissenschaftler, Studierende und Interessierte. / Social Innovation - It is regarded as an elixir of modern societies, but sparse named in social togetherness. Politicians and scholars see it as the key to new social practices, which is caused by citizens. However, the clarification contains some challenges. In this publication, which was developed at Technische Universität Chemnitz, we ask: Which paradigm is deposited? Can we comprehend the construct philosophically? How can process models of social innovation be visualized? Are there conditions of evaluation and controllability? Are non-profit organizations an incubator for social innovation? Thus, in the present volume we intend a holistic view of the described phenomenon for scientists, students and interested parties.

Auf der Suche nach der Basis von Innovationen rücken zunehmend Lernprozesse in den Vordergrund. Dies führt zu einer Verknüpfung von technologischen Entwicklungen mit Konzepten der Personal-, Organisations- und Kompetenzentwicklung. Dabei wird Bildung gern als Nebenprodukt, Voraussetzung oder Konsequenz technischer, ökonomischer oder sozialer Innovationen behandelt. Im Rahmen der vorliegenden Arbeit wird das Ineinandergreifen von Innovations- und Bildungsaktivitäten thematisiert und zur übergreifenden Fragestellung: Wie, wann und warum unterstützen organisationale Bildungsaktivitäten das Hervorbringen von Innovationen? Zur Beantwortung der Forschungsfragen wird einer explorativen Forschungsstrategie sowie einer qualitativen Forschungsmethodologie gefolgt. Im Rahmen einer Fallstudie wurden sieben Organisationen untersucht. Durch die Analyse der empirischen Daten konnte das soziale Agieren aufgedeckt sowie eine Tiefenstruktur erarbeitet werden. Die Erkenntnisse führen zur Konstruktion einer Innovationsdidaktik, die eingehend beschrieben wird und mit Implikationen für den Innovationsalltag verknüpft ist. / In the search for the basis of innovation, learning processes increasingly emerge in the foreground. This leads to a linkage of technological developments with concepts of personnel, organisational and competence development. Education is often treated as a co-product, prerequisite or consequence of technical, economic or social innovations. Within the present work, the linkage of innovation and education practices is addressed and the general question is: How, when and why do organisational education activities support the production of innovations? To answer the research questions, an explorative research strategy and a qualitative research methodology will be used. Within the framework of a case study, seven organisations were examined. Through the analysis of the empirical data, social action was uncovered and a depth structure was elaborated. The findings lead to the construction of an innovation didactic, which is described in detail and linked with implications for everyday innovation life.

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