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The COVID-19 Pandemic
The COVID-19 Pandemic: A Global High-Tech Challenge at the Interface of Science, Politics, and Illusions discusses COVID-19 as the first pandemic in the Internet era and our current reality of continuous reports, news, and updates. Since its beginning, we were daily bombarded with news of what was happening around the world. There was no global political leadership. The United States was politically partially paralyzed. Russia and China hoped to gain diplomatic profile worldwide, but their vaccines are of limited efficacy, and trust in their clinical data is rightly low. The European Union did not order enough vaccines in time, but sued a large manufacturer for delivery delays. Now it is set...
Intellectually Impaired People
Intellectually Impaired People: The Ongoing Battle addresses challenges against the background of history, changing societal environments, and current intellectual approaches and attitudes toward persons with disabilities. The book discusses national and international conventions, societal attitudes, sheltered workshops, the right of intellectually impaired persons for self-responsibility and its limitations, and the place of mentally impaired persons in the public image. Additionally, the book attempts to capture the forces that drive the changes of our conceptual frameworks. The US Tuskegee study which withheld antibiotics from black men with syphilis was not ended by scientific criticism ...
Considering the Patient in Pediatric Drug Development
Considering the Patient in Pediatric Drug Development: How Good Intentions Turned into Harm addresses a fundamental challenge in drug development and healthcare for young patients. In clinical trials and clinical practice, the term "children" is used ambiguously to confer physiological characteristics to a chronological age limit, which in reality does not exist. This book outlines why the United States (US) and European Union's (EU) regulatory authorities, pediatric academia, and the pharmaceutical industry demand, support and perform pediatric drug studies, along with the key flaws of this demand that blurs the different administrative and physiological meanings of the term "child." In add...
Abuse of Minors in Clinical Studies
With the emergence of effective drugs and observed drug toxicities in babies, two mantras emerged: that children are therapeutic orphans, and that children are not small adults. US and EU laws demand pediatric studies as a condition for the approval of new drugs in adults. This is called “Pediatric Drug Development” (PDD). Although apparently reasonable, there are catches. Children are vulnerable at birth, but they grow and become bodily mature with puberty, well before coming of age. Minors are not another species. The 18th birthday, an administrative/ legal limit, does not correspond to a physiological change. Drugs treat the body, not the legal status. PDD results in pointless studies in bodily mature adolescents, and in exaggerated studies in younger minors. An originally well-intentioned concept results in thousands of questionable studies worldwide. This book draws attention to conflicts of interest and ethical dilemmas of PDD and questions its applicability for adolescents and minors that are no longer babies.
Pediatric Formulations
Until the 1990s, it was generally accepted that medicines were first developed for adults and their use in children was investigated later, if at all. One of the main tasks of hospital pharmacies was the manufacturing of child-appropriate formulations in a more or less makeshift way. The first change came in 1997 with U.S. legislation that rewarded manufacturers to do voluntary pediatric research. Ten years later, the European Union passed legislation that required manufacturers to discuss all pediatric aspects, including formulations, with the regulatory authorities as a condition of starting the registration procedure. In consequence, manufacturers must now cover all age groups, including ...
DU BIEST BRINGST MICH UM
Das Leben ohne seine Frau stürzt Georg in eine Lebenskrise, bis Karla seinen Weg kreuzt und ihn mit ihrer Wunderdroge Zuneigung von seinem Kummer befreit, prompt wähnt er sich im siebten Himmel. Diese Karla hievt ihn auf einen Gipfel der Glücksseligkeit. Doch trotz wunderbarem Sex und leidenschaftlicher Hingabe ziehen bald Gewitterwolken am Liebeshimmel auf, denn seine Traumfrau misshandelt die Spielregeln der Verbundenheit, aber Georg schließt vor den Turbulenzen die Augen. Er nimmt Karlas Rücksichtslosigkeit hin, anstatt sich zu wehren. Die Lage spitzt sich zu, als er Karlas Kinderwunsch ignoriert, schon hängt das Damoklesschwert der Trennung über der instabilen Verbindung. Wo bleibt Georgs Mitgefühl? Wo sein Stolz? Beides hat Karla untergraben, und das mit dem Ergebnis der Ausnahmesituation. Verdient das ungleiche Paar eine Chance? Wird es in ein ruhigeres Fahrwasser geraten?
Aussenwirtschaft
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Guide to Paediatric Clinical Research
As off-label use of medicines in children is no longer acceptable today, paediatric drug development is currently in transition from an almost exclusive academic specialty towards an integrated part of the global process that drives the development of new pharmaceuticals. US and EU governments have made it mandatory for the pharmaceutical industry to investigate medicines in children, thus exposing a multitude of different institutions to paediatric research. Written by exponents of the academia as well as the pharmaceutical industry, regulators and patient advocacy groups, this book explains the background of the US and EU paediatric legislations, gives an analysis of their probable short-,...
Guide to Paediatric Drug Development and Clinical Research
Children in the developed world have never enjoyed better medical care: mortality has decreased and many fatal diseases of the past can today be prevented or even cured. However, the current practice of pharmacotherapy in children does not reflect existing scientific knowledge and has come under scrutiny by paediatricians, pharmacists and regulatory authorities. In order to advance the development of medicines tailored to paediatric needs, US and EU legislators have taken action, and the WHO has initiated a global paediatric campaign. This book gives an overview over the worldwide activities that increasingly include children in the development of new medicines. Triggered by both a better un...
ZU LIEB FÜR DIE LIEBE
Das Liebesdrama beruht auf einer wahren Begebenheit. Es gehört zur Biographie des Autors. Nur das Ende der Liebesgeschichte ist fiktiv, könnte aber noch eintreten.
