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-, mid- and long-term impact, addresses key operational challenges in paediatric research, and develops a tentative vision where paediatric drug development needs to go. Helping to understand the role of the different stakeholders, the spectrum of readers to profit from this book ranges from paediatricians, general medical personnel and pharmacologists to those involved in regulatory affairs and clinical trials, pharmaceutical company management, patient advocacy groups, ethical committees, politicians and interested lay persons.
Klaus Rose Boeken






Focusing on societal attitudes and historical context, the book explores the ongoing challenges faced by intellectually impaired individuals. It examines national and international conventions, the dynamics of sheltered workshops, and the balance between self-responsibility and limitations. The narrative highlights significant events, such as the Tuskegee study, that shifted public perception, and addresses the complexities surrounding the visibility of disabled children. Ultimately, it captures the evolving conceptual frameworks and the dilemmas in supporting and understanding this community.
The COVID-19 Pandemic
A Global High-Tech Challenge at the Interface of Science, Politics, and Illusions
- 248bladzijden
- 9 uur lezen
Exploring the multifaceted impact of the COVID-19 pandemic, this book delves into the intersection of science, politics, and societal perceptions. It examines the technological advancements and challenges faced during the crisis, highlighting how misinformation and political decisions influenced public response and health outcomes. By analyzing various global strategies and their effectiveness, the work offers insights into the complexities of managing a pandemic in a high-tech world, emphasizing the lessons learned for future health emergencies.
An insider's look into the world of pediatric drug trials: when research outcomes can quite literally represent life or death Many parents of children with serious health problems may wonder why new medicines are initially not approved for minors and, if their condition is rare, why at the same time there is such pressure to enter any young person under 18 into drug trials. So-called 'paediatric' pharmaceutical studies have become an international multi-billion business, with many careers in academia, regulatory authorities and the pharmaceutical industry based on this work, yet much of this activity is founded on a series of flawed concepts that have led to an immeasurable waste of resources and serious, ongoing medical abuse. In this revelatory book, the former head of paediatric drug research at two major pharmaceutical companies provides a guide for parents and non-specialists interested in advancing the health of children--both individuals facing serious disease and groups of children enrolled in testing programs. Rose explains the key differences between clinically-directed and administratively-directed research, what will potentially benefit or harm children, and how laws need to change around the world so that true advances can be made.
Guide to paediatric drug development and clinical research
- 222bladzijden
- 8 uur lezen
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 understanding of how the child’s body develops as well as recent legislation in the USA and in Europe, this comprises dosing, ethics, age-appropriate pharmaceutical forms and clinical trials, to name just a few aspects. A wide spectrum of readers will profit from this book, including paediatricians, pharmacists, general practitioners and health care professionals involved in child care and paediatric research, clinical trial personnel, patient advocacy groups, ethics committees, politicians, parents and interested lay persons.
Richard und Anna geraten während ihres Aufenthalts auf La Gomera in eine gefährliche Situation, als sie von dem Rache suchenden Makler Alonso bedroht werden. Nach der Entdeckung eines ermordeten Handlangers und der geheimnisvollen Umstände um den Tod der attraktiven Gunda, die Verbindungen zur Aussteigerszene hat, wird das Paar schnell zum Verdächtigen. Richard entscheidet sich, die Geschehnisse im Luxusresort Palmenzauber zu untersuchen, wo er auf ein Netz aus Intrigen und kriminellen Machenschaften stößt, das von Alonso und einem korrupten Polizisten gesponnen wird.
Der Roman bietet einen fesselnden Einblick in das Leben von Abgeordneten, Journalisten und Wirtschaftsführern am Ende des 20. Jahrhunderts. Durch die Kapitel "Afrikanische Nächte", "Chinesische Drachen" und "Deutschstunde in der Karibik" wird eine facettenreiche Welt voller Widersprüche und Hoffnungen erkundet, die an die epischen Themen von Tolstois "Krieg und Frieden" anknüpft. Die Erzählung beleuchtet die komplexen Beziehungen und Herausforderungen der Protagonisten in einer sich wandelnden globalen Landschaft.
Kalinichta
du wunderschönes Land der Griechen
Eine große Liebe entfaltet sich in einem Reiseabenteuer nach Griechenland im Jahr 1980. Ein selbstgebauter Campingbus und die Aufgabe einer Altbauwohnung in München wegen einer Schwangerschaft führen zu einem Arrangement des zerstrittenen Paares, das in Griechenland in eine tragische Wendung mündet.
EINE WELTREISE ALS HOCHZEITSGESCHENK
SIEBEN MONATE FLITTERWOCHEN IN FERNEN LÄNDERN UND DAS IM RENTENALTER
Nach einem überstandenen Herzinfarkt unternimmt der Autor mit seiner Frau eine siebenmonatige Weltreise, die sie nach Bali, Australien, Neuseeland, Thailand, Laos, Vietnam, Kambodscha und schließlich Indien führt. Damit beweist der leidenschaftliche Globetrotter, dass er noch lange nicht zum alten Eisen gehört.