Klaus Rose - Böcker

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 addition, the book covers why most pediatric regulatory studies lack medical sense and many even harm young patients and the conflicts of interest behind pediatric drug studies. It includes relevant information about the maturation of the human body regarding absorption, distribution, metabolism and excretion of food and drugs as well as key differences between newborns, infants, older children and adolescents.

Explains relevant information about the maturation of the human body regarding absorption, distribution, metabolism and excretion of food and drugs, including key differences between newborns, infants, older children and adolescents Discusses historical roots of separate drug approval in officially labeled "children" and conflicts of interest in performing and publishing "pediatric" research Helps to decipher justifications for pediatric studies to help people navigate the relevance of the information

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 setting up yet another bureaucratic institution. At least the pharmaceutical or life science industry paved the way out, but is not enthusiastically praised for it. It would be too easy and superficial to blame mistakes of governments and leaders on stupidity. Idiocy exists, but we have to go deeper to understand how illusions and blind spots in today's common perception and science, inertia, arrogance, conflicts of interest, competition of individuals, and states and institutions for public recognition have contributed to a multitude of flawed assessments and direct mistakes. Healthcare professionals and anyone interested in an in-depth understanding of humankind's response to the COVID-19 challenge will not get around the key conclusions of this book.

Outlines key elements of modern civilization, public health, and drug and vaccine development on the background of the COVID-19 pandemic Discusses the historical roots of separate drug approval of vaccines and drugs in administratively classified "children" (of whom many are bodily mature long before their 16th or 18th birthday), and why the belated approval of vaccines against COVID-19 in minors is not based on science, but on blurs and conflicts of interest Outlines key elements we need to address to become better prepared for future global health challenges. In the first place, we do not need new institutions, but to overcome intellectual barriers and blind spots

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 but by a courageous man, press reports, and a changed social perception. The non-hiding of handicapped children is not the result of government orders, there are many non-resolvable dilemmas and tension between supporting, understanding, and patronizing a complex situation with many potential future avenues.

Recognizes how contradictory feelings and attitudes toward impaired persons have a complex historical background Sheds light on society and our institutions that deal with disabled people and the limitations of an isolated medical approach Covers national and international conventions of mentally impaired persons

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 the youngest ones. So far, pediatric formulations were more a focus for academic researchers. Through the changed regulatory environment, there is now a sudden high commercial demand for age-appropriate formulations. This book begins by highlighting the anatomical, physiological and developmental differences between adults and children of different ages. It goes on to review the existing technologies and attempts to draw a roadmap to better, innovative formulations, in particular for oral administration. The regulatory, clinical, ethical and pharmaceutical framework is also addressed.

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 the youngest ones. So far, pediatric formulations were more a focus for academic researchers. Through the changed regulatory environment, there is now a sudden high commercial demand for age-appropriate formulations. This book begins by highlighting the anatomical, physiological and developmental differences between adults and children of different ages. It goes on to review the existing technologies and attempts to draw a roadmap to better, innovative formulations, in particular for oral administration. The regulatory, clinical, ethical and pharmaceutical framework is also addressed.

An insider's look into the world of pediatric drug trials: when research outcomes can quite literally represent life or deathMany 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.

Since the first edition in 2014 pediatric drug development has expanded in several dimensions. There have been significant changes on the technical level, as have been in the assessment of the regulatory demands. This 2nd edition gives an overview and update on both aspects. This is not a “how to formulate“ textbook, but an attempt to equip the reader with necessary information on the technical, the regulatory, and the historical level.