"This book is an excursion into the drug development process, from the initial conception in a chemical or molecular biology lab, via tests in isolated cells and animals, to the stage of clinical trials. The human body is a complex ecosystem where little is conclusively known in terms of its response to medication, for both sick and healthy individuals. The considerable degree of uncertainty inherent in health-related research can lead to approval of controversial medicines, particularly in high-stakes scenarios and medical crises. Real-life examples are drawn on here to explain the decision making processes behind the acceptance of new drugs, disproving misconceptions around medicines by delving into the history and current practice of the drug development process. Originally written in Italian, How Medicines are Born helps patients, students, public health officials physicians, healthcare practitioners and biomedical scientists make informed decisions on the benefits and disadvantages of select medicine based on an understanding of the history of drug development. Published in Italian (2014), M D'Incalci & L Vozza, Come Nascono le Medicine; La scienza imperfetta dei farmaci. Bologna: Zanichelli"--Publisher's website.

This book is an excursion into the drug development process, from the initial conception in a chemical or molecular biology lab, via tests in isolated cells and animals, to the stage of clinical trials. The human body is a complex ecosystem where little is conclusively known in terms of its response to medication, for both sick and healthy individuals. The considerable degree of uncertainty inherent in health-related research can lead to approval of controversial medicines, particularly in high-stakes scenarios and medical crises. Real-life examples are drawn on here to explain the decision making processes behind the acceptance of new drugs, disproving misconceptions around medicines by delving into the history and current practice of the drug development process.Originally written in Italian, How Medicines are Born helps patients, students, public health officials physicians, healthcare practitioners and biomedical scientists make informed decisions on the benefits and disadvantages of select medicine based on an understanding of the history of drug development.Published in Italian (2014), M D'Incalci & L Vozza, Come Nascono le Medicine; La scienza imperfetta dei farmaci. Bologna: ZanichelliRelated Link(s)

The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.

The epic history of how antibiotics were born, saving millions of lives and creating a vast new industry known as Big Pharma. As late as the 1930s, virtually no drug intended for sickness did any good; doctors could set bones, deliver babies, and offer palliative care. That all changed in less than a generation with the discovery and development of a new category of medicine known as antibiotics. By 1955, the age-old evolutionary relationship between humans and microbes had been transformed, trivializing once-deadly infections. William Rosen captures this revolution with all its false starts, lucky surprises, and eccentric characters. He explains why, given the complex nature of bacteria—and their ability to rapidly evolve into new forms—the only way to locate and test potential antibiotic strains is by large-scale, systematic, trial-and-error experimentation. Organizing that research needs large, well-funded organizations and businesses, and so our entire scientific-industrial complex, built around the pharmaceutical company, was born. Timely, engrossing, and eye-opening, Miracle Cure is a must-read science narrative—a drama of enormous range, combining science, technology, politics, and economics to illuminate the reasons behind one of the most dramatic changes in humanity’s relationship with nature since the invention of agriculture ten thousand years ago.

Chemistry and chemical engineering have changed significantly in the last decade. They have broadened their scopeâ€"into biology, nanotechnology, materials science, computation, and advanced methods of process systems engineering and controlâ€"so much that the programs in most chemistry and chemical engineering departments now barely resemble the classical notion of chemistry. Beyond the Molecular Frontier brings together research, discovery, and invention across the entire spectrum of the chemical sciencesâ€"from fundamental, molecular-level chemistry to large-scale chemical processing technology. This reflects the way the field has evolved, the synergy at universities between research and education in chemistry and chemical engineering, and the way chemists and chemical engineers work together in industry. The astonishing developments in science and engineering during the 20th century have made it possible to dream of new goals that might previously have been considered unthinkable. This book identifies the key opportunities and challenges for the chemical sciences, from basic research to societal needs and from terrorism defense to environmental protection, and it looks at the ways in which chemists and chemical engineers can work together to contribute to an improved future.

Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.

This report presents the recommendations of the WHO Expert Committee responsible for updating the WHO Model List of Essential Medicines. The first part contains a progress report on the new procedures for updating the Model List and the development of the WHO Essential Medicines Library. It continues with a section on changes made in revising the Model List followed by a review of some sections such as hypertensive medicines and fast track procedures for deleting items. Annexes include the 13th version of the Model List and items on the list sorted according to their 5-level Anatomical Therapeutic Chemical classification codes.