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Working Mother
The magazine that helps career moms balance their personal and professional lives.
Accelerating the Development of New Drugs and Diagnostics
Advances in technologies and knowledge are creating new avenues for research and opportunities for the discovery and clinical development of innovative therapies and diagnostics. However, despite these opportunities, only a small fraction of investigational products are successfully developed into cures and therapies that can be accessed by patients. One response to the ever-widening gap between the number and promise of basic scientific discoveries and the translation of those discoveries into therapies is a renewed emphasis on collaborative approaches among federal agencies, academia, and industry, all directed at the advancement of the drug development enterprise. The newly developed Cure...
Working Mother
The magazine that helps career moms balance their personal and professional lives.
Real-World Evidence Generation and Evaluation of Therapeutics
The volume and complexity of information about individual patients is greatly increasing with use of electronic records and personal devices. Potential effects on medical product development in the context of this wealth of real-world data could be numerous and varied, ranging from the ability to determine both large-scale and patient-specific effects of treatments to the ability to assess how therapeutics affect patients' lives through measurement of lifestyle changes. In October 2016, the National Academies of Sciences, Engineering, and Medicine held a workshop to facilitate dialogue among stakeholders about the opportunities and challenges for incorporating real-world evidence into all stages in the process for the generation and evaluation of therapeutics. Participants explored unmet stakeholder needs and opportunities to generate new kinds of evidence that meet those needs. This publication summarizes the presentations and discussions from the workshop.
Building a National Framework for the Establishment of Regulatory Science for Drug Development
The Food and Drug Administration (FDA) is tasked with ensuring the safety and effectiveness of medicine. FDA's science base must be strong enough to make certain that regulatory decisions are based on the best scientific evidence. The IOM held a public workshop on February 26, 2010, to examine the state of regulatory science and to consider approaches for enhancing it.
The Antidote
In 1989, the charismatic Joshua Boger left Merck, then America's most admired business, to found a drug company that would challenge industry giants and transform health care. Journalist Barry Werth described the company's tumultuous early days during the AIDS crisis in The Billion-Dollar Molecule, a celebrated classic of science and business journalism. Now he returns to tell the story of Vertex's bold endurance and eventual success. The pharmaceutical business is America's toughest and one of its most profitable. It's riskier and more rigorous at just about every stage than any other business, from the towering biological uncertainties inherent in its mission to treat disease; to the 30-to-1 failure rate in bringing out a successful medicine; to the multibillion-dollar cost of ramping up a successful product; to operating in the world's most regulated industry, matched only by nuclear power. Werth captures the full scope of Vertex's 25-year drive to deliver breakthrough medicines.--From publisher description.
Strong on the Outside, Dying on the Inside
"Strong on the Outside, Dying on the Inside is a wonderfully written tribute to faith, courage, hope and healing." Don't be fooled by the small size of this book. In it, Lisa Brown packs a powerful message of liberation: With the help of God and qualified professionals, Black women can break free from depression. A successful businesswoman in Washington, D.C., Lisa uses her own experience and the Biblical story of Hannah to shed light on the unspoken sadness that plagues so many Black women today. With the energy, humor and compassion of a close girlfriend, she describes the signs of depression and charts a way out. Depression is an equal-opportunity illness. But Black women - especially tho...
Inclusion
With Inclusion, Steven Epstein argues that strategies to achieve diversity in medical research mask deeper problems, ones that might require a different approach and different solutions. Formal concern with this issue, Epstein shows, is a fairly recent phenomenon. Until the mid-1980s, scientists often studied groups of white, middle-aged men - and assumed that conclusions drawn from studying them would apply to the rest of the population. But struggles involving advocacy groups, experts, and Congress led to reforms that forced researchers to diversify the population from which they drew for clinical research. While the prominence of these inclusive practices has offered hope to traditionally underserved groups, Epstein argues that it has drawn attention away from the tremendous inequalities in health that are rooted not in biology but in society. This edition is in two volumes. The second volume ISBN is 9781458732194.
Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis
To effectively treat patients diagnosed with drug-resistant (DR) tuberculosis (TB) and protect the population from further transmission of this infectious disease, an uninterrupted supply of quality-assured (QA), second-line anti-TB drugs (SLDs) is necessary. Patients diagnosed with multidrug-resistant tuberculosis (MDR TB)-a disease caused by strains of Mycobacterium tuberculosis (M.tb.) resistant to two primary TB drugs (isoniazid and rifampicin)-face lengthy treatment regimens of 2 years or more with daily, directly observed treatment (DOT) with SLDs that are less potent, more toxic, and more expensive than those used to treat drug-susceptible TB. From 2000 to 2009, only 0.2-0.5 percent o...
