The immense challenges posed by the market integration imperative and democratic transition havebrought about different reactions in the national legal systems and legal cultures of both old and new Member States. As such, Europe has effectively been reunited, but what about the convergence of national legal cultures? This is the focal point of the remaining chapters, which focus on various issues, from internal market, competition law, consumer welfare, liberalization of network industries to the EU capital market. The magnitude of EU activity in these areas offers conclusive evidence that old and new paradigms are evolving and shaping the future of the EU.
The book begins by defining the roles played by each of the key team members working with the life care planner. It provides planners with insights critical to successful interactions with medical and health-related professionals as well as the team members they are most likely to encounter as they work to build a successful and accurate life care plan. Next, the book offers up-to-date information on the disabilities most frequently encountered by the life care planner. The contributors also address issues typically left out of similar texts which have been made critical by Daubert v. Merrell Dow in the forensic setting — issues related to ethics, standards, research and credentials.Build a Client-Centered Life Care Plan
Includes the Updated Standards of Practice from the International Academy of Life Care Planners (IALCP)
Supplies Valuable Step-by-Step Charts and Checklists
Completely Revised and Expanded with Five New Chapters
When you’ve been hurt in an accident, dealing with insurance companies and lawyers can feel exhausting. But armed with the right information, you can handle a claim yourself—and save many thousands of dollars in the process.
How to Win Your Personal Injury Claim shows you how to handle almost any accident situation and guides you through the insurance claim process, step by step. Learn how to:
protect your rights after an accident
determine what your claim is worth
deal with uncooperative doctors and insurance companies
counter the special tactics insurance companies use
prepare a claim for compensation
negotiate a full and fair settlement
stay on top of your case if you hire a lawyer
This completely updated edition of How to Win Your Personal Injury Claim provides your state’s most recent laws, including small claims court limits and lawsuit filing deadlines.
Dealing with insurance companies and lawyers when filing a personal injury claim can feel like another accident is in the offing. But you can handle a claim yourself -- and save hundreds or thousands of dollars in the process.
How to Win Your Personal Injury Claim shows you how to handle almost every accident situation, and guides you through the insurance claim process, step by step. Learn how to:
protect your rights after an accident
determine what your claim is worth
handle a property-damage claim
deal with uncooperative doctors, lawyers, and insurance companies
counter the tactics insurance companies use
prepare a claim for compensation
negotiate a full and fair settlement
stay on top of your case if you hire a lawyer
This edition of How to Win Your Personal Injury Claim provides your state's most recent laws, small-claims court limits and Department of Insurance contact information. Plus, you'll find a new chart explaining your state's in-car text and cell phone laws.
In the first book to explore the new landscape of cannabis in the United States, investigative journalists Alyson Martin and Nushin Rashidian present a deeply researched, insightful story of how recent developments tie into cannabis’s complex history and thorny politics. Reporting from nearly every state with a medical cannabis law, Martin and Rashidian enliven their book with in-depth interviews with patients, growers, doctors, entrepreneurs, politicians, activists, and regulators. They whisk readers from the federal cannabis farm at the University of Mississippi to the headquarters of the ACLU to Oregon’s "World Famous Cannabis Café." They present an expert analysis of how recent milestones toward legalization will affect the war on drugs both domestically and internationally. The result is an unprecedented and lucid account of how legalization is manifesting itself in the lives of millions.
A New Leaf offers an essential guide for anyone who wants to understand the far-ranging implications of this rapidly changing drug landscape.
But by chance America’s Bitter Pill ends up being much more—because as Brill was completing this book, he had to undergo urgent open-heart surgery. Thus, this also becomes the story of how one patient who thinks he knows everything about healthcare “policy” rethinks it from a hospital gurney—and combines that insight with his brilliant reporting. The result: a surprising new vision of how we can fix American healthcare so that it stops draining the bank accounts of our families and our businesses, and the federal treasury.
Praise for America’s Bitter Pill
“A tour de force . . . a comprehensive and suitably furious guide to the political landscape of American healthcare . . . persuasive, shocking.”—The New York Times
“An energetic, picaresque, narrative explanation of much of what has happened in the last seven years of health policy . . . [Brill] has pulled off something extraordinary.”—The New York Times Book Review
“A thunderous indictment of what Brill refers to as the ‘toxicity of our profiteer-dominated healthcare system.’ ”—Los Angeles Times
“A sweeping and spirited new book [that] chronicles the surprisingly juicy tale of reform.”—The Daily Beast
“One of the most important books of our time.”—Walter Isaacson
“Superb . . . Brill has achieved the seemingly impossible—written an exciting book about the American health system.”—The New York Review of Books
From the Hardcover edition.
The rules for claiming Social Security have changed. Find out if you still qualify to “file and suspend” benefits or to choose between your own benefits and spousal benefits before these strategies disappear. Learn this and more with Social Security, Medicare & Government Pensions—completely updated for 2017.
Social Security benefits. Figure out how to get retirement, disability, dependents and survivors benefits, or Supplemental Security Income (SSI). Decide whether it’s best to claim benefits early, at full retirement age, or not until you turn 70—and how to time your claims so you and your spouse get the best benefits.
Medicare & Medicaid. Learn how to qualify for and enroll in both programs, including Medicare Part D drug coverage.
Medigap insurance & Medicare Advantage plans. Understand what new Medigap policies are available (and old ones that aren’t), compare Medigap and Medicare Advantage plans, and choose what’s best for you.
Government pensions & veterans benefits. Discover when and how to claim the benefits you have earned. Whether you’re looking for yourself or helping a parent, you’ll find valuable information here, including how to file many essential forms online.
Supplying the advice of a recognized expert in global healthcare, the book provides a detailed and empathic understanding of patient needs and expectations. It covers the full range of best and worst case scenarios that can occur when clients travel to obtain health services. Using a conversational tone, it includes coverage of international travel logistics, where to find answers to immigration concerns, confidentiality/privacy issues, and unanticipated care in transit in the event of complications or missed connections.
The book delivers a fast-moving presentation of useful information and teaches readers how to decode the language, what to look for in terms of safety and quality, how to decode hospital facilitator agent agreements, and how to anticipate clients’ needs and expectations. It also includes access to a regularly updated website with helpful worksheets and reference material so you will be prepared to handle any scenario that might present itself when your clients travel.
Too little salt in the diet can shift the body into semi-starvation mode and cause insulin resistance, and may even cause you to absorb twice as much fat for every gram you consume. Too little salt in certain populations can actually increase blood pressure, as well as resting heart rate. We need salt in order to hydrate and nourish our cells, transmit nerve signals, contract our muscles, ensure proper digestion and breathing, and maintain proper heart function. The Salt Fix will show how we wrongly demonized this essential micronutrient as well as explain what the current science really says about this misunderstood mineral and how to maximize its effect so you can enjoy ideal health and longevity.
Early chapters urge the evaluation of legal, medical, and ethical standards, especially the Standard of Care. Part II focuses on assessing and proving compensatory and punitive damages, Part III sets out guidelines for intelligence gathering, medical research, choosing expert witnesses, and preparing for trial.
Students of law, medicine, and public health, as well as lawyers and health care professionals, will find in Medical Malpractice a valuable text or reference book. "Problems" in twelve of the thirteen chapters illustrate the range of issues that can arise in malpractice suits. An appendix lists leading cases that have shaped medical malpractice law.
Maintaining the high standards of the previous edition of this bestseller, the current editors have fully revamped this reference to match the education and reference needs of today’s LNC. Adding a wealth of new information, the book has been split into two volumes: Legal Nurse Consulting Principles, designed for students, and Legal Nurse Consulting Practices, a solid professional reference that practicing LNCs will consult again and again.
Legal Nurse Consulting Practices provides the professional LNC with a wealth of new content covering processes and legal considerations in a number of areas. It explores forensics work and administrative healthcare law including insurance regulations and fraud. It discusses keys aspects of Medicare, approaches to creating a life care plan, the legal aspects of advanced practice nursing, and key concepts related to pediatrics and neonatal care. The book also describes the competencies and necessary background needed for certification and provides advice on how to advance within the profession.
An authoritative reference for practitioners:
Includes samples of effective and ineffective cross-examinations
Explores evidentiary issues
Provides guidelines for setting up an LNC practice
Examines the role of LNCs in various fields
Reviews the healthcare claims process
Discusses case evaluation for a variety of special needs patients
Contains review questions at the end of each chapter to refresh practicing LNCs
Those wishing guidance on the basics of LNC should check out the companion volume, Legal Nurse Consulting Principles. These volumes are also available as a set.
Tricky concepts are illustrated and explained with clarity and precision, as The Human Brain Book looks at how the brain sends messages to the rest of the body, how we think and feel, how we perform unconscious actions (for example, breathing), explores the nature of genius, asks why we behave the way we do, explains how we see and hear things, and how and why we dream. Physical and psychological disorders affecting the brain and nervous system are clearly illustrated and summarized in easy-to-understand terms.
Through an objective examination of marijuana and alcohol, and the laws and social practices that steer people toward the latter, the authors pose a simple yet rarely considered question: Why do we punish adults who make the rational, safer choice to use marijuana instead of alcohol? For those unfamiliar with marijuana, Marijuana Is Safer provides an introduction to the cannabis plant and its effects on the user, and debunks some of the government's most frequently cited marijuana myths.
More importantly, for the millions of Americans who want to advance the cause of marijuana policy reform--or simply want to defend their own personal, safer choice--this book provides the talking points and detailed information needed to make persuasive arguments to friends, family, coworkers, elected officials and, of course, future voters.
Science is on the cusp of a revolutionary breakthrough. We now understand more about aging—and how to prevent and reverse it—than ever before.
In recent years, our understanding of the nature of aging has grown exponentially, and dramatic life extension—even age reversal—has moved from science fiction to real possibility.
Dr. Michael Fossel has been in the forefront of aging research for decades and is the author of the definitive textbook on human aging. In The Telomerase Revolution, he takes us on a detailed but highly accessible scientific journey, providing startling insights into the nature of human aging.
Twenty years ago, there was still considerable debate of the nature of human aging, with a variety of competing theories in play. But scientific consensus is forming around the telomere theory of aging. The essence of this theory is that human aging is the result of cellular aging. Every time a cell reproduces, its telomeres (the tips of the chromosomes) shorten. With every shortening of the telomeres, the cell’s ability to repair its molecules decreases. It ages. Human aging is the result of the aging of the body’s trillions of cells.
But some of our cells don’t age. Sex cells and stem cells can reproduce indefinitely, without aging, because they create telomerase. Telomerase re-lengthens the telomeres, keeping these cells young.
The Telomerase Revolution describes how telomerase will soon be used as a powerful therapeutic tool, with the potential to dramatically extend life spans and even reverse human aging. Telomerase-based treatments are already available, and have shown early promise, but much more potent treatments will become available over the next decade.
The Telomerase Revolution is the definitive work on the latest science on human aging, covering both the theory and the clinical implications. It takes the reader to the forefront of the upcoming revolution in human medicine.
It is now evident that the "illegal biologicals" he referred to included the pathogenic agents which have led to the AIDS epidemic and other world health crisis.
In The Extremely Unfortunate Skull Valley Incident the authors trace history of the secret war against and the terrible experiments performed upon their own citizens as well as the Third World populations. But Skull Valley does more than that. In their research the father-son team discovered the links between AIDS and many other diseases now increasing dramatically worldwide. Chief among these is myalgic encephalomyelitis/fibromyalgia dismissively labelled " chronic fatigue syndrome" by the government researchers.
In addition to AIDS and ME/FM the Scotts also demonstrate the etiological links to other neurosystemic degenerative diseases such as Alzheimer's, multiple sclerosis, Parkinson's, diabetes, schizophrenia, Crohn's-colitis, etc. All are said to be "of no known cause and having no known cure". Researchers Donald and William Scott have discovered that there is a "known cause" and there may well be a cure.
The cause is a little known organism called the "mycoplasma" which has the capacity to access genetically pre-disposed cells and to destroy them by up-taking pre-formed sterols. This process is the "degeneration" which characterizes all of the diseases under study. When the cells of the endocrine system are destroyed by a sufficient concentration of mycoplasmas, the balance of the physiological balance is altered and the immune system loses its ability to defend the infected victim, and co-factors such as the human immune-deficiency virus (HIV), and those with cause pneumonia, are free to have their way, leading to full-blown AIDS.
Healthcare Information Systems, Second Edition approaches these challenges and opportunitites as pieces of a complex puzzle. It not only brings you up-to-date on the technology involved, but also explains how that technology interrelates and affects healthcare organizations. The book gives you complete coverage of all aspects of information technology as it relates to the healthcare industry.
In Healthcare Information Systems you will find:
An overview of healthcare systems
Tips on disaster planning and system security
Improving quality, reducing risks, and understanding costs
An in-depth look into the HIPAA regulations
EMR and the data warehouse
Information on managing the healthcare community
A look at the changing organization
Views on telemedicine, the Internet, and emerging technologies
Ideas on using IT to deal with increasing government regulation
In addition, the new edition has expanded coverage of HIPAA, wireless networks and communications, telemedicine, and the increasing role of the Internet in all facets of healthcare. Healthcare Information Systems presents workable solutions to the real problems you will face both today and tomorrow.
HIPAA is the federal statute that requires healthcare providers to safeguard patient identities, medical records and protected health information (“PHI”). It further requires organizations that handle PHI to regularly review the administrative, physical and technical safeguards they have in place.
Basically, HIPAA took established confidentiality healthcare practices of physicians and healthcare providers to protect patients’ information and made it law.
Risk assessments are a key requirement of complying with HIPAA. Covered entities must complete a HIPAA risk assessment to determine their risks, and protect their PHI from breaches and unauthorized access to protected information. There are many components of risk assessments, which can often seem burdensome on healthcare providers.
Let Lori-Ann Rickard and Lauren Sullivan guide you and your company as you tackle the risk assessments required by HIPAA.
We all have a rage circuit we can’t fully control once it is engaged as R. Douglas Fields, PhD, reveals in this essential book for our time. The daily headlines are filled with examples of otherwise rational people with no history of violence or mental illness suddenly snapping in a domestic dispute, an altercation with police, or road rage attack. We all wish to believe that we are in control of our actions, but the fact is, in certain circumstances we are not. The sad truth is that the right trigger in the right circumstance can unleash a fit of rage in almost anyone.
But there is a twist: Essentially the same pathway in the brain that can result in a violent outburst can also enable us to act heroically and altruistically before our conscious brain knows what we are doing. Think of the stranger who dives into a frigid winter lake to save a drowning child.
Dr. Fields is an internationally recognized neurobiologist and authority on the brain and the cellular mechanisms of memory. He has spent years trying to understand the biological basis of rage and anomalous violence, and he has concluded that our culture’s understanding of the problem is based on an erroneous assumption: that rage attacks are the product of morally or mentally defective individuals, rather than a capacity that we all possess.
Fields shows that violent behavior is the result of the clash between our evolutionary hardwiring and triggers in our contemporary world. Our personal space is more crowded than ever, we get less sleep, and we just aren't as fit as our ancestors. We need to understand how the hardwiring works and how to recognize the nine triggers. With a totally new perspective, engaging narrative, and practical advice, Why We Snap uncovers the biological roots of the rage response and how we can protect ourselves—and others.
From the Hardcover edition.
This volume provides formulas and procedures for determination of sample size required not only for testing equality, but also for testing non-inferiority/superiority, and equivalence (similarity) based on both untransformed (raw) data and log-transformed data under a parallel-group design or a crossover design with equal or unequal ratio of treatment allocations. It contains a comprehensive and unified presentation of statistical procedures for sample size calculation that are commonly employed at various phases of clinical development. Each chapter includes, whenever possible, real examples of clinical studies from therapeutic areas such as cardiovascular, central nervous system, anti-infective, oncology, and women's health to demonstrate the clinical and statistical concepts, interpretations, and their relationships and interactions.
The book highlights statistical procedures for sample size calculation and justification that are commonly employed in clinical research and development. It provides clear, illustrated explanations of how the derived formulas and/or statistical procedures can be used.
The book begins with a general coverage of the characteristics of swine and the swine industry with emphasis on the gastrointestinal tract. It then describes the various classes of nutrients and how these nutrients are metabolized by swine and the factors affecting their utilization. The next section covers the practical aspects of swine nutrition from birth through gestation and lactation in sows and to the feeding of adult boars. The nutritional aspects of the various feedstuffs commonly fed to swine are covered in the following section. The final chapters of the book are devoted to coverage of various techniques used in swine nutrition research.
Examining hypothetical cases drawn from the most prevalent and typical officer-involved deaths in recent years, Investigation and Prevention of Officer-Involved Deaths reviews the circumstances, relevant discussions, and critical issues for each case type wherein law enforcement officers have had to respond outside of their usual and trained experience and where the final outcome was the death of either the suspect, an innocent bystander, or the officer.
With a focus on crime scene investigation and the collection and preservation of the relevant forensic evidence, the book outlines appropriate crime scene procedures for each situation and lists potential categories of forensic evidence to be searched for, collected, and submitted to the forensic laboratory for analysis. The authors discuss postmortem protocols, including autopsy reports, toxicological analyses, and other appropriate investigative findings. They then examine policy and training protocols for each, look at the use and potential benefit of less-lethal weapons, and pose the critical question of "what would you do if you were the police officer."
Through the serious study of each of the categories presented in this book, police officers and other groups of law enforcement officials can more fully comprehend and appreciate the societal significance of such cases. The more aware, sensitive, and well-educated are officers of the law, the more dignified, humane, and safe are the communities they are sworn to serve.
Rapid advances in DNA sequencing technology have led to a major change in the way that prokaryotes are classified. Sequence analysis of highly conserved regions of the bacterial genome, such as the small subunit rRNA gene, now provide us with a universal method of estimating the evolutionary relationships among all organisms. Such gene-based phylogenetic classifications have led to many new discoveries about prokaryotes that were not reflected in the classification used in the first edition of the Manual. We now know that the prokaryotes fall into two broad domains: the Archaea and the Bacteria. Whereas the Archaea were once thought of as the more primitive of the prokaryotic lineages, we now realize that they are more closely related to the eukaryotes than to the Bacteria by this measure. We have come to realize that many taxa based on shared phenotypic features may be quite distinct from one another based on phylogenetic evidence. The Chromatium, a genus of anoxygenic photosynthetic bacteria are more closely related to E. coli than to some other lineages of anoxygenic photosynthetic bacteria; Mycoplasma and other cell-wall deficient species are members of the Gram-positive clade; the medically important Chlamydia are aligned with the Planctomyces; and the Clostridium, which form a phenotypically coherent group, fall into more than a dozen phylogenetically disparate groups of Gram-positive bacteria. We have also come to realize that prokaryotes represent one of the major sources of biodiversity in nature and play a major role in the functioning of all ecosystems.
In addition to such fundamental revelations, the widespread application of new methods of classifying prokaryotes has led to an explosive growth in the number of validly published species and higher taxa. Since completion of the first edition of the Manual, the number of published species has more than tripled and has been accompanied by numerous taxonomic realignments that take into consideration newly published findings.
Phylogenetic classification is now broadly accepted as the preferred method of representing taxonomic relationships among prokaryotes and eukaryotes alike. While the evolutionary history of the prokaryotes is far from complete, there is already sufficient data to provide a reasonable view of the major lines of descent of the cultivable species. Although the second edition of the Manual retains it’s unique and highly structured style of presentation of information along genus and species lines, the arrangement of content is along the phylogenetic lines of the small subunit rRNA gene, so that the reader is presented with the information in a more natural, biological perspective. The second edition of the Manual also contains more in-depth ecological information about individual taxa and many new introductory essays.
In the preface to the first edition of Bergey’s Manual of Determinative Bacteriology, published in 1923, one of the stated goals of that work was to "stimulate efforts to perfect the classification of bacteria..." The editors of the first edition regarded the Manual as "a progress report leading to a more satisfactory classification in the future" rather than a definitive classification. Bergey’s Manual Trust continues in this tradition and recognizes that, for the Manual to remain scientifically meaningful and useful to the scientific community, it is time for the new edition.
Overview of the second edition of the Manual
As before, the Manual is subdivided into multiple volumes and each genus occurs as a separate chapter with introductory text provided at higher taxonomic levels. The second edition differs from the first in that clinically relevant species are not grouped together into two volumes. Rather, these taxa appear in their proper phylogenetic place. The text is arranged to follow the lineages defined by the large-scale phylogenetic trees maintained by the Ribosomal Database Project and the ARB Project to which a formalized, hierarchical taxonomy and nomenclature have been applied. As volume 2 goes to press, the taxonomy encompasses 6466 species that are assigned to 26 phyla, 41 classes, 88 orders, 240 families and 1194 genera. Each volume contains a collection of introductory essays on the history and use of the Manual; a detailed discussion of the prokaryotic domains; overviews of the classification, identification, and naming of prokaryotes; prokaryotic ecology and phylogeny; the role of culture collections in microbiology; and intellectual property of prokaryotes. Each volume also includes taxon specific essays and a detailed road map that presents the reader with a broad view of how the entire edition will be arranged, a mapping of phylogenetic groups to the phenotypic groups used in the first edition (Volume 1), or an update of newly published taxa and combinations appearing in print since the preceding volume (Volumes 2-5). The details of each volume in print (Volume 1), in press (Volume 2) or in preparation (Volumes 3-5) follow.
Volume 1 "The Archaea and the Deeply Branching and Phototrophic Bacteria" (2001) David R. Boone and Richard W. Castenholz (Volume Editors), George M. Garrity (Editor-in-Chief) with contributions from 105 colleagues. 742 pages with 320 figures and 95 tables. The volume provides descriptions of 413 species in 165 genera that are assigned to the phyla Crenarchaeota, Euryarchaeota, Aquificae, Thermatogae, Thermodesulfobacteria, "Deinococcus-Thermus", Chrysiogenetes, Chloroflexi, Thermomicrobia, Nitrospira, Deferribacteres, Cyanobacteria, and Chlorobi. In addition, the volume contains an introductory chapter to nonoxygenic, phototropic species of Bacteria belonging to the Proteobacteria and Firmicutes, which will be repeated in more detail in subsequent volumes.
Volume 2 "The Proteobacteria." (2004) Don J. Brenner, Noel R. Krieg, James T. Staley (Volume Editors), and George M. Garrity (Editor-in-Chief) with contributions from 339 colleagues. The volume provides descriptions of more than 2000 species in 538 genera that are assigned to the phylum Proteobacteria. This volume is subdivided into three parts. Part A, The Introductory Essays (332 pgs, 76 figures, 37 tables); Part B, The Gammaproteobacteria (1203 pages, 222 figures, and 300 tables); and Part C The Alpha-, Beta-, Delta-, and Epsilonproteobacteria (1256 pages, 512 figures, and 371 tables).
Volume 3 "The Firmicutes". (2005 anticipated). Paul De Vos, Dorothy Jones, Fred A. Rainey, Karl-Heinz Schleifer, Joseph Tully, (Volume Editors) and George M. Garrity (Editor-in-Chief), with contributions from 120 colleagues. This volume will provide descriptions of more than 1346 species in 235 genera belonging to the phylum Firmicutes. Anticipated length 2100 pages.
Volume 4 "The Actinobacteria". (2006 anticipated) 1141 species in 106 genera. Estimated page length: 878 with 192 tables and 321 figures. Michael Goodfellow, Peter Kaempfer, Peter H.A. Sneath, Stanley T. Williams (Volume Editors) and George M. Garrity (Editor-in-Chief) with contributions from 60 colleagues. This volume will provide descriptions of over 1534 species in 174 genera belonging to the phylum Firmicutes. Anticipated length 2454 pages.
Volume 5 "The Planctomycetes, Chlamydiae, Spirochetes, Fibrobacters, Bacteroidetes, Fusobacteria, Acidobacteria, Verrucomicrobia, Dictyoglomi, and Gemmatomonadetes " more than 405 species assigned to 114 genera in 10 phyla. Anticipated length: 648 pages Editors and authors under discussion.
Topics covered in Long Acting Injections and Implants include the historical development of the field, drugs, diseases and clinical applications for long acting injections and implants, anatomy and physiology for these systems, specific injectable technologies (including lipophilic solutions, aqueous suspensions, microspheres, liposomes, in situ forming depots and self-assembling lipid formulations), specific implantable technologies (including osmotic implants, drug eluting stents and microfabricated systems), peptide, protein and vaccine delivery, sterilization, drug release testing and regulatory aspects of long acting injections and implants.
This volume provides essential information for experienced development professionals but was also written to be useful for scientists just beginning work in the field and for others who need an understanding of long acting injections and implants. This book will also be ideal as a graduate textbook.
The recent International Conference on Harmonisation (ICH) revisions of regulatory requirements for quality, nonclinical, and clinical pharmaceutical product registration are the focus of this timely update.
This cutting-edge resource includes the major headings in the modular structure of the Common Technical Document (CTD), which is now the agreed format for product information submission. The format, specification, and technical requirements of the e-CTD, the electronic version of CTD, are also thoroughly discussed.
The book is organized into six highly practical segments:Part I: CTD, eCTD, Module 1, and Environmental Risk Assessment Part II: CTD Summaries Part III: Quality Topics Part IV: Nonclinical Topics Part V: Clinical Topics Part VI: Other Topics (including drug-device combination products)
This text is a must-have for those in the pharmaceutical industry determining regulatory requirements for the major world markets in Europe, the US, Canada, and Japan.
A comprehensive reference, the book includes definitive information on every aspect of the anatomy, pathophysiology, and differential diagnosis of infectious diseases affecting reptiles. Beginning with a thorough review of the biology, anatomy, and histology of reptiles, the introductory chapters cover all major systems and provide the most complete single source for color images of reptile histology. It addresses the mechanism of reptile immunology and the response to pathogens, and explains how immunological response is key to differential diagnosis. Given the difficulty in isolating certain pathogens for identification, the book provides an overview of electron microscopy, complete with electron micrographs of reptile pathogens, and introduces the necessity of molecular methods for diagnosis. The text outlines serodiagnostics and the development and use of immunological reagents specifically designed for reptiles in tests such as indirect enzyme linked immunosorbent assays (ELISA). Finally, the book devotes several chapters to the viral, bacterial, fungal, and parasitic diseases known to reptiles and methods for isolating these pathogens.
With up-to-the-minute data, a never-before-seen collection of images, and a stellar panel of contributors, Infectious Diseases and Pathology of Reptiles is the definitive resource forveterinarians, biologists, and researchers involved in the study of pathogens infecting reptiles.
The book focuses on issues occurring at various stages of clinical research and development, including early-phase clinical development (such as bioavailability/bioequivalence), bench-to-bedside translational research, and late-phase clinical development. Numerous examples illustrate the impact of these issues on the evaluation of the safety and efficacy of the test treatment under investigation. The author also offers recommendations regarding possible resolutions of the problems.
Written by one of the preeminent experts in the field, this book provides a useful desk reference and state-of-the art examination of problematic issues in clinical trials for scientists in the pharmaceutical industry, medical/statistical reviewers in government regulatory agencies, and researchers and students in academia.
Includes practical examples from recent trials
Bringing together leading statisticians, scientists, and clinicians from the pharmaceutical industry, academia, and regulatory agencies, Multiple Testing Problems in Pharmaceutical Statistics explores the rapidly growing area of multiple comparison research with an emphasis on pharmaceutical applications. In each chapter, the expert contributors describe important multiplicity problems encountered in pre-clinical and clinical trial settings.
The book begins with a broad introduction from a regulatory perspective to different types of multiplicity problems that commonly arise in confirmatory controlled clinical trials, before giving an overview of the concepts, principles, and procedures of multiple testing. It then presents statistical methods for analyzing clinical dose response studies that compare several dose levels with a control as well as statistical methods for analyzing multiple endpoints in clinical trials. After covering gatekeeping procedures for testing hierarchically ordered hypotheses, the book discusses statistical approaches for the design and analysis of adaptive designs and related confirmatory hypothesis testing problems. The final chapter focuses on the design of pharmacogenomic studies based on established statistical principles. It also describes the analysis of data collected in these studies, taking into account the numerous multiplicity issues that occur.
This volume explains how to solve critical issues in multiple testing encountered in pre-clinical and clinical trial applications. It presents the necessary statistical methodology, along with examples and software code to show how to use the methods in practice.
This book provides a comprehensive guide to the methodology involved in the development of cell lines and the cell engineering approach that can be employed to enhance productivity, improve cell function, glycosylation and secretion and control apoptosis. It presents an overall picture of the current topics central to expression engineering including such topics as epigenetics and the use of technologies to overcome positional dependent inactivation, the use of promoter and enhancer sequences for expression of various transgenes, site directed engineering of defined chromosomal sites, and examination of the role of eukaryotic nucleus as the controller of expression of genes that are introduced for production of a desired product. It includes a review of selection methods for high producers and an application developed by a major biopharmaceutical industry to expedite the cell line development process. The potential of cell engineering approch to enhance cell lines through the manipulation of single genes that play important roles in key metabolic and regulatory pathways is also explored throughout.
The book has been conceived to fill the void in existing physician reference materials, and provides a comprehensive review of the theoretical knowledge and scope of pharmacotherapy in individuals who are hooked on a psychoactive substance.
While detailed scientific information is obtainable in other major articles, the book's straightforward format and style, along with its illustrations, will make for easy reading as emphasis is put on information specifically related to drugs that occur most abused in today’s society. The information provided is based on clinical practice rather than pure experimental data, which will give the physician more effective tools useful in their daily practice. Many mechanisms of action of abuse are described in detail and references are provided to direct the reader to further sources for additional information.
As a special feature, the book incorporates uncluttered tables and charts, which result in immediate clarification of the mode of action on the central nervous system and the reason for misuse, thus avoiding usual long and fatiguing text in common reference books. The book aims to give the reader a clear and concise plan on what to do when being faced with an overdose situation.
A well-organized Table of Contents rapidly leads the reader from general pharmacological issues to the specific overdose syndrome and its management. Additionally, significant emphasis is placed on the practical do's and don’ts for physicians, with special reference to the predictive signs of aberrant drug-related behavior and the identification of the drug diverter by using urine drug screening.
Divided into five sections, the book begins with emerging issues in clinical trial design and analysis, including the roles of modeling and simulation, the pros and cons of randomization procedures, the design of Phase II dose-ranging trials, thorough QT/QTc clinical trials, and assay sensitivity and the constancy assumption in noninferiority trials. The second section examines adaptive designs in drug development, discusses the consequences of group-sequential and adaptive designs, and illustrates group sequential design in R. The third section focuses on oncology clinical trials, covering competing risks, escalation with overdose control (EWOC) dose finding, and interval-censored time-to-event data.
In the fourth section, the book describes multiple test problems with applications to adaptive designs, graphical approaches to multiple testing, the estimation of simultaneous confidence intervals for multiple comparisons, and weighted parametric multiple testing methods. The final section discusses the statistical analysis of biomarkers from omics technologies, biomarker strategies applicable to clinical development, and the statistical evaluation of surrogate endpoints.
This book clarifies important issues when designing and analyzing clinical trials, including several misunderstood and unresolved challenges. It will help readers choose the right method for their biostatistical application. Each chapter is self-contained with references.
This book provides a roadmap to the broad and varied career development opportunities in bioengineering, biotechnology, and related fields. Eminent practitioners lay out career paths related to academia, industry, government and regulatory affairs, healthcare, law, marketing, entrepreneurship, and more.
Lifetimes of experience and wisdom are shared, including "war stories," strategies for success, avoidance of common pitfalls, and discussions of the authors’ personal views and motivations. Career Development in Bioengineering and Biotechnology is an indispensable guide to some of the most exciting career and professional growth opportunities in science, engineering, and beyond, and a "must read" for anyone interested in a career related to this burgeoning field.
From the Foreword by U.S. National Medal of Science Laureate and Institute Professor Robert Langer, Massachusetts Institute of Technology: "This book provides a wealth of information and should serve as an excellent resource...The editors have gone to great effort to discuss a variety of critical topics in the burgeoning areas of bioengineering and biotechnology."
From the Introduction by Dr. Bruce Alberts, President Emeritus of the U.S. National Academy of Sciences and Co-chair of the InterAcademy Council: "I am very impressed with the enormous dedication and skill that created this major, highly-original contribution – I know of nothing like it."
From the Editorial by Dr. Joachim Nagel, President, International Union for Physical and Engineering Sciences in Medicine, and past president of the International Federation for Medical and Biological Engineering: "This book provides all the answers and can be highly recommended as the ultimate guide to anyone interested in bioengineering and biotechnology. The book arrives at a crucial time, and catapults bioengineering and biotechnology to the forefront of disciplines and to a rightly held pinnacle of inspiration for engineers, scientists, and technologists."
From the Afterword by Dr. Shu Chien, President, Biomedical Engineering Society and past president of the American Physiological Society and of the American Institute of Medical and Biological Engineering: "...this is truly an outstanding book that is the first of its kind...certainly a pioneering contribution."
Praise for the Book
"Bioengineering and Biotechnology are emerging as distinct disciplines amid the biological revolution and during a period of rapid globalization. These interesting times offer us unprecedented opportunities for professional and personal growth. This book covers many important areas of opportunity, including entrepreneurship, finance, law, and education, with a global perspective. The legacy of our times will include how well we used our rapidly advancing technologies to improve the world around us. This book provides a roadmap for the contributions of Bioengineering and Biotechnology in this quest."
-James E. Moore, PhD, Texas A&M University
"This book will be essential reading for all those seeking career guidance in bioengineering and biotechnology."
-Tony Bradshaw, PhD, Director bioProcessUK - BioIndustry Association (BIA), Chairman, The Royal Academy of Engineering/BIA Life Scientists' Career Seminars
"...the topics [are] quite extensive covering definitions, core curriculum, career opportunities, including a wide range of alternative career pathways as well as social and ethical issues. The material covered is unlike any of the standard publications related to these fields of activity... [the book] can be read at different stages of one's career."
-Joseph D. Bronzino, PhD, Trinity College
"...once I started reading it, [I] could not put it down. In less than three days, I read it all, absorbing the stories and details as if I was consummed by watching a high action movie... The breath and depth of the wisdom is phenomenal, and the stories shared by the writers are moving, inspiring, and shine of intelligence in seizing one's own passion and talents and turning them into stellar professional careers."
-Nathalie Gosset, MS, MBA, Head of Marketing, Alfred Mann Institute for Biomedical Engineering, University of Southern California
"This is a functional book with immediate impact, and is very helpful to those who need and desperately want help in making a career choice."
- Jonathan Newman, Graduate Student in Biomedical Engineering, Georgia Institute of Technology, USA
"This is an exciting undertaking and very well thought through and balanced. I enjoyed very much reading the chapters I have reviewed. Congratulations to all contributors and the editors of this book."
- Gudrun Zahlmann, PhD, Director of Business Development, Siemens Medical Systems, Germany
"I am very excited about this book. As a bioengineering educator, I am always looking for information that can provide guidance for students as they prepare for their careers. The contributors in this book are so enthusiastic about their careers that many of the chapters made me want to switch careers on the spot! I believe that engineering students do not receive enough guidance on alternative career paths. This book will very much help fill the void."
- Judy Cezeaux, PhD, Professor of Biomedical Engineering, Western New England College, Massachusetts, USA
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