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.
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.
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.
is rooted in philosophical beliefs about values, concepts, and the nature of
knowledge. In order to appreciate these
philosophical beliefs, several key concepts and terms require consideration and
understanding. Complicating the novice
researcher’s understanding of these ideas is the unfortunate reality that
existing definitions can be confusing. This
situation can leave students feeling overwhelmed and confused.
purpose of this book is to provide an overview of major inquiry or research
paradigms in a simplified way. The terms
discussed in this book include, but are not limited to:
Keep in mind that the terms covered in this book
are often debated, understood, and communicated in multiple “correct” ways. Also, due to the evolving nature of knowledge
and diverse perspectives within the literature, this book serves as an
introduction to research terminology that will help you understand, follow, and
even participate in this debate. This
book will be particularly useful to nursing students
who are learning about nursing inquiry.
Nursing is a field in which inquiry skills are integral to the
development of best evidence and furthering of the profession as a whole.
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.
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.
With research gleaned from the National Institutes of Health, T.S. Wiley and Bent Formby deliver staggering findings: Americans really are sick from being tired. Diabetes, heart disease, cancer, and depression are rising in our population. We’re literally dying for a good night’s sleep.
Our lifestyle wasn’t always this way. It began with the invention of the lightbulb.
When we don’t get enough sleep in sync with seasonal light exposure, we fundamentally alter a balance of nature that has been programmed into our physiology since day one. This delicate biological rhythm rules the hormones and neurotransmitters that determine appetite, fertility, and mental and physical health. When we rely on artificial light to extend our day until 11 p.m., midnight, and beyond, we fool our bodies into living in a perpetual state of summer. Anticipating the scarce food supply and forced inactivity of winter, our bodies begin storing fat and slowing metabolism to sustain us through the months of hibernation and hunger that never arrive. Our own survival instinct, honed over millennia, is now killing us.
Wiley and Formby also reveal:
-That studies from our own government research prove the role of sleeplessness in diabetes, heart disease, cancer, infertility, mental illness, and premature aging
-Why the carbohydrate-rich diets recommended by many health professionals are not only ridiculously ineffective but deadly
-Why the lifesaving information that can turn things around is one of the best-kept secrets of our day.
Lights Out is one wake-up call none of us can afford to miss.
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.
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.
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
Since its discovery in 1953 by Watson and Crick, the DNA double helix has been thought of as the language of God. From that point on, throughout the ensuing decades, research has decoded much of that language, giving scientists a more respectable insight into the paradox of life itself. Now, furthering that insight, Dr. Luksas has determined a means of using that language to address cancer and perhaps other diseases.
Providing a wealth of information on DNA and how it functions in the body, as well as other processes important to the replication of cancerous bodies such as cell respiration and metastasis, Dr. Luksas explains his findings with the common reader in mind.
reference to key US FDA Guides and regulations via your electronic reader. An
excellent way to access the reference documents on your e-reader. No need to
carry paper books and you can search for key terms.
In this issue you will find:
E6 Good Clinical Practice
Guidance for Industry Part 11, Electronic
Records; Electronic Signatures — Scope and Application
CFR 21-- General Part 11, Electronic Records;
21 CFR PART 50 Protection Of Human Subjects
21 CFR Part 54 Financial Disclosure By Clinical
21 CFR PART 56 Institutional Review Boards
Title 21 PART 312 Investigational New Drug
ICH E2A Clinical Safety Data Management:
Definitions and Standards for Expedited Reporting
ICH E8 General Considerations For Clinical
- concerning the human body, it is the 3rd constituent element of all connective tissue,
- concerning our planet, it is the 2nd constituent element of the earth's crust.
In other words, silicium is an essential element of our total make-up and also of our immediate environment. It is a full participant in cellular regeneration:
- to compensate for the loss of or to re-establish one’s initial vital capital with the knowledge that, at approximately age 35-40, this capital is almost nil,
- to carry information (this specific property is essentially due to its peripheral electrons which are numerous and tend to be naturally emitted). In fact, this property is very widely used in new technologies such as computers, magnetic cards…
- dosed at 0,3 ‰, it favours packaging in quantities of 100 ml, avoiding efficiency loss caused by contact with air (as is the case with 1 litre bottles at 0,2 ‰),
- accepts a definitely higher energy level when maintained in a field of natural energy (efficiency multiplied by 100) essentially due to spring water (without the slightest trace of chemical treatments) and also due to the alchemy generated by quartz crystals.
THIS SILICIUM IS CALLED "ORTHO-MOLECULAR"
Organic Silicium "ORTHOSIL" is highly energetic. It accepts a higher quantity of information than its counterparts and restores it for optimal efficiency. This dew, called the “full moon of Easter” (gathered according to the laws of alchemy), known as the Norbert Duffaut Remedy or NDR, named after the father of organic silicium, along with the pure spring waters of the Pyrenees, result in a final product unlike any other.
BIO-CONCEPTS – F 09300 – LESPARROU
The picture is more blurred when the molecular diagnostic tools are to be used by physicians, scientists and technicians working in diagnostic laboratories in hospitals, industry and academic institutions. Since many of them are not trained in basics of these methods, they come across several gray areas in understanding of these tools. The accurate application of molecular diagnostic tools demands in depth understanding of the methodology for precise detection of the abnormal condition of living body.
To meet the requirements of a good book on molecular diagnostics of students, physicians, scientists working in agricultural, veterinary, medical and pharmaceutical sciences, it needs to expose the reader lucidly to:
Give basic science behind commonly used tools in diagnostics
Expose the readers to detailed applications of these tools and
Make them aware the availability of such diagnostic tools
The book will attract additional audience of pathologists, medical microbiologists, pharmaceutical sciences, agricultural scientists and veterinary doctors if the following topics are incorporated at appropriate places in Unit II or separately as a part of Unit-III in the book.
Molecular diagnosis of diseases in agricultural crops
Molecular diagnosis of veterinary diseases.
Molecular epidemiology, which helps to differentiate various epidemic strains and sources of disease outbreaks. Even in different units of the same hospital, the infections could be by different strains of the same species and the information becomes valuable for infection control strategies.
Drug resistance is a growing problem for bacterial, fungal and parasitic microbes and the molecular biology tools can help to detect the drug resistance genes without the cultivation and in vitro sensitivity testing. Molecular diagnostics offers faster help in the selection of the proper antibiotic for the treatment of tuberculosis, which is a major problem of the in the developing world. The conventional culture and drug sensitivity testing of tuberculosis bacilli is laborious and time consuming, whereas molecular diagnosis offers rapid drug resistant gene detection even from direct clinical samples. The same approach for HIV, malaria and many more diseases needs to be considered.
Molecular diagnostics in the detection of diseases during foetal life is an upcoming area in the foetal medicine in case of genetic abnormalities and infectious like TORCH complex etc.
The book will be equally useful to students, scientists and professionals working in the field of molecular diagnostics.
Now, that evidence has been discovered.
A thrilling scientific detective story, The Balance Within tells how researchers finally uncovered the elusive mind-body connection and what it means for our health. In this beautifully written book, Dr. Esther Sternberg, whose discoveries were pivotal in helping to solve this mystery, provides first hand accounts of the breakthrough experiments that revealed the physical mechanisms - the nerves, cells, and hormones - used by the brain and immune system to communicate with each other. She describes just how stress can make us more susceptible to all types of illnesses, and how the immune system can alter our moods. Finally, she explains how our understanding of these connections in scientific terms is helping to answer such crucial questions as "Does stress make you sick?" "Is a positive outlook the key to better health?" and "How do our personal relationships, work, and other aspects of our lives affect our health?"
A fascinating, elegantly written portrait of this rapidly emerging field with enormous potential for finding new ways to treat disease and cope with stress, The Balance Within is essential reading for anyone interested in making their body and mind whole again.
Emerging, re-emerging, and antibiotic-resistant infectious diseases continue to increase at an alarming rate throughout the world. Written for a wide range of health professionals, particularly nurses, this revised edition provides a comprehensive and up-to-date overview of these diseases: their epidemiology, clinical manifestations, prevention, and treatment.
With contributions by a multidisciplinary team of nurses, physicians, and infectious disease specialists, the book includes material on the most recent and important new emerging infectious diseases:
Avian influenza and SARSIssues of demographics and microbial resistanceSpecial topics, including bioterrorismBehavioral and cultural factorsInfectious etiologies of chronic diseasesTravel and recreational exposure
Each chapter is amply illustrated with clinical case examples to demonstrate the pitfalls in differential diagnosis and elucidate proper management and treatment. Valuable appendices provide critical reference information for each of the bacterial, viral, fungal, and parasitic diseases.
The book highlights core research skills, taking the reader through the key debates in qualitative methodology. It sets out a logical, easy-to-follow path supported by practical examples ensuring you will find it engaging and relevant.
Updates for the new edition include:
- a new chapter on effectively combining methods
- new material on the practical aspects of securing access to participants, using online data and on selecting an approach for analysis
- improved material on reading and appraising literature with detailed exploration of systematic reviews and synthesis
- expanded chapters on analysing data, with practical suggestions for moving from descriptive to analytical approaches
- an effective mix of classic and contemporary case studies from across health research
- expanded summaries, key points and reflective questions designed to help students apply theory to their own research.
Clear, thorough and articulate, this is an authoritative introduction to qualitative research for all health professionals and students.
Visit the accompanying companion website for additional resources.
Judith Green is a Professor in Sociology of Health at the London School of Hygiene and Tropical Medicine.
Nicki Thorogood is a Senior Lecturer in Sociology at the London School of Hygiene and Tropical Medicine.
Historically, drug repurposing has been largely an unintentional, serendipitous process that took place when a drug was found to have an offtarget effect or a previously unrecognized on-target effect that could be used for identifying a new indication. Perhaps the most recognizable example of such a successful repositioning effort is sildenafil. Originally developed as an anti-hypertensive, sildenafil, marketed as Viagra and under other trade names, has been repurposed for the treatment of erectile dysfunction and pulmonary arterial hypertension. Viagra generated more than $2 billion worldwide in 2012 and has recently been studied for the treatment of heart failure.
Given the widespread interest in drug repurposing, the Roundtable on Translating Genomic-Based Research for Health of the Institute of Medicine hosted a workshop on June 24, 2013, in Washington, DC, to assess the current landscape of drug repurposing activities in industry, academia, and government. Stakeholders, including government officials, pharmaceutical company representatives, academic researchers, regulators, funders, and patients, were invited to present their perspectives and to participate in workshop discussions. Drug Repurposing and Repositioning is the summary of that workshop. This report examines enabling tools and technology for drug repurposing; evaluates the business models and economic incentives for pursuing a repurposing approach; and discusses how genomic and genetic research could be positioned to better enable a drug repurposing paradigm.
Each contributor describes the most frequently used and most widely accepted version of the model, and each chapter includes: (1) a well-referenced introduction that covers the theory behind and the utility of the model; (2) a detailed and step-by-step methodology; and (3) an approach to the interpretation of the data presented. Many chapters also provide examples of actual experiments that use the method.
This text eliminates the guesswork from the process of designing the methodology for many of the animal behavioral models that are used to study brain disorders, drug abuse, toxicology, and cognitive drug development. It will also significantly reduce the time spent assessing literature and developing models for studying animal subjects. Overall, Methods of Behavioral Analysis in Neuroscience is an invaluable reference source for the professional who seeks to comprehend the effects of disease on human cognition.
"A trenchant exposé . . . meticulously researched and packed with documentary evidence" (Publishers Weekly), Sonia Shah’s riveting journalistic account shines a much-needed spotlight on a disturbing new global trend. Drawing on years of original research and reporting in Africa and Asia, Shah examines how the multinational pharmaceutical industry, in its quest to develop lucrative drugs, has begun exporting its clinical research trials to the developing world, where ethical oversight is minimal and desperate patients abound. As the New England Journal of Medicine notes, “it is critical that those engaged in drug development, clinical research and its oversight, research ethics, and policy know about these stories,” which tell of an impossible choice being faced by many of the world’s poorest patients—be experimented upon or die for lack of medicine.
reference to key US FDA Guides and regulations via your electronic reader. An
excellent way to access the reference documents on your e-reader. No need to
carry paper books and you can search for key terms.
In this issue you will find:
ICH Q8 Pharmaceutical Development
ICH Q9 Quality Risk Management
ICH Q10 Pharmaceutical Quality System
Martha Stephens’s report on these deaths led to the halting of the tests, but local papers did not print her charges, and for many years people in Cincinnati had no way of knowing that lethal experiments had taken place there. In 1994 other military tests were brought to light, and a yellowed copy of Stephens’s original report was delivered to a television newsroom. In Ohio, major publicity ensued—at long last—and reached around the world. Stephens uncovered the names of the victims, and a legal action was filed against thirteen researchers and their institutions. A federal judge compared the deeds of the doctors to the medical crimes of the Nazis during World War II and refused to dismiss the researchers from the suit. After many bitter disputes in court, they agreed to settle the case with the families of those they had afflicted. In 1999 a memorial plaque was raised in a yard of the hospital.
Who were these doctors and why had they done as they did? Who were the people whose lives they took? Who was the reporter who could not forget the story, the young attorney who first developed the case, the judge who issued the historic ruling against the doctors? This is Stephens’s moving account of all that transpired in these lives and her own during this epic battle between medicine and human rights.