This no-nonsense guide shows you how an understanding of anatomy and biomechanics, coupled with the latest strengthening exercises and rehab protocols, can keep you running injury-free for a long time to come. Each time your foot hits the ground while running, an impact force averaging three times your weight travels through your body at more than 200 miles per hour, causing your bones to vibrate and tendons to stretch. When you consider that the average runner strikes the ground more than 10,000 times per hour, this translates into a remarkable amount of force that needs to be absorbed, and explains why nearly 50% of recreational runners are injured each year. The purpose of this book is to show you that impact forces are not necessarily harmful. By modifying your running form and doing specific exercises to improve tendon resiliency, not only can you effectively absorb these forces, but you can also store and return a significant percentage of them in the form of elastic recoil. Besides reducing your risk of injury, efficiently storing and returning energy can allow you to run faster with less effort. With more than 200 illustrations and 300 references, this book reviews how to: Perform an at-home gait analysis to make specific changes in your running form that can reduce impact forces and improve performance. Decrease your risk of injury by identifying problems with strength, flexibility, and/or neuromotor coordination using specific functional tests. Incorporate new exercises to enhance the storage and return of energy in your tendons. Select the running shoe that is right for you. Treat 25 of the most common running-related injuries with the most up-to-date, scientifically justified treatment protocols available.
The driving force behind this book is the need to convince the populace that the danger is real and paramount: the system has decayed to the point that it would no longer be recognizable to the Framers if they were alive. If you think you are immune from attack because you follow the law, think again. You must take an active role—even simply by spreading the word—to stem the tide. This publication is not intended to be a protective guide like Stack the Legal Odds in Your Favor. It is intended to be another reliable smaller news source. It is a recounting or an exposé of true events related to the author’s and others’ legal experiences—all supported by irrefutable facts and evidence. This work should be viewed as a lengthy news article or a reporter’s marathon dialogue at the scene of an unfolding catastrophic event. People who have committed wrongdoing and crimes will be named in this book. Unlike protection associated with any form of immunity—qualified, judicial, absolute, or otherwise—nobody will evade culpability. Government lawyers, such as Kristin Tavia Mihelic, will be named. Her misconduct will be revealed. Her crimes will be exposed. Judge Louise DeCarl Adler will similarly be thrust into the spotlight. Her misconduct and crimes will also not escape exposure. The list of miscreants is lengthy and is constantly growing, but everyone within my purview who is responsible for their iniquitous or criminal acts will be held accountable in this true report. Most people who have not (yet) experienced our illustrious injustice system may think the events described herein would be part of the script for a Hollywood fantasy movie—or more appropriately, a Hollywood horror flick. This is not so. Everything put forth will be supported by rock-solid evidence. The intent of this eye-opener is to prove to readers that any outrageous system-related stories they may have heard from friends, family members, or colleagues are likely true. It is also intended to be the proverbial whack on the side of the head that some individuals need to make them understand that being struck with the syndicate is not an “other person’s disease.” Ordinary people in Amerika must wake up to the fact that chances are high they will someday encounter the toxic waste dump also known as the world’s largest crime syndicate. The information in this book is a clarion call; however, time is running out. Read it, but fasten your seatbelts first. It’s going to be one heck of a bumpy ride.....
This no-nonsense guide shows you how an understanding of anatomy and biomechanics, coupled with the latest strengthening exercises and rehab protocols, can keep you running injury-free for a long time to come. Each time your foot hits the ground while running, an impact force averaging three times your weight travels through your body at more than 200 miles per hour, causing your bones to vibrate and tendons to stretch. When you consider that the average runner strikes the ground more than 10,000 times per hour, this translates into a remarkable amount of force that needs to be absorbed, and explains why nearly 50% of recreational runners are injured each year. The purpose of this book is to show you that impact forces are not necessarily harmful. By modifying your running form and doing specific exercises to improve tendon resiliency, not only can you effectively absorb these forces, but you can also store and return a significant percentage of them in the form of elastic recoil. Besides reducing your risk of injury, efficiently storing and returning energy can allow you to run faster with less effort. With more than 200 illustrations and 300 references, this book reviews how to: Perform an at-home gait analysis to make specific changes in your running form that can reduce impact forces and improve performance. Decrease your risk of injury by identifying problems with strength, flexibility, and/or neuromotor coordination using specific functional tests. Incorporate new exercises to enhance the storage and return of energy in your tendons. Select the running shoe that is right for you. Treat 25 of the most common running-related injuries with the most up-to-date, scientifically justified treatment protocols available.
History and the Social Web was first published in 1955. Minnesota Archive Editions uses digital technology to make long-unavailable books once again accessible, and are published unaltered from the original University of Minnesota Press editions. In this volume of twelve essays a distinguished historian demonstrates that the roots and branches of history form a continuous social web, that the events and societies of pasts eras and modern times form a complex and interlocking pattern when seen as a whole, and that a knowledge of history has a profound application to the problems and pleasures of the present. The volume includes the well-known essay, "A City That Art Built," which has long been out of print. The first group of essays is devoted to aspects of medieval and renaissance history, and those in the second section point up the continuity of the thread of world history. The essays on law, education, and medicine which form a part of the first section will be of particular interest to members of these professions
This is a life story of a Hungarian refugee born in Slovakia in 1938 amidst the beginning of World War II. Parents were a Jewish father and a Catholic mother. Following the end of WWII, the Krieser family moved to Hungary, and Tom escaped directly following the Hungarian Revolution against Soviet Russia, which was crushed by the Red Army. Arriving in Canada with nothing but a diary, a birth certificate, and a determination to succeed, Tom was lucky enough to meet up with the Sheehan family, who helped to determine much of Toms future. The Sheehans helped Tom attend and successfully graduate in engineering from St. FX University. It was in the town of Saint John, New Brunswick (Canada), that Tom met his wife-to-be Jane OLeary. They married in 1960 and had two children (Paul and Mark in 1961 and 1963, respectively) growing up in Montreal, Canada. Toms career commenced as a young engineer, but over the years, he eventually was elevated to become the president and CEO of one of Canadas best recognized pulp and paper machinery manufacturing enterprises with up to five hundred employees. Surrounded by a great team of professionals and many great customers in a dynamic, competitive, yet surprisingly friendly business environment, the company became known for its research and development activities, machinery innovation, and commitment to deliver value to its customers the world over. Despite the enormous stress of the job he held, Tom found time to dedicate much attention to his kids (having become a spokesperson for the English section of the Quebec PTA [Parent Teacher Association]) and his church, including leadership positions in the Worldwide Marriage Encounter movement. Tom even became a deacon in the Catholic Church in the diocese of Montreal. Toms marriage to Jane came to an end in 1989, and in 1993, Tom married his wife of today, Linda Thibodeau. Lindas daughter became like Toms own, and that is a story in its own. Tom and Linda live in beautiful Naples, Florida, today. The book is full of twists and turns with experiences gained through a very enriching life and extensive business, family, and traveling adventures. Tom still works today because he loves what he does and thrives to be the best in all things he undertakes. This book is a product of his love of family, business, friends, and life.
William Lyon Mackenzie King / René Lévesque / Samuel de Champlain / John Grierson / Lucille Teasdale / Maurice Duplessis / David Thompson / Mazo de la Roche / Susanna Moodie / Gabrielle Roy
William Lyon Mackenzie King / René Lévesque / Samuel de Champlain / John Grierson / Lucille Teasdale / Maurice Duplessis / David Thompson / Mazo de la Roche / Susanna Moodie / Gabrielle Roy
Presenting ten titles in the Quest Biography series that profiles prominent figures in Canada’s history. The important Canadian lives detailed here are: influential politicians Prime Minister William Lyon Mackenzie King and Premiers René Lévesque and Maurice Duplessis; intrepid explorers Samuel de Champlain and David Thompson; National Film Board founder John Grierson; medical humanitarian Lucille Teasdale; and renowned writers Mazo de la Roche, Susanna Moodie, and Gabrielle Roy. Includes Willam Lyon Mackenzie King René Lévesque Maurice Duplessis Samuel de Champlain David Thompson John Grierson Lucille Teasdale Susanna Moodie Gabrielle Roy Mazo de la Roche
This book is an exploration of nonviolent strategies and tactics that have been used to prevent and end civil wars, invasions, and occupations. The problem of war is examined in light of efforts to transform destructive conflict into constructive conflict. Research into alternatives has produced a corpus of knowledge that enables civil society increasingly to expect success when it engages decision-makers in peaceful conflict resolution. The book asks the reader to consider the questions of social conflict using a cost-benefit analysis--which can reveal the advisability of strategic nonviolence. Research into the causes and correlates of war is robust, and when that research is applied to comparisons of conflict management methods, numerous conclusions about potential strategies for ending war emerge.
Aim for a target-based grading system and create stronger learning opportunities! Do you wish there was more clarity when it comes to measuring student progress and learning? What if there was a way to utilize grading and assessment to focus on learning rather than performance, and the process rather than the product? As grading, assessment, and reporting continue to be relevant topics of discussion, this book helps you create a functional plan to elevate and advance standards-based grading practices. Teachers and administrators will learn how to assess, grade, and report against specific learning targets rather than standards as a whole to make skill acquisition the highest priority. Grounded in application to provide focus and clarity, this book features: Real case studies of schools that have incorporated target-based assessment, feedback, grading, and reporting Practical examples to guide implementation Questions, checklists, illustrations, and audits of practice to showcase the work in action An accessible format and layout that support both immediate implementation and long-term goals Despite being a topic that generates emotion and resistance to change, target-based assessment builds the foundation for a learner-centered system that provides clear expectations and feedback for teachers, students, and parents. "Grading for Impact is a simple and straightforward guide to re-thinking grading based on mastery of specific skills and concepts rather than broadly-written standards. Real-world examples of teachers struggling with--and answering--the old questions are included: "How do we grade fairly and accurately?" and "How do we use grades as an instructional strategy?"" Joseph Staub, High School Teacher Downtown Magnets High School, CA "Most stakeholders agree that report cards aren’t enough to show what our students are learning in school, but changing the traditional grading system is a task that requires careful planning and challenging discussions. Grading for Impact shows educators how to start and plan the discussions that will result in genuine learning experiences for students." Ernie Rambo, Virtual Learning Community Coordinator Nevada National Board Professional Learning Institute
The Wars of Religion embroiled France in decades of faction, violence, and peacemaking in the late sixteenth century. When historians interpret these events they inevitably depend on sources of information gathered by contemporaries, none more valuable than the diaries and collection of Pierre de L'Estoile (1546-1611), who lived through the civil wars in Paris and shaped how they have been remembered ever since. Taking him out of the footnotes, and demonstrating his significance in the culture of the late Renaissance, this is the first life of L'Estoile in any language. It examines how he negotiated and commemorated the conflicts that divided France as he assembled an extraordinary collection of the relics of the troubles, a collection that he called "the storehouse of my curiosities." The story of his life and times is the history of the civil wars in the making. Focusing on a crucial individual for understanding Reformation Europe, this study challenges historians' assumptions about the widespread impact of confessional conflict in the sixteenth century. L'Estoile's prudent, non-confessional responses to the events he lived through and recorded were common among his milieu of Gallican Catholics. His life-writing and engagement with contemporary news, books, and pictures reveals how individuals used different genres and media to destabilize rather than fix confessional identities. Bringing together the great variety of topics in society and culture that attracted L'Estoile's curiosity, this volume rethinks his world in the Wars of Religion.
This monograph presents the proceedings of the 2002 Spring Symposium sponsored by the Lake Champlain Research Consortium, hosted by the Missisquoi Bay Watershed Corporation. The book examines this common body of water shared by Canada and the US, and summarizes knowledge of the dynamics of this system with a primary focus on land use, water management, and bridging the gap between researchers and the public.
Spring in Maryland means one thing: lacrosse. As much a part of the state as crab cakes and the Chesapeake Bay, lacrosse is king at every level, from youth rec and club to high school, college and the pros. Since the state first fielded teams in the 1870s, Marylanders have played with a unique combination of finesse, speed and passion. The "Maryland style" of play built a long line of national powerhouses at all levels. With extensive research and dozens of photographs, journalist Tom Flynn traces the long history of the sport in Maryland from its Native American roots to its first arrival in the state and on to the modern highlights. Fans will rediscover their many past champions and gain a glimpse of teams that promise to elevate the sport's status as the pride of the Old Line State.
This advanced textbook covering the fundamentals and industry applications of process intensification (PI) discusses both the theoretical and conceptual basis of the discipline. Since interdisciplinarity is a key feature of PI, the material contained in the book reaches far beyond the classical area of chemical engineering. Developments in other relevant disciplines, such as chemistry, catalysis, energy technology, applied physics, electronics and materials science, are extensively described and discussed, while maintaining a chemical engineering perspective. Divided into three major parts, the first introduces the PI principles in detail and illustrates them using practical examples. The second part is entirely devoted to fundamental approaches of PI in four domains: spatial, thermodynamic, functional and temporal. The third and final part explores the methodology for applying fundamental PI approaches in practice. As well as detailing technologies, the book focuses on safety, energy and environmental issues, giving guidance on how to incorporate PI in plant design and operation -- safely, efficiently and effectively.
Scientific and Technical Report No. 24 Performance-Based Contracts (PBC) for Improving Utilities Efficiency: Experiences and Perspectives is a compendium of articles written by members of the PBC taskforce. It focuses on new approaches without delegated management to private operator i.e. service contracts, consulting contracts, Alliance approach, public-public partnership. It also mentions new design and generation of more traditional PPPs, (MC, lease, concession), where a larger proportion of performance-based design is being applied. List of Contents: Performance Based Contracts – Setting the scene; PBC and Results Based Financing: the inverse approach; PBC and Energy Efficiency; Internal Performance Contracts: A Case of the National Water and Sewerage Corporation in Uganda; Performance-Based Service Contracts in Navi Mumbai; Financial Comparison of PBCs and Conventional Approach; Tegucigalpa PBC Case Study; Performance Based Contracts – Key Design Issues; NRW Reduction Optimization Framework; How to improve water services performance? Performance Based Contracts (PBC) and Regulatory issues; Peer-to-Peer Partnerships Operational for sustainable water services; Performance Based Contracts in Malawi: Teamwork Works; Performance based affermage contracts; Performance based Contracts, The Aroona Integrated Alliance Experience; Experience from Eastern Europe; NRW Performance Contract – Kingdom of Bahrain; The way forward and perspectives/trends
Offering a broad and vivid survey of the culture of collecting from the French Revolution to the Belle Époque, The Purchase of the Past explores how material things became a central means of accessing and imagining the past in nineteenth-century France. By subverting the monarchical establishment, the French Revolution not only heralded the dawn of the museum age, it also threw an unprecedented quantity of artworks into commercial circulation, allowing private individuals to pose as custodians and saviours of the endangered cultural inheritance. Through their common itineraries, erudition and sociability, an early generation of scavengers established their own form of 'private patrimony', independent from state control. Over a century of Parisian history, Tom Stammers explores collectors' investments – not just financial but also emotional and imaginative – in historical artefacts, as well as their uncomfortable relationship with public institutions. In so doing, he argues that private collections were a critical site for salvaging and interpreting the past in a post-revolutionary society, accelerating but also complicating the development of a shared national heritage.
Tricia Jenkins and Tom Secker deliver a highly original exploration of how the government-entertainment complex has influenced the world’s most popular movie genre—superhero films. Superheroes, Movies, and the State sets a new standard for exploring the government-Hollywood relationship as it persuasively documents the critical role different government agencies have played in shaping characters, stories, and even the ideas behind the hottest entertainment products. Jenkins and Secker cover a wide range of US government and quasi-governmental agencies who act to influence the content of superhero movies, including the Department of Defense, the National Academy of Sciences’ Science and Entertainment Exchange and, to a lesser extent, the FBI and the CIA. Superheroes, Movies, and the State deploys a thematic framework to analyze how five of the key themes of our time—militarism, political radicalism and subversion, the exploration of space, the role of science and technology, and representation and identity—manifest in the superhero genre, and the role of the government in molding narratives around these topics. The book includes interviews with both producers and influencer insiders and covers a wide range of superhero products, from 1970s TV shows up to the most recent movie and TV releases, including the first major analysis of the hit Amazon show The Boys. In addition, it is the first deep exploration of NASA’s Hollywood office and the first detailed account of the role of the Science and Entertainment Exchange, which has worked on thousands of products since its creation in 2008 but is little known outside of the industry. Superheroes, Movies, and the State offers an innovative blend of research methods and interpretive frameworks, combining both production histories and deep readings of superhero texts to clearly reveal how the government-entertainment complex works in the world of blockbuster cinema to shape public perceptions of the United States, war, science, and much, much more.
Terrifying tales of the ultimate evil among us! One of the best serial killer books for fans of true crime. The Killer Book of Serial Killers is the complete resource for any true crime fan or student of the lurid, fascinating world of serial killers. Inside you'll find a concise compilation of the world's thirty-five most notorious murderers, including an in-depth look at their crimes and the lives that turned them into monsters. This is the perfect gift for any true crime buff or psychology enthusiast. Sprinkled throughout the book are Q&A, quizzes, quotes, photos, and odd facts about serial killers and their true stories to test your knowledge and make you shudder in horrified delight, along with recommended reading to dig even deeper into their sordid lives. Learn more about notorious serial killers like: Ted Bundy Jack the Ripper Jeffrey Dahmer Gary Ridgway, the Green River Killer John Wayne Gacy Paul Bernardo and Karla Homolka Dennis Rader, the Bind, Torture, Kill (BTK) Killer Béla Kiss David Berkowitz, the Son of Sam With many more shocking tales and tidbits about serial killers that will keep you up at night!
Spencer Bower: Reliance-Based Estoppel, previously titled Estoppel by Representation, is the highly regarded and long established textbook on the doctrines of reliance-based estoppel, by which a party is prevented from changing his position if he has induced another to rely on it such that the other will suffer by that change. Since the fourth edition in 2003 the House of Lords has decided two proprietary estoppel cases, Cobbe v Yeoman's Row Property Management Ltd and Thorner v Major, whose combined effect is identified as helping to define a criterion for a reliance-based estoppel founded on a representation, namely that the party estopped actually intends the estoppel raiser to act in reliance on the representation, or is reasonably understood to intend him so to act. Other developments in the doctrine of proprietary estoppel have required a complete revision of the related chapter, Chapter 12, in this edition. Thorner v Major confirms too the submission in the fourth edition that unequivocality is a requirement for any reliance-based estoppel founded on a representation. Other views expressed in the fourth edition are also noted to have been upheld, such as the recognition that an estoppel may be founded on a representation of law (Briggs v Gleeds), that a party may preclude itself from denying a proposition by contract as well as another's reliance (Peekay Intermark Ltd v Australia and New Zealand Banking Group Ltd and Springwell Navigation Corp v JP Morgan Chase Bank) and that an estoppel by deed binds by agreement or declaration under seal rather than by reason of reliance (Prime Sight Ltd v Lavarello). With the adjustment reflected in the change of title, and distinguishing the foundation of estoppels that bind by deed and by contract, the editors adopt Spencer Bower's unificatory project by the identification of the reliance-based estoppels as aspects of a single principle preventing a change of position that would be unfair by reason of responsibility for prejudicial reliance. From this follow the views: that reliance-based estoppels have common requirements of responsibility, causation and prejudice; that estoppel by representation of fact is, like the other reliance-based estoppels, a rule of law; that the result of estoppel by representation of fact may, accordingly, be mitigated on equitable grounds to avoid injustice; that the result of an estoppel by convention depends on whether its subject matter is factual, promissory or proprietary; that a reliance-based estoppel (other than a proprietary estoppel, which uniquely generates a cause of action) may be deployed to complete a cause of action where, absent the estoppel, a cause of action would not lie, unless it would unacceptably subvert a rule of law (in particular the doctrine of consideration); that an estoppel as to a right in or over property generates a discretionary remedy; and that the prohibition on the deployment of a promissory estoppel as a sword should be understood as an application of the defence of illegality, viz that an estoppel may not unacceptably subvert a statute or rule of law.
***Please note: This ebook edition does not contain the photos found in the print edition.*** In 1991, flight attendant Nancy Ludwig checked in to an airport hotel near Detroit. The next morning she was found gagged, raped, and tortured-her throat slit with such rage that she was nearly decapitated. Her husband Arthur never gave up hope that the future would bring enough evidence to close the case. But it was the past that held the clue. In 1985, fifty-five-year old Margarette Eby, a music professor, met the same grisly death at her cottage in Flint, Michigan. The case went cold-until six years later when the victim's son Mark came upon the story of Nancy Ludwig's slaying. With nothing to go on but intuition, he called authorities, certain that the same fiend committed both crimes. A cunning sting operation yielded irrefutable DNA evidence, and authorities were led to the home of respected navy veteran Jeffrey Gorton living quietly with his wife and two children. But his cold-blooded secrets were only beginning to come to light, leaving fears that there were more victims yet to be found in a killing spree that had finally come to an end. Blood Justice shows veteran reporter and author Tom Henderson at the top of his game.
This textbook offers for the first time a comprehensive analysis of the classic doctrines and main areas of international law from a European perspective, meeting the needs of the many European law schools teaching public international law in English. Special attention is devoted to the practice of the European Union, the Council of Europe and European States – both civil law and common law countries – with regard to international law. In particular the book analyses the interplay between international law, EU law and national law in the case law of the Court of Justice of the EU, the European Court of Human Rights and national jurisdictions in Europe. It provides the reader with insights into how the international legal practice of the EU and its Member States impacts the development of international law, both in terms of doctrines such as treaty-making and customary law, the exercise of (extraterritorial) jurisdiction, state responsibility and the settlement of disputes, as well as particular sub-fields of international law, such as human rights law and international economic law. In addition the book covers other important areas such as the use of force and collective security, the law of armed conflict, and global and regional international organisations. It provides European perspectives on all these issues and will be of great value to students, scholars and practitioners.
The rhetoric of the 2012 presidential campaign exposed the deeply rooted sources of political polarization in American. One side celebrated individualism and divided the public into "makers and takers;" the other preached "better together" as the path forward. Both focused their efforts on the "base" not the middle. In Dangerous Convictions, former Democratic Congressman Tom Allen argues that what's really wrong with Congress is the widening, hardening conflict in worldviews that leaves the two parties unable to understand how the other thinks about what people should do on their own and what we should do together. Members of Congress don't just disagree, they think the other side makes no sense. Why are conservatives preoccupied with cutting taxes, uninterested in expanding health care coverage and in denial about climate change? What will it take for Congress to recover a capacity for pragmatic compromise on these issues? Allen writes that we should treat self-reliance (the quintessential American virtue) and community (our characteristic instinct to cooperate) as essential balancing components of American culture and politics, instead of setting them at war with each other. Combining his personal insights from 12 years In Congress with recent studies of how human beings form their political and religious views, Allen explains why we must escape the grip of our competing worldviews to enable Congress to work productively on our 21st century challenges.
Exploring the rich range of meanings that Shakespeare finds in the natural world, this book fuses ecocritical approaches to Renaissance literature with recent thinking about the significance of religion in Shakespeare's plays. MacFaul offers a clear introduction to some of the key problems in Renaissance natural philosophy and their relationship to Reformation theology, with individual chapters focusing on the role of animals in Shakespeare's universe, the representation of rural life, and the way in which humans' consumption of natural materials transforms their destinies. These discussions enable powerful new readings of Shakespeare's plays, including A Midsummer Night's Dream, As You Like It, King Lear, Macbeth, The Tempest, The Winter's Tale, and the history plays. Proposing that Shakespeare's representation of the relationship between man and nature anticipated that of the Romantics, this volume will interest scholars of Shakespeare studies, Renaissance drama and literature, and ecocritical studies of Shakespeare.
This "real-world" approach allows students to come away with a realistically informed view of the basis for much of our understanding of nutritional biochemistry.
Human Molecular Genetics is an established and class-proven textbook for upper-level undergraduates and graduate students which provides an authoritative and integrated approach to the molecular aspects of human genetics. While maintaining the hallmark features of previous editions, the Fourth Edition has been completely updated. It includes new Key Concepts at the beginning of each chapter and annotated further reading at the conclusion of each chapter, to help readers navigate the wealth of information in this subject. The text has been restructured so genomic technologies are integrated throughout, and next generation sequencing is included. Genetic testing, screening, approaches to therapy, personalized medicine, and disease models have been brought together in one section. Coverage of cell biology including stem cells and cell therapy, studying gene function and structure, comparative genomics, model organisms, noncoding RNAs and their functions, and epigenetics have all been expanded.
Finn gives us real gems (Darrell Squires, Library Resources Board, Newfoundland) -- sketches from the social fabric and the subtle influence of the American presence in Newfoundland, Canada, in the 1940s and 1950s. Like a ship in the mist there emerges from these ardent, tragicomic lives, a recognition of ourselves. -- * drama * relationships * desire and delusion * --
FDA's Drug Review Process and the Package Label provides guidance to pharmaceutical companies for writing FDA-submissions, such as the NDA, BLA, Clinical Study Reports, and Investigator's Brochures. The book provides guidance to medical writers for drafting FDA-submissions in a way more likely to persuade FDA reviewers to grant approval of the drug. In detail, the book reproduces data on efficacy and safety from one hundred different FDA-submissions (NDAs, BLAs). The book reproduces comments and complaints from FDA reviewers regarding data that are fragmentary, ambiguous, or that detract from the drug's approvability, and the book reveals how sponsors overcame FDA's concerns and how sponsors succeeded in persuading FDA to grant approval of the drug. The book uses the most reliable and comprehensive source of information available for writing FDA-submissions, namely text and data from NDAs and BLAs, as published on FDA's website. The source material for writing this book included about 80,000 pages from FDA's Medical Reviews, FDA's Clinical Pharmacology Reviews, and FDA's Pharmacology Reviews, from one hundred different NDAs or BLAs for one hundred different drugs. Each chapter focuses on a different section of the package label, e.g., the Dosage and Administration section or the Drug Interactions section, and demonstrates how the sponsor's data supported that section of the package label. Reveals strategies for winning FDA approval and for drafting the package label Examples are from one hundred FDA-submissions (NDAs, BLAs) for one hundred different drugs, e.g., for oncology, metabolic diseases, autoimmune diseases, and neurological diseases This book uses the most reliable and comprehensive source of information available for writing FDA-submissions, namely, the data from NDAs and BLAs as published on FDA's website at the time FDA grants approval to the drug
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