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A NEW YORK TIMES BESTSELLER

From an award-winning journalist, an explosive narrative investigation of the generic drug boom that reveals fraud and life-threatening dangers on a global scale—The Jungle for pharmaceuticals

Many have hailed the widespread use of generic drugs as one of the most important public-health developments of the twenty-first century. Today, almost 90 percent of our pharmaceutical market is comprised of generics, the majority of which are manufactured overseas. We have been reassured by our doctors, our pharmacists and our regulators that generic drugs are identical to their brand-name counterparts, just less expensive. But is this really true?

Katherine Eban’s Bottle of Lies exposes the deceit behind generic-drug manufacturing—and the attendant risks for global health. Drawing on exclusive accounts from whistleblowers and regulators, as well as thousands of pages of confidential FDA documents, Eban reveals an industry where fraud is rampant, companies routinely falsify data, and executives circumvent almost every principle of safe manufacturing to minimize cost and maximize profit, confident in their ability to fool inspectors. Meanwhile, patients unwittingly consume medicine with unpredictable and dangerous effects.

The story of generic drugs is truly global. It connects middle America to China, India, sub-Saharan Africa and Brazil, and represents the ultimate litmus test of globalization: what are the risks of moving drug manufacturing offshore, and are they worth the savings? 

A decade-long investigation with international sweep, high-stakes brinkmanship and big money at its core, Bottle of Lies reveals how the world’s greatest public-health innovation has become one of its most astonishing swindles.

 

Publisher's Note: Products purchased from Third Party sellers are not guaranteed by the publisher for quality, authenticity, or access to any online entitlements included with the product.


The most up-to-date, comprehensive, and authoritative pharmacology text in health medicine—enhanced by a new full-color illustrations

A Doody’s Core Title for 2019!

Organized to reflect the syllabi in many pharmacology courses and in integrated curricula, Basic & Clinical Pharmacology, Fourteenth Edition covers the important concepts students need to know about the science of pharmacology and its application to clinical practice. Selection of the subject matter and order of its presentation are based on the authors’ many years’ experience in teaching this material to thousands of medical, pharmacy, dental, podiatry, nursing, and other health science students.

To be as clinically relevant as possible, the book includes sections that specifically address the clinical choice and use of drugs in patients and the monitoring of their effects, and case studies that introduce clinical problems in many chapters. Presented in full color and enhanced by more than three hundred illustrations (many new to this edition), Basic & Clinical Pharmacology features numerous summary tables and diagrams that encapsulate important information.

• Student-acclaimed summary tables conclude each chapter
• Everything students need to know about the science of pharmacology and its application to clinical practice
• Strong emphasis on drug groups and prototypes
• NEW! 100 new drug tables
• Includes 330 full-color illustrations, case studies, and chapter-ending summary tables
• Organized to reflect the syllabi of pharmacology courses
• Descriptions of important new drugs

The NAPLEX Practice Question Workbook provides over 1,000 comprehensive practice questions to prepare for the demanding North American Pharmacist Licensure Examination (NAPLEX). Master exam topics with intensive practice in the areas you'll find on the test. All questions are test-level difficulty and focused solely on helping you pass. Whether you're challenging the exam for the first time or trying again after an unsuccessful attempt, you will learn the critical skills needed to master the exam.

This innovative workbook includes:
• Full-length 250 question practice exam, including multiple-response, constructed-response, and ordered-response questions
• Over 100 pharmaceutical calculation questions including ratios and conversions, alligation, total parenteral nutrition, and measurements for accurate drug doses
• Over 100 sterile & non-sterile compounding questions
• Detailed solutions to all practice questions to help you pinpoint your strengths and weaknesses and identify areas in need of further study

Included are practice exams for the following topics:
• Cardiovascular Disorders
• Infectious Diseases
• Immunologic
• Hematologic & Oncologic Disorders
• Neurologic & Psychiatric Disorders
• Endocrine Disorders
• Gastrointestinal Disorders
• Respiratory Disorders
• Renal & Urologic Disorders
• Bone & Joint Disorders
• Ophthalmic, Otic & Dermatologic Disorders
• Women's Health
• Nutrition Support & Critical Care
• Over-the-Counter Medications & Dietary Supplements
"Even though depression has periodically made me feel that my life was not worth living, has created havoc in my family, and sometimes made the work of teaching and writing seem impossible," writes David Karp, "by some standards, I have been fortunate." Indeed, depression can be devastating, leading to family breakups, loss of employment, even suicide. And it is a national problem, with some ten to fifteen million Americans suffering from it, and the number is growing. In Speaking of Sadness, Karp captures the human face of this widespread affliction, as he illuminates his experience and that of others in a candid, searching work. Combining a scholar's care and thoroughness with searing personal insight, Karp brings the private experience of depression into sharp relief, drawing on a remarkable series of intimate interviews with fifty depressed men and women. By turns poignant, disturbing, mordantly funny, and wise, Karp's interviews cause us to marvel at the courage of depressed people in dealing with extraordinary and debilitating pain. We hear what depression feels like, what it means to receive an "official" clinical diagnosis, and what depressed persons think of the battalion of mental health experts--doctors, nurses, social workers, sociologists, psychologists, and therapists--employed to help them. We learn the personal significance that patients attach to beginning a prescribed daily drug regimen, and their ongoing struggle to make sense of biochemical explanations and metaphors of depression as a disease. Ranging in age from their early twenties to their mid-sixties, the people Karp profiles reflect on their working lives and career aspirations, and confide strategies for overcoming paralyzing episodes of hopelessness. They reveal how depression affects their intimate relationships, and, in a separate chapter, spouses, children, parents, and friends provide their own often-overlooked point of view. Throughout, Karp probes the myriad ways society contributes to widespread alienation and emotional exhaustion. Speaking of Sadness is an important book that pierces through the terrifying isolation of depression to uncover the connections linking the depressed as they undertake their personal journeys through this very private hell. It will bring new understanding to professionals seeking to see the world as their clients do, and provide vivid insights and renewed empathy to anyone who cares for someone living with the cruel unpredictability of depression.
Comprehensive yet easy to read, Pharmacology: Principles and Applications, 3rd Edition introduces you to basic pharmacology, showing how to apply principles to the kinds of clinical situations you will encounter on the job. You'll learn how different drugs work in the body, how to calculate drug dosages, drug administration routes and procedures, the medications related to disorders in each body system, and much more. Written by expert authors Eugenia M. Fulcher, Robert M. Fulcher, and Cathy Dubeansky Soto, Pharmacology ensures that you master all of the pharmacology competencies required by CAAHEP and ABHES. In the book and on a companion Evolve website, a variety of exercises helps you strengthen your skills in math, dosage calculation, and critical thinking.Practical coverage of basic pharmacology provides a thorough understanding of the medications most commonly used in ambulatory and inpatient settings.A real-life Scenario starts each chapter with thought-provoking questions to consider as you progress through the material.Procedures boxes provide step-by-step guidance for drug calculation and administration, accompanied by numerous illustrations and icons that identify OSHA-mandated protocols.Common Signs & Symptoms of Diseases and Common Side Effects of Medications lists in each body system chapter help you distinguish between disease progression and medication reactions.Body systems icons highlight the ways that specific drugs affect a particular body system.Chapter objectives and key words at the beginning of each chapter help you focus your study efforts.Check Your Understanding math review sections enable you to assess your knowledge of application and calculation concepts.Critical Thinking exercises challenge you to apply what you've learned to a variety of realistic situations.Important Facts and Clinical Tips boxes in each chapter highlight the key concepts for practice.Patient Education for Compliance boxes help you communicate more effectively with patients about possible side effects or adverse reactions. Summary tables are more concise and easier to follow.New calculations exercises and quizzes are included on the companion Evolve website.Expanded math and drug calculation sections in the workbook supplement the textbook with additional exercises for practice with math and dosage calculations. Available separately.
Pharmacology can be difficult. But with the right text, understanding drugs and how they work doesn’t have to be! Using easy-to-follow language and engaging learning tools — like Memory Joggers, Clinical Pitfalls, Do Not Confuse, and Drug Alerts — the second edition of Understanding Pharmacology: Essentials for Medication Safety helps readers really understand how drugs work. In addition to the popular critical thinking activities from the first edition, the second edition also includes more chapter review questions, updated content, and a new organization that centers on the different body systems. For students who have a limited background in the sciences and want complete preparation for licensure exams and clinical practice, there is no better choice than Understanding Pharmacology, 2nd Edition!Entire unit reviewing math, weights and measures, and dosage calculation minimizes readers’ anxiety and promotes medication safety.Clever, easy-to-recognize margin icons help visual learners remember essential side effects of drugs.Simplified heading structure replaces intimidating terminology (i.e. pharmacokinetics) with simplified language (How These Drugs Work) to increase understanding of concepts.Drug Alert!, Do-Not-Confuse, and Clinical Pitfall boxes highlight important tips for safe medication administration.Memory Jogger boxes help readers remember important drug information.Get Ready for Practice sections at the end of each chapter include key points, chapter review questions, and critical thinking activities to reinforce learning.10th grade reading level uses straightforward, everyday language to really enhance readers’ understanding of pharmacology concepts.Incorporation of adult learning theory features both a simple to complex organization of material along with answers to why readers need to learn something.NEW! Body system organization helps readers better understand drugs that are specific to particular body systems.NEW! More chapter review questions have been added to the text. All review questions are now organized into one of two categories: Test Yourself on the Basics and Test Yourself on Advanced Concepts.
“Groundbreaking . . . the shocking account of the origins of today's opioid epidemic, the creators of this plague, and the way to help stop it.”—Sam Quinones, author of Dreamland: The True Tale of America’s Opiate Epidemic

“Prescient . . . a landmark work of investigative journalism.”—David A. Kessler, former commissioner of the Food and Drug Administration and author of The End of Overeating

Between 1999 and 2017, an estimated 250,000 Americans died from overdoses involving prescription painkillers, a plague ignited by Purdue Pharma’s aggressive marketing of OxyContin. Families, working class and wealthy, have been torn apart, businesses destroyed, and public officials pushed to the brink.

In Pain Killer, Pulitzer Prize–winning New York Times reporter Barry Meier exposes the roots of the most pressing health epidemic of the twenty-first century. Powerful narcotic painkillers, or opioids, were once used as drugs of last resort for pain sufferers. Purdue turned OxyContin into a billion-dollar blockbuster by launching an unprecedented marketing campaign claiming that the drug’s long-acting formulation made it safer to use than traditional painkillers for many types of pain. That illusion was quickly shattered as drug abusers learned that crushing an Oxy could release its narcotic payload all at once. Even in its prescribed form, Oxy proved fiercely addictive. As OxyContin’s use and abuse grew, Purdue concealed what it knew from regulators, doctors, and patients.

Here are the people who profited from the crisis and those who paid the price, those who plotted in boardrooms and those who tried to sound alarm bells. A country doctor in rural Virginia, Art Van Zee, took on Purdue and warned officials about OxyContin abuse. An ebullient high school cheerleader, Lindsey Myers, was reduced to stealing from her parents to feed her escalating Oxy habit. A hard-charging DEA official, Laura Nagel, tried to hold Purdue executives to account. The drugmaker’s owners, Raymond and Mortimer Sackler, whose names adorn museums worldwide, made enormous fortunes from the commercial success of OxyContin.

In this updated edition of Pain Killer, Barry Meier breaks new ground in his decades-long investigation into the opioid epidemic. He takes readers inside Purdue to show how long the company withheld information about the abuse of OxyContin and gives a shocking account of the Justice Department’s failure to alter the trajectory of the opioid epidemic and protect thousands of lives. Equal parts crime thriller, medical detective story, and business exposé, Pain Killer is a hard-hitting look at how a supposed wonder drug became the gateway drug to a national tragedy.
The most comprehensive text available on the use of evidence-based medication therapies for optimal patient outcomes – updated with the latest breakthroughs and guidelines

A Doody's Core Title for 2019!

Pharmacotherapy: A Pathophysiologic Approach is written to help you advance the quality of patient care through evidence-based medication therapy derived from sound pharmacotherapeutic principles. The scope of this trusted classic goes beyond drug indications and dosages to include the initial selection, proper administration, and monitoring of drugs. You will find everything you need to provide safe, effective drug therapy across the full range of therapeutic categories.

Presented in full-color, the Tenth Edition is enriched by more than 300 expert contributors, and every chapter has been updated to reflect the latest in evidence-based information and recommendations. This sweeping updates include tables, charts, algorithms, and practice guidelines. This edition is also enhanced by a timely all-new chapter on Travel Health.

Here’s why this is the perfect learning tool for students, patient-focused pharmacists, and other health care providers:

• All chapters have been updated to provide the most current, reliable, and relevant information possible
• Key Concepts at the beginning of each chapter
• Clinical Presentation Tables summarize disease signs and symptoms
• Clinical Controversies Boxes examine the complicated issues faced by students and clinicians in providing drug therapy
• Color coded diagnostic flow diagram, treatment algorithms, dosing recommendations, and monitoring approaches clearly distinguish treatment pathways
• Most disease-oriented chapters include updated evidence-based treatment guidelines that often include ratings of the level of evidence to support the key therapeutic approaches

Edition after trusted edition, Pharmacotherapy: A Pathophysiologic Approach has been unmatched in its ability to clearly and impartially impart core pathophysiological and therapeutic elements that students and practitioners must be familiar with.

Prescribing for the first time is a nerve-wracking experience. Of all the tasks performed by new doctors, it is probably the one with greatest direct impact on the wellbeing of patients. Safe and effective practice rests on a good understanding of both clinical pharmacology and practical prescribing. Acquiring this is not easy, particularly when faced with reams of information about hundreds of unfamiliar drugs, often presented in a way that appears detached from clinical reality.

This book is your starting point. It is a direct response to requests from students for a compendium of the 100 most important drugs in the NHS. Key information about the clinical pharmacology and practical prescribing of each drug is presented side-by-side, allowing you to direct your attention as appropriate for your stage of training. Drugs can be accessed alphabetically when you need quick information on the wards and by organ system or clinical indication when you are at your desk.

Research led by Professor Emma Baker has identified the ‘top 100 drugs’ by their importance and prescribing frequency. She has shown that the list changes little over time, making it a stable resource upon which to base learning.

The top 100 drugs and the five most important intravenous fluids are presented using a clear, consistent layout across double-page spreads.

Drugs are arranged alphabetically and also listed by organ system and clinical indication, providing multiple pathways into the information.

Clinical pharmacology is discussed under the headings: common indications; mechanisms of action; important adverse effects; warnings; and important interactions.

Practical prescribing is discussed under the headings: prescription; administration; communication; monitoring; and cost.

A clinical tip is presented for every drug.

Single-best-answer questions are provided for self-assessment and to show how information from several drugs may be integrated.
Be ready to prescribe and administer drugs safely and effectively—and grasp all the vitals of pharmacology—with the fully updated Pharmacotherapeutics for Advanced Practice, 4th edition. Written by pharmacology nursing experts, this easy-to-read text offers proven frameworks for treating more than 50 common diseases and disorders. Learn how to identify disorders, review possible therapies, then prescribe and monitor drug treatment, accurately. Based on current evidence and real-life patient scenarios, this is the perfect pharmacology learning guide and on-the-spot clinical resource. Absorb the key principles and practical methods for accurate prescribing and monitoring, with . . . NEW chapter on Parkinson’s disease, osteoarthritis, and rheumatoid arthritis NEW and updated therapies, and updated and additional case studies, with sample questions NEW content on the impacts of the Affordable Care Act Updated chapters on complementary and alternative medicine (CAM) and pharmacogenomics Updated evidence-based algorithms and drug tables – Listing uses, mechanisms, adverse effects, drug interactions, contraindications, and monitoring parameters, organized by drug class; quick access to generic and trade names and dosages Quick-scan format organizes information by body system Chapter features include: Brief overview – Pathophysiology of each disorder, and relevant classes of drugs Monitoring Patient Response section – What to monitor, and when Patient Education section – Includes information on CAM for each disorder Drug Overview tables – Usual dose, contraindications and side effects, and special considerations Algorithms – Visual cues on how to approach treatment Updated Recommended Order of Treatment tables – First-, second- and third-line drug therapies for each disorder Answers to Case Study Questions for each disorder – Strengthens critical thinking skills Selecting the Most Appropriate Agent section – The thought process for choosing an initial drug therapy Principles of Therapeutics unit – Avoiding medication errors; pharmacokinetics and pharmacodynamics; impact of drug interactions and adverse events; principles of pharmacotherapy for pediatrics, pregnancy/lactation, and geriatrics Disorders units – Pharmacotherapy for disorders in various body systems Pharmacotherapy in Health Promotion unit – Smoking cessation, immunizations, weight management Women’s Health unit – Including contraception, menopause, and osteoporosis Integrative Approach to Patient Care unit – Issues to consider when presented with more than one diagnosis Standard pharmacotherapeutics text for nurse practitioners, students, and physician assistants Ancillaries – Case Study answers, multiple choice questions and answers for every chapter, PowerPoints, Acronyms List
America had a radically different relationship with drugs a century ago. Drug prohibitions were few, and while alcohol was considered a menace, the public regularly consumed substances that are widely demonized today. Heroin was marketed by Bayer Pharmaceuticals, and marijuana was available as a tincture of cannabis sold by Parke Davis and Company.

Exploring how this rather benign relationship with psychoactive drugs was transformed into one of confusion and chaos, The Cult of Pharmacology tells the dramatic story of how, as one legal drug after another fell from grace, new pharmaceutical substances took their place. Whether Valium or OxyContin at the pharmacy, cocaine or meth purchased on the street, or alcohol and tobacco from the corner store, drugs and drug use proliferated in twentieth-century America despite an escalating war on “drugs.”

Richard DeGrandpre, a past fellow of the National Institute on Drug Abuse and author of the best-selling book Ritalin Nation, delivers a remarkably original interpretation of drugs by examining the seductive but ill-fated belief that they are chemically predestined to be either good or evil. He argues that the determination to treat the medically sanctioned use of drugs such as Miltown or Seconal separately from the illicit use of substances like heroin or ecstasy has blinded America to how drugs are transformed by the manner in which a culture deals with them.

Bringing forth a wealth of scientific research showing the powerful influence of social and psychological factors on how the brain is affected by drugs, DeGrandpre demonstrates that psychoactive substances are not angels or demons irrespective of why, how, or by whom they are used. The Cult of Pharmacology is a bold and necessary new account of America’s complex relationship with drugs.

You owe it to yourself to read this book before you choose a medical specialty!

The Ultimate Guide to Choosing a Medical Specialty, 3rd edition delivers a well-researched, insider’s look at the complex issues medical students face when choosing a medical specialty. Supported by first-hand knowledge, useful facts and statistics – plus the author’s personal experience and gut-level reports from current residents -- this unique guide provides everything necessary to compare specialties and make a confident decision.

The Ultimate Guide to Choosing a Medical Specialty, 3rd edition is divided into two sections: Part 1 Planning Your Medical Career delves into the main issues surrounding the choice of your medical specialty. These twelve chapters provide everything you need to begin making this major decision – from how to research each specialty to how to apply for residency. Part 2 Specialty Profiles features chapters devoted to each of the 20 major specialties. It provides important information such as the latest salary information, employment data, and match statistics.

Features:

An “insider’s look” at different areas of medicine -- with specialty chapters written by physicians just out of residency training Candid and revealing descriptions of each specialty Profiles of the major specialties, including those to which you may have had little exposure, such as radiation oncology A concise, up-to-date guide to the residency application and matching process A chapter with valuable advice to help you maximize your success in obtaining a residency position in each field Updated to include alternative career paths for MDs, such as laboratory science, the military, MD/MBA, and MD/JD
REA's PTCE (Pharmacy Technician Certification Exam) Flashcard Book
Updated Second Edition

500 Questions & Answers You Need to Know

This latest addition to our Health Sciences series of flashcards is designed to help PTCE candidates check their test-readiness before taking the Pharmacy Technician Certification Exam. Unlike most flashcards that come in a box, our cards are bound in an easy-to-use, organized book that makes it convenient to study anywhere.

Written by a seasoned pharmacy technician instructor and based on the most recent exam, our study supplement covers everything you need to know for the PTCE: assisting the pharmacist in serving patients, maintaining medication and inventory control systems, and participating in the management of pharmacy practice.

The flashcards are broken down by PTCE test topics and include multiple-choice questions with detailed answer explanations. The questions are similar to what you may encounter on the PTCE. The 500 flashcards are divided as follows:

* 200 flashcards focused on the top 200 brand/generic drug names including their respective drug classes, indications, side effects, and special considerations

* 50 flashcards focused on pharmaceutical terms and abbreviations

* 250 flashcards focused on PTCE review material:

- 165 flashcards on Assisting the Pharmacist in Serving Patients

- 55 flashcards on Maintaining Medication and Inventory Control Systems

- 30 flashcards on Participating in the Administration and Management of Pharmacy Practice

After studying with the book, go online and review what you have learned at REA's Study Center. Our customizable e-flashcards and 3 practice quizzes give you the freedom to create your own PTCE study plan and study anywhere, anytime. You can also create your own unique flashcards for any sections of the test that give you difficulty.

This flashcard book and the online tools that come with it, will help you personalize your PTCE prep by testing your understanding, pinpointing your weaknesses, and delivering flashcard study materials unique to you.

If you're a pharmacy tech student and want extra practice and review before the exam, REA's PTCE Flashcard Book is the right Rx for your study needs.
FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise and jargon-free text demystifies the inner workings of the US Food and Drug Administration (FDA) and facilitates an understanding of how the agency operates with respect to compliance and product approval, including clinical trial exemptions, fast track status, advisory committee procedures, and more.

The Third Edition of this highly successful publication:

Examines the harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations on human drug, biologics and device development, research, manufacturing, and marketing Includes contributions from experts at organizations such as the FDA, National Institutes of Health (NIH), and PAREXEL Focuses on the new drug application (NDA) process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements Provides updates to the FDA Safety and Innovation Act (FDASIA), incorporating pediatric guidelines and follow-on biologics regulations from the 2012 Prescription Drug User Fee Act (PDUFA) V Explains current FDA inspection processes, enforcement options, and how to handle FDA meetings and required submissions

Co-edited by an industry leader (Mantus) and a respected academic (Pisano), FDA Regulatory Affairs, Third Edition delivers a compilation of the selected US laws and regulations as well as a straightforward commentary on the FDA product approval process that’s broadly useful to both business and academia.

In recent years, the field of pharmaceutical microbiology has experienced numerous technological advances, accompanied by the publication of new and harmonized compendial methods. It is therefore imperative for those who are responsible for monitoring the microbial quality of pharmaceutical/biopharmaceutical products to keep abreast of the latest changes. Microbial Limit and Bioburden Tests: Validation Approaches and Global Requirements guides readers through the various microbiological methods listed in the compendia with easy-to-follow diagrams and approaches to validations of such test methodologies.

Includes New and Updated Material

Now in its second edition, this work is the culmination of research and discussions with technical experts, as well as USP and FDA representatives on various topics of interest to the pharmaceutical microbiologist and those responsible for the microbial quality of products, materials, equipment, and manufacturing facilities. New in this edition is an entire chapter dedicated to the topic of biofilms and their impact on pharmaceutical and biopharmaceutical operations. The subject of rapid methods in microbiology has been expanded and includes a discussion on the validation of alternative microbiological methods and a case study on microbial identification in support of a product contamination investigation.

Substantially updated and revised, this book assists readers in understanding the fundamental issues associated with pharmaceutical microbiology and provides them with tools to create effective microbial contamination control and microbial testing programs for the areas under their responsibility.

 Nurse prescribers are now practising within every discipline of nursing and midwifery, both in the community and the hospital setting. This much-needed book is aimed particularly at students on a non-medical prescribing (NMP) course as well as those nurses who are studying for their community practitioner non-medical prescribing qualification as part of the specialist practice programme. The book is also a useful resource for nursing students and registered nurses who administer and/or prescribe medicines. 


The authors offer a basic introduction to pharmacological concepts, embedded in specific conditions, through case studies and self-assessment questions. By utilising a case study approach, they enable the reader to link pharmacological concepts with clinical practice. 


Many of the conditions presented will be seen across all healthcare settings. In addition, the comprehensive glossary and list of abbreviations will enable students to understand some of the more technical terms used in the British National Formulary (BNF) and other prescribing sources. 

Reading this book, and carrying out the numerous self-assessment activities, will give the reader an appreciation of the value of having a sound pharmacological knowledge base in order to deliver safe practice, effective prescribing and improved patient care.


Contents include:


Introduction  

How the body affects drugs  

How drugs affect the body

Types of adverse drug reactions and interactions 

Understanding and using the British National Formulary

Adherence

Children

Stable angina

Hypertension

Heart failure

Chronic obstructive pulmonary disease 

Neurological problems

Gastrointestinal disorders

Incontinence in adults

Diabetes

Mental health problems

Eye problems

Complex health needs and polypharmacy

Palliative care

The challenges of non-medical prescribing

"The publication of the second edition of this manual comes at an important juncture in the history of clinical research. As advances in information technology make it possible to link individuals and groups in diverse locations in jointly seeking the answers to pressing global health problems, it is critically important to remain vigilant about moral and ethical safeguards for every patient enrolled in a trial. Those who study this manual will be well aware of how to ensure patient safety along with fiscal responsibility, trial efficiency, and research integrity."
—Robert Harrington, Professor of Medicine, Director, Duke Clinical Research Institute, Durham, North Carolina, USA

The Duke Clinical Research Institute (DCRI) is one of the world's leading academic clinical research organizations; its mission is to develop and share knowledge that improves the care of patients around the world through innovative clinical research. This concise handbook provides a practical "nuts and bolts" approach to the process of conducting clinical trials, identifying methods and techniques that can be replicated at other institutions and medical practices.

Designed for investigators, research coordinators, CRO personnel, students, and others who have a desire to learn about clinical trials, this manual begins with an overview of the historical framework of clinical research, and leads the reader through a discussion of safety concerns and resulting regulations. Topics include Good Clinical Practice, informed consent, management of subject safety and data, as well as monitoring and reporting adverse events.

Updated to reflect recent regulatory and clinical developments, the manual reviews the conduct of clinical trials research in an increasingly global context. This new edition has been further expanded to include:

In-depth information on conducting clinical trials of medical devices and biologics The role and responsibilities of Institutional Review Boards, and Recent developments regarding subject privacy concerns and regulations.

Ethical documents such as the Belmont Report and the Declaration of Helsinki are reviewed in relation to all aspects of clinical research, with a discussion of how researchers should apply the principles outlined in these important documents. This graphically appealing and eminently readable manual also provides sample forms and worksheets to facilitate data management and regulatory record retention; these can be modified and adapted for use at investigative sites.

The management of clinical data, from its collection during a trial to its extraction for analysis, has become a critical element in the steps to prepare a regulatory submission and to obtain approval to market a treatment. Groundbreaking on its initial publication nearly fourteen years ago, and evolving with the field in each iteration since then, the third edition of Practical Guide to Clinical Data Management includes important updates to all chapters to reflect the current industry approach to using electronic data capture (EDC) for most studies.

See what’s new in the Third Edition:

A chapter on the clinical trial process that explains the high level flow of a clinical trial from creation of the protocol through the study lock and provides the context for the clinical data management activities that follow Reorganized content reflects an industry trend that divides training and standard operating procedures for clinical data management into the categories of study startup, study conduct, and study closeout Coverage of current industry and Food and Drug Administration (FDA) approaches and concerns

The book provides a comprehensive overview of the tasks involved in clinical data management and the computer systems used to perform those tasks. It also details the context of regulations that guide how those systems are used and how those regulations are applied to their installation and maintenance.

Keeping the coverage practical rather than academic, the author hones in on the most critical information that impacts clinical trial conduct, providing a full end-to-end overview or introduction for clinical data managers.

The most authoritative, comprehensive, and current cardiac surgery resource – completely updated and in full color

DVD with surgical video clips

In Cardiac Surgery in the Adult, 4e the world’s foremost cardiovascular surgeons and physicians deliver thorough, up-to-date coverage of operative strategy, decision-making, technique, and pre and postoperative management for treating the adult cardiac patient.

Editor Lawrence H. Cohn takes you through the optimal treatment of congenital, acquired, infectious, and traumatic diseases of the heart and great vessels. The book begins with a history of cardiac surgery and basic cardiac science, then moves into all types of cardiac surgery, providing both practicing surgeons and residents insight into the very latest surgical protocols.

Presented in full color for the first time, the fourth edition of Cardiac Surgery in the Adult is aligned with up-to-the-minute developments in the field including recent surgical trends in minimally invasive cardiac surgery. Unparalleled in both scope and clinical rigor, the fourth edition contains 70 chapters that highlight every important topic in cardiovascular surgery.

FEATURES

An update of the most recent surgical perspectives and techniques in ischemic and valvular heart disease, diseases of the great vessels, cardiac arrhythmias, and more New and refreshed content on pivotal trends and topics, including the use of robotic surgery, minimally invasive valve and coronary artery bypass surgery, stem-cell induced regenerative medicine, tissue engineering, and percutaneous valve procedures and much more New full-color design—with many illustrations enhanced expressly for this edition—facilitates the comprehension of surgical procedures throughout Important opening section on the fundamentals of cardiac surgery, from its origins to the surgical anatomy of the heart, cardiac surgical physiology, risk stratification, and the statistical treatment of surgical outcome data Key chapters on the perioperative and postoperative management of cardiac patients from internationally recognized experts in the field Coverage of trends that highlight patient demographics, with a focus cross-training surgeons in endovascular skills through coverage of such topics as percutaneous intervention and endovascular graft technology Companion DVD with procedure-simplifying video clips
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