Good Clinical Practice eRegs & Guides - For Your Reference Book 5

Good Clinical Practice eRegs & Guides - For Your Reference Book

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Good Clinical Practice eRegs & Guides provides a
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: 


 



Good Clinical Practice For Your Reference - Book 5 

ICH - Efficacy Guidelines E3 – E15 



ICH-E3: Clinical Study Reports ICH-E3 -
Structure and Content of Clinical Study Reports 




ICH-E4: Dose-Response Information to Support
Drug Registration 




ICH-E5: Ethnic Factors in the Acceptability of
foreign Clinical Data 




ICH-E6: Guideline for Good Clinical Practice 



ICH-E7: Studies in Support of Special
Populations: Geriatrics 




ICH-E8: General Considerations for Clinical
Trials 




ICH-E9: Statistical Principles for Clinical
Trials 




ICH E-10: Choice of Control Group and Related
Issues in Clinical Trials 




ICH-E11: Clinical Investigation of Medicinal
Products in the Pediatric Population 




ICH-E12: Draft ICH Consensus Principle
Principles for Clinical Evaluation of New Antihypertensive Drugs 




ICH-E14: The Clinical Evaluation of QT/QTc
Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs 




ICH-E15: Definitions for Genomic Biomarkers,
Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories



 



 

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eregs & guides
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204
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Language
English
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Genres
Business & Economics / Industries / Pharmaceutical & Biotechnology
Fiction / Medical
Medical / General
Science / Biotechnology
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An instant New York Times and indie bestseller, Dopesick is the only book to fully chart the devastating opioid crisis in America: "a harrowing, deeply compassionate dispatch from the heart of a national emergency" (New York Times) from a bestselling author and journalist who has lived through it
In this masterful work, Beth Macy takes us into the epicenter of America's twenty-plus year struggle with opioid addiction. From distressed small communities in Central Appalachia to wealthy suburbs; from disparate cities to once-idyllic farm towns; it's a heartbreaking trajectory that illustrates how this national crisis has persisted for so long and become so firmly entrenched.
Beginning with a single dealer who lands in a small Virginia town and sets about turning high school football stars into heroin overdose statistics, Macy endeavors to answer a grieving mother's question-why her only son died-and comes away with a harrowing story of greed and need. From the introduction of OxyContin in 1996, Macy parses how America embraced a medical culture where overtreatment with painkillers became the norm. In some of the same distressed communities featured in her bestselling book Factory Man, the unemployed use painkillers both to numb the pain of joblessness and pay their bills, while privileged teens trade pills in cul-de-sacs, and even high school standouts fall prey to prostitution, jail, and death.
Through unsparing, yet deeply human portraits of the families and first responders struggling to ameliorate this epidemic, each facet of the crisis comes into focus. In these politically fragmented times, Beth Macy shows, astonishingly, that the only thing that unites Americans across geographic and class lines is opioid drug abuse. But in a country unable to provide basic healthcare for all, Macy still finds reason to hope-and signs of the spirit and tenacity necessary in those facing addiction to build a better future for themselves and their families.
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In this astonishing and startling book, award-winning science and history writer Robert Whitaker investigates a medical mystery: Why has the number of disabled mentally ill in the United States tripled over the past two decades? Every day, 1,100 adults and children are added to the government disability rolls because they have become newly disabled by mental illness, with this epidemic spreading most rapidly among our nation’s children. What is going on?
 
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Then comes the scientific query at the heart of this book: During the past fifty years, when investigators looked at how psychiatric drugs affected long-term outcomes, what did they find? Did they discover that the drugs help people stay well? Function better? Enjoy good physical health? Or did they find that these medications, for some paradoxical reason, increase the likelihood that people will become chronically ill, less able to function well, more prone to physical illness?
 
This is the first book to look at the merits of psychiatric medications through the prism of long-term results. Are long-term recovery rates higher for medicated or unmedicated schizophrenia patients? Does taking an antidepressant decrease or increase the risk that a depressed person will become disabled by the disorder? Do bipolar patients fare better today than they did forty years ago, or much worse? When the National Institute of Mental Health (NIMH) studied the long-term outcomes of children with ADHD, did they determine that stimulants provide any benefit?
 
By the end of this review of the outcomes literature, readers are certain to have a haunting question of their own: Why have the results from these long-term studies—all of which point to the same startling conclusion—been kept from the public?
 
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