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Author: Richard Kay
Publisher: John Wiley & Sons
ISBN: 1119867401
Category : Medical
Languages : en
Pages : 436
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Book Description
STATISTICAL THINKING FOR NON-STATISTICIANS IN DRUG REGULATION Statistical methods in the pharmaceutical industry are accepted as a key element in the design and analysis of clinical studies. Increasingly, the medical and scientific community are aligning with the regulatory authorities and recognizing that correct statistical methodology is essential as the basis for valid conclusions. In order for those correct and robust methods to be successfully employed there needs to be effective communication across disciplines at all stages of the planning, conducting, analyzing and reporting of clinical studies associated with the development and evaluation of new drugs and devices. Statistical Thinking for Non-Statisticians in Drug Regulation provides a comprehensive in-depth guide to statistical methodology for pharmaceutical industry professionals, including physicians, investigators, medical science liaisons, clinical research scientists, medical writers, regulatory personnel, statistical programmers, senior data managers and those working in pharmacovigilance. The author’s years of experience and up-to-date familiarity with pharmaceutical regulations and statistical practice within the wider clinical community make this an essential guide for the those working in and with the industry. The third edition of Statistical Thinking for Non-Statisticians in Drug Regulation includes: A detailed new chapter on Estimands in line with the 2019 Addendum to ICH E9 Major new sections on topics including Combining Hierarchical Testing and Alpha Adjustment, Biosimilars, Restricted Mean Survival Time, Composite Endpoints and Cumulative Incidence Functions, Adjusting for Cross-Over in Oncology, Inverse Propensity Score Weighting, and Network Meta-Analysis Updated coverage of many existing topics to reflect new and revised guidance from regulatory authorities and author experience Statistical Thinking for Non-Statisticians in Drug Regulation is a valuable guide for pharmaceutical and medical device industry professionals, as well as statisticians joining the pharmaceutical industry and students and teachers of drug development.
Author: Jessica Kensky
Publisher: National Geographic Books
ISBN: 0763696048
Category : Juvenile Fiction
Languages : en
Pages : 0
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Book Description
A 2019 Schneider Family Book Award Winner Based on a real-life partnership, the heartening story of the love and teamwork between a girl and her service dog will illuminate and inspire. Rescue thought he’d grow up to be a Seeing Eye dog — it’s the family business, after all. When he gets the news that he’s better suited to being a service dog, he’s worried that he’s not up to the task. Then he meets Jessica, a girl whose life is turning out differently than the way she'd imagined it, too. Now Jessica needs Rescue by her side to help her accomplish everyday tasks. And it turns out that Rescue can help Jessica see after all: a way forward, together, one step at a time. An endnote from the authors tells more about the training and extraordinary abilities of service dogs, particularly their real-life best friend and black lab, Rescue.
Author: Annahita Parsan
Publisher: Thomas Nelson
ISBN: 9781400207510
Category :
Languages : en
Pages : 288
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Book Description
There will be pain ahead, and trouble and problems that I won't be able to fix on my own. But in them all, I know God will be there, calling me to look to him. Inviting me to take the next step toward his open arms. And I will say yes. And yes. And yes. Annahita Parsan was born into a Muslim family in Iran and grew up with the simple hope of one day finding a good husband, having children, and doing some good in the world. Married and a mother before she turned eighteen, Annahita found herself unexpectedly widowed and trapped for years in an abusive second marriage that she later fled-discovering instead a God who might love her. Stranger No More is the remarkable true story of Annahita's path from oppression to the life-changing hope of Jesus. Fleeing Iran across the mountains into Turkey, she spent months in the terrifying Agri prison before a miraculous release and flight to Europe, where she and her two children knelt in a church and prayed, "God, from this day on we are Christians." Filled with unthinkable circumstances, miraculous rescues, and the quietly constant voice of Jesus, Stranger No More leads readers deep into the heart of God and draws them toward the same call that Annahita heeds today: using her past to save others from theirs. As the leader of two congregations in Sweden, Annahita has baptized hundreds of former Muslims since her own conversion, has seen firsthand the powerful ways God is at work among those who have left Islam behind, and is reminded every day that saying yes to God is always worth the risk.
Author: Richard Kay
Publisher: John Wiley & Sons
ISBN: 1119867401
Category : Medical
Languages : en
Pages : 436
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Book Description
STATISTICAL THINKING FOR NON-STATISTICIANS IN DRUG REGULATION Statistical methods in the pharmaceutical industry are accepted as a key element in the design and analysis of clinical studies. Increasingly, the medical and scientific community are aligning with the regulatory authorities and recognizing that correct statistical methodology is essential as the basis for valid conclusions. In order for those correct and robust methods to be successfully employed there needs to be effective communication across disciplines at all stages of the planning, conducting, analyzing and reporting of clinical studies associated with the development and evaluation of new drugs and devices. Statistical Thinking for Non-Statisticians in Drug Regulation provides a comprehensive in-depth guide to statistical methodology for pharmaceutical industry professionals, including physicians, investigators, medical science liaisons, clinical research scientists, medical writers, regulatory personnel, statistical programmers, senior data managers and those working in pharmacovigilance. The author’s years of experience and up-to-date familiarity with pharmaceutical regulations and statistical practice within the wider clinical community make this an essential guide for the those working in and with the industry. The third edition of Statistical Thinking for Non-Statisticians in Drug Regulation includes: A detailed new chapter on Estimands in line with the 2019 Addendum to ICH E9 Major new sections on topics including Combining Hierarchical Testing and Alpha Adjustment, Biosimilars, Restricted Mean Survival Time, Composite Endpoints and Cumulative Incidence Functions, Adjusting for Cross-Over in Oncology, Inverse Propensity Score Weighting, and Network Meta-Analysis Updated coverage of many existing topics to reflect new and revised guidance from regulatory authorities and author experience Statistical Thinking for Non-Statisticians in Drug Regulation is a valuable guide for pharmaceutical and medical device industry professionals, as well as statisticians joining the pharmaceutical industry and students and teachers of drug development.
Author:
Publisher:
ISBN:
Category : Delegated legislation
Languages : en
Pages : 2224
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Book Description
Author: George Galdorisi
Publisher: Zenith Press
ISBN: 9780760323922
Category : History
Languages : en
Pages : 672
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Book Description
The history of a near-century of combat search and rescue, with an account of how the discipline was created and how it is administered—or neglected—today.
Author: SriniVas R. Sadda
Publisher: Elsevier Health Sciences
ISBN: 0323722148
Category : Medical
Languages : en
Pages : 2949
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Book Description
Through six outstanding and award-winning editions, Ryan's Retina has offered unsurpassed coverage of this complex subspecialty—everything from basic science through the latest research, therapeutics, technology, and surgical techniques. The fully revised 7th Edition, edited by Drs. SriniVas R. Sadda, Andrew P. Schachat, Charles P. Wilkinson, David R. Hinton, Peter Wiedemann, K. Bailey Freund, and David Sarraf, continues the tradition of excellence, balancing the latest scientific research and clinical correlations and covering everything you need to know on retinal diagnosis, treatment, development, structure, function, and pathophysiology. More than 300 global contributors share their knowledge and expertise to create the most comprehensive reference available on retina today. - Features sweeping content updates, including new insights into the fundamental pathogenic mechanisms of age-related macular degeneration, advances in imaging including OCT angiography and intraoperative OCT, new therapeutics for retinal vascular disease and AMD, novel immune-based therapies for uveitis, and the latest in instrumentation and techniques for vitreo-retinal surgery. - Includes five new chapters covering Artificial Intelligence and Advanced Imaging Analysis, Pachychoroid Disease and Its Association with Polypoidal Choroidal Vasculopathy, Retinal Manifestations of Neurodegeneration, Microbiome and Retinal Disease, and OCT-Angiography. - Includes more than 50 video clips (35 new to this edition) highlighting the latest surgical techniques, imaging guidance, and coverage of complications of vitreoretinal surgery. New videos cover Scleral Inlay for Recurrent Optic Nerve Pit Masculopathy, Trauma with Contact Lens, Recurrent Retinal Detachment due to PVR, Asteroid Hyalosis, and many more. - Contains more than 2,000 high-quality images (700 new to this edition) including anatomical illustrations, clinical and surgical photographs, diagnostic imaging, decision trees, and graphs. - Enhanced eBook version included with purchase. Your enhanced eBook allows you to access all of the text, figures, and references from the book on a variety of devices.
Author: James T. Tweedy
Publisher: CRC Press
ISBN: 1420025465
Category : Business & Economics
Languages : en
Pages : 814
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Book Description
Surpassing the standard set by the first edition, Healthcare Hazard Control and Safety Management, Second Edition presents expansive coverage for healthcare professionals serving in safety, occupational health, hazard materials management, quality improvement, and risk management positions. Comprehensive in scope, the book covers all major issues i
Author: Irving Abella
Publisher: University of Toronto Press
ISBN: 1442663855
Category : History
Languages : en
Pages : 375
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Book Description
Winner of the National Jewish Book Award (Holocaust Category) Winner of the Canadian Historical Association John A. Macdonald Prize Featured in The Literary Review of Canada 100: Canada’s Most Important Books [This] is a story best summed up in the words of an anonymous senior Canadian official who, in the midst of a rambling, off-the-record discussion with journalists in 1945, was asked how many Jews would be allowed into Canada after the war … ‘None,’ he said, ‘is too many.’ From the Preface One of the most significant studies of Canadian history ever written, None Is Too Many conclusively lays to rest the comfortable notion that Canada has always been an accepting and welcoming society. Detailing the country’s refusal to offer aid, let alone sanctuary, to Jews fleeing Nazi persecution between 1933 and 1948, it is an immensely bleak and discomfiting story – and one that was largely unknown before the book’s publication. Irving Abella and Harold Troper’s retelling of this episode is a harrowing read not easily forgotten: its power is such that, ‘a manuscript copy helped convince Ron Atkey, Minister of Employment and Immigration in Joe Clark’s government, to grant 50,000 “boat people” asylum in Canada in 1979, during the Southeast Asian refugee crisis’ (Robin Roger, The Literary Review of Canada). None Is Too Many will undoubtedly continue to serve as a potent reminder of the fragility of tolerance, even in a country where it is held as one of our highest values.
Author: Reginald Campbell
Publisher: CRC Press
ISBN: 100011497X
Category : Science
Languages : en
Pages : 468
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Book Description
This book evolved from the course developed at the U.S. Department of Labor's National Mine, Health, and Safety Academy to develop the legislation that eventually became 29 CFR 1910.120. Fundamentals of Hazardous Materials Incidents offers the reader a basic understanding of the principles involved in toxicology, federal regulations, respiratory protection, personal protective equipment, radiation, environmental considerations, industrial hygiene sampling, site safety, and chemically resistant suits. Thousands of people have been trained using this manual, now revised and available for the first time in hardcover format. The book is essential for identifying potential problems at hazardous waste sites, covers diverse topics throughout the area of hazardous materials response, and is ideal for training courses to meet 29 CFR 1910.120 requirements. Quantity discounts available.
Author:
Publisher:
ISBN:
Category : Engineering
Languages : en
Pages : 552
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Book Description
Since its creation in 1884, Engineering Index has covered virtually every major engineering innovation from around the world. It serves as the historical record of virtually every major engineering innovation of the 20th century. Recent content is a vital resource for current awareness, new production information, technological forecasting and competitive intelligence. The world?s most comprehensive interdisciplinary engineering database, Engineering Index contains over 10.7 million records. Each year, over 500,000 new abstracts are added from over 5,000 scholarly journals, trade magazines, and conference proceedings. Coverage spans over 175 engineering disciplines from over 80 countries. Updated weekly.
