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Clinical Trials And Tribulations

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Clinical Drug Trials and Tribulations Revised and Expanded Second Edition

Clinical Drug Trials and Tribulations  Revised and Expanded  Second Edition Book
Author : Allen Cato,Lynda Sutton,Allen Cato III
Publisher : CRC Press
Release : 2002-03-26
ISBN : 0824744802
Language : En, Es, Fr & De

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Book Description :

Aimed at those already involved in drug development or those considering entering the field, Clinical Drug Trials and Tribulations, Second Edition comprehensibly addresses the new, day-to-day challenges of drug development with valuable assessments of the areas affecting the conduction of nonclinical and clinical studies. Addressing which decisions should be made during drug development, this updated and expanded text/reference carefully guides readers through the various trials and tribulations that emerge phase-by-phase and are pertinent to all levels of pharmaceutical or clinical drug management. Bringing together the latest information on drug development, the Second Edition contains: new material on... international regulation and deregulation venture capitalist investment the IND process informed consent changes in manufacturing and updated and extended coverage of... pediatric drug trial design the advantages and disadvantages of orphan drug designations the maximization of package inserts for marketing post approval safety surveillance withdrawals from the drug market Clinical Drug Trials and Tribulations, Second Edition will prove an invaluable reference for pharmacologists, pharmacists, clinical chemists, clinical coordinators, clinical monitors, government drug regulatory personnel, and bioethicists as well as a useful text for medical or pharmacy school courses on pharmaceutical development and research.

Clinical Drug Trials and Tribulations

Clinical Drug Trials and Tribulations Book
Author : Allen E. Cato
Publisher : Marcel Dekker Incorporated
Release : 1988
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

A reference for pharmacologists, pharmacists, clinical chemists, drug regulators, and bioethicists, and a text for medical or pharmacy courses on drug development. The contributors address such topics as clinical drug development planning, causality in single-event drug reactions, pediatric drug tri

Clinical Drug Trials and Tribulations Revised and Expanded Second Edition

Clinical Drug Trials and Tribulations  Revised and Expanded  Second Edition Book
Author : Allen Cato,Lynda Sutton,Allen Cato III
Publisher : CRC Press
Release : 2002-03-26
ISBN : 9780824703141
Language : En, Es, Fr & De

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Book Description :

Aimed at those already involved in drug development or those considering entering the field, Clinical Drug Trials and Tribulations, Second Edition comprehensibly addresses the new, day-to-day challenges of drug development with valuable assessments of the areas affecting the conduction of nonclinical and clinical studies. Addressing which decisions should be made during drug development, this updated and expanded text/reference carefully guides readers through the various trials and tribulations that emerge phase-by-phase and are pertinent to all levels of pharmaceutical or clinical drug management. Bringing together the latest information on drug development, the Second Edition contains: new material on... international regulation and deregulation venture capitalist investment the IND process informed consent changes in manufacturing and updated and extended coverage of... pediatric drug trial design the advantages and disadvantages of orphan drug designations the maximization of package inserts for marketing post approval safety surveillance withdrawals from the drug market Clinical Drug Trials and Tribulations, Second Edition will prove an invaluable reference for pharmacologists, pharmacists, clinical chemists, clinical coordinators, clinical monitors, government drug regulatory personnel, and bioethicists as well as a useful text for medical or pharmacy school courses on pharmaceutical development and research.

Clinical Drug Trials and Tribulations Revised and Expanded Second Edition

Clinical Drug Trials and Tribulations  Revised and Expanded  Second Edition Book
Author : Allen Cato,Lynda Sutton,Allen Cato III
Publisher : CRC Press
Release : 2002-03-26
ISBN : 9781135556730
Language : En, Es, Fr & De

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Book Description :

Aimed at those already involved in drug development or those considering entering the field, Clinical Drug Trials and Tribulations, Second Edition comprehensibly addresses the new, day-to-day challenges of drug development with valuable assessments of the areas affecting the conduction of nonclinical and clinical studies. Addressing which decisions should be made during drug development, this updated and expanded text/reference carefully guides readers through the various trials and tribulations that emerge phase-by-phase and are pertinent to all levels of pharmaceutical or clinical drug management. Bringing together the latest information on drug development, the Second Edition contains: new material on... international regulation and deregulation venture capitalist investment the IND process informed consent changes in manufacturing and updated and extended coverage of... pediatric drug trial design the advantages and disadvantages of orphan drug designations the maximization of package inserts for marketing post approval safety surveillance withdrawals from the drug market Clinical Drug Trials and Tribulations, Second Edition will prove an invaluable reference for pharmacologists, pharmacists, clinical chemists, clinical coordinators, clinical monitors, government drug regulatory personnel, and bioethicists as well as a useful text for medical or pharmacy school courses on pharmaceutical development and research.

Trials and Tribulations

Trials and Tribulations Book
Author : Scott D. Halpern
Publisher : Unknown
Release : 2002
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Trials and Tribulations book written by Scott D. Halpern, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Clinical Trials and Their Tribulations

Clinical Trials and Their Tribulations Book
Author : Helen Spiby
Publisher : Unknown
Release : 1998
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Clinical Trials and Their Tribulations book written by Helen Spiby, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Palliative Care Trials and COVID 19 Tribulations

Palliative Care  Trials and COVID 19 Tribulations Book
Author : Cheng Hoon Chew,Yan Yee Yip,Syahirah Farhana Mohd Saleh,Khairul Nisa’ Ishak,Anis Suraya Muhamad Nawawai,Chun Keat Chew,Ting Soo Chow,Richard Boon Leong Lim,Bak Leong Goh,Pik Pin Goh,Kalaiarasu M. Peariasamy
Publisher : Institute for Clinical Research, NIH, Malaysia
Release : 2021-09-09
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

The COVID-19 pandemic started more than a year ago, but until today, we did not have a definitive cure for this disease. The SARS-CoV-2 virus constantly mutated over time, infecting more people and causing tremendous stress on the existing scarcity of healthcare resources all around the world. Here, the experts from ground zero will share their first-hand experience of clinical trials looking for a cure for COVID-19, like the WHO's Solidarity Trial and the role of palliative care in COVID-19 as part of humanitarian crisis management.

Working In Clinical Research A Personal Story

Working In Clinical Research   A Personal Story Book
Author : Liam Mistry
Publisher : Unknown
Release : 2021-04-03
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

The author describes his personal journey working in different clinical research environments and highlights his trials and tribulations so far within the industry. He also shares his views on working as a Clinical Research Associate and his experience of healthcare in the community. Furthermore he provides a spin on where he thinks the industry is heading in future and the importance of the patient in clinical trials.You could benefit from this book if: You want a unique insight into clinical research. You aspire to join the industry. You want top tips and useful information

My Migraine Story From Darkened Room to Writer

My Migraine Story   From Darkened Room to Writer  Book
Author : T. Stedman
Publisher : Unknown
Release : 2018-01-20
ISBN : 9780993309861
Language : En, Es, Fr & De

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Book Description :

More than a list of common triggers and remedies, My Migraine Story, is an emotionally candid personal account, learned through trial and error and bitter experience. A concise and detailed log of how she set herself free.

Oncology Clinical Trials

Oncology Clinical Trials Book
Author : Susan Halabi, PhD,Wm. Kevin Kelly, DO
Publisher : Demos Medical Publishing
Release : 2009-12-22
ISBN : 9781935281764
Language : En, Es, Fr & De

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Book Description :

Clinical trials are the engine of progress in the development of new drugs and devices for the detection, monitoring, prevention and treatment of cancer. A well conceived, carefully designed and efficiently conducted clinical trial can produce results that change clinical practice overnight, deliver new oncology drugs and diagnostics to the marketplace, and expand the horizon of contemporary thinking about cancer biology. A poorly done trial does little to advance the field or guide clinical practice, consumes precious clinical and financial resources and challenges the validity of the ethical contract between investigators and the volunteers who willingly give their time and effort to benefit future patients. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, Oncology Clinical Trials, provides a comprehensive guide for both early-career and senior oncology investigators into the successful design, conduct and analysis of an oncology clinical trial. Oncology Clinical Trials covers how to formulate a study question, selecting a study population, study design of Phase I, II, and III trials, toxicity monitoring, data analysis and reporting, use of genomics, cost-effectiveness analysis, systemic review and meta-analysis, and many other issues. Many examples of real-life flaws in clinical trials that have been reported in the literature are included throughout. The book discusses clinical trials from start to finish focusing on real-life examples in the development, design and analysis of clinical trials. Oncology Clinical Trials features: A systematic guide to all aspects of the design, conduct, analysis, and reporting of clinical trials in oncology Contributions from oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives Hot topics in oncology trials including multi-arm trials, meta-analysis and adaptive design, use of genomics, and cost-effectiveness analysis Real-life examples from reported clinical trials included throughout

Clinical Trials in Psychiatry

Clinical Trials in Psychiatry Book
Author : Brian S. Everitt,Simon Wessely
Publisher : John Wiley & Sons
Release : 2008-04-15
ISBN : 9780470723845
Language : En, Es, Fr & De

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Book Description :

At last – a new edition of the highly acclaimed book Clinical Trials in Psychiatry This book provides a concise but thorough overview of clinical trials in psychiatry, invaluable to those seeking solutions to numerous problems relating to design, methodology and analysis of such trials. Practical examples and applications are used to ground theory whenever possible. The Second Edition includes new information regarding: Recent important psychiatric trials More specific discussion of psychiatry in the USA and the particular problems of trials in the USA, including comments about the FDA (U.S. Food and Drug Administration) An extended chapter on meta-analysis Further discussion of sub-group analysis Special features include appendices outlining how to design and report clinical trials, what websites and software programs are appropriate and an extensive reference section. From the reviews of the First Edition: “Everitt & Wessely are to be congratulated on producing an excellent guide to help overcome the snags in clinical trial research. Clearly written and in an engrossing style, the book is likely to become a classic textbook on clinical trials, and not just in psychiatry. The authors’ enthusiasm and grasp of clinical trial research make for a gripping and insightful read...it is one of the very best books that has been written on clinical trials.” THE BRITISH JOURNAL OF PSYCHIATRY "The experience of both authors in this area gives the book a very pragmatic approach grounded in reality, with theoretical overviews invariably being followed by practical examples and applications... an invaluable companion to anyone involved in, or contemplating undertaking, clinical trials research.” PSYCHOLOGICAL MEDICINE

Double Standards in Medical Research in Developing Countries

Double Standards in Medical Research in Developing Countries Book
Author : Ruth Macklin
Publisher : Cambridge University Press
Release : 2004-05-27
ISBN : 9780521541701
Language : En, Es, Fr & De

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Book Description :

Recent international developments show that essential medications can be made affordable and accessible to developing countries, and that double standards need not prevail. This is the first book to examine these issues, drawing the bold conclusion that double standards in medical research are ethically unacceptable."--BOOK JACKET.

Clinical Trials

Clinical Trials Book
Author : Stuart J. Pocock
Publisher : John Wiley & Sons
Release : 2013-07-17
ISBN : 1118794109
Language : En, Es, Fr & De

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Book Description :

This comprehensive, unified text on the principles and practice of clinical trials presents a detailed account of how to conduct the trials. It describes the design, analysis, and interpretation of clinical trials in a non-technical manner and provides a general perspective on their historical development, current status, and future strategy. Features examples derived from the author's personal experience.

Oncology Clinical Trials

Oncology Clinical Trials Book
Author : William Kevin Kelly, DO,Susan Halabi, PhD
Publisher : Springer Publishing Company
Release : 2018-03-28
ISBN : 0826168736
Language : En, Es, Fr & De

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Book Description :

The second edition of Oncology Clinical Trials has been thoroughly revised and updated and now contains the latest designs and methods of conducting and analyzing cancer clinical trials in the era of precision medicine with biologic agents—including trials investigating the safety and efficacy of targeted therapies, immunotherapies, and combination therapies as well as novel radiation therapy modalities. Now divided into six sections this revamped book provides the necessary background and expert guidance from the principles governing oncology clinical trials to the innovative statistical design methods permeating the field; from conducting trials in a safe and effective manner, analyzing and interpreting the data, to a forward-looking assessment and discussion of regulatory issues impacting domestic, international, and global clinical trials. Considered by many as the gold standard reference on oncology clinical trials in the field, the second edition continues to provide examples of real-life flaws and real-world examples for how to successfully design, conduct and analyze quality clinical trials and interpret them. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, this volume provides a comprehensive guide in the design, conduct, monitoring, analysis, and reporting of clinical trials in oncology. NEW TO THIS EDITION: Outlines how to design clinical trials with and without biomarker testing—including genomics-based “basket” trials, and adaptive trials for all phases during treatment and quality-of-life trials Includes new chapters on immunotherapy trials, radiation therapy trials, multi-arm trials, meta-analysis and adaptive design, use of genomics, dose modifications and use of ancillary treatments in investigational studies, establishing surrogate endpoints, practical issues with correlative studies, cost-effectiveness analysis, and more Comprehensively covers all regulatory aspects in the pursuit of global oncology trials Digital access to the ebook included

National Library of Medicine Audiovisuals Catalog

National Library of Medicine Audiovisuals Catalog Book
Author : National Library of Medicine (U.S.)
Publisher : Unknown
Release : 2021-12-04
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download National Library of Medicine Audiovisuals Catalog book written by National Library of Medicine (U.S.), available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Stephens Detection of New Adverse Drug Reactions

Stephens  Detection of New Adverse Drug Reactions Book
Author : John Talbot,Patrick Waller
Publisher : John Wiley & Sons
Release : 2004-11-19
ISBN : 0470092653
Language : En, Es, Fr & De

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Book Description :

A key text for all those involved in pharmacovigilance. Detection of new adverse drug reactions is fundamental to the protection of patients from harm that may occur as a result of medication. This book explores the methods used to investigate new adverse drug reactions, discussing all elements from the scientific background and animal toxicology through to worldwide regulatory and ethical issues. Stephens' Detection of New Adverse Drug Reactions provides comprehensive and up-to-date coverage of material fundamentally important to all those active in the field, whether they work in the pharmaceutical industry, drug regulatory authorities or in academia. The fifth edition of this classic reference work includes new chapters on: vaccine safety surveillance managing drug safety issues with marketed products operational aspects of drug safety function safety of biotechnology products future of pharmacovigilance Reviews of previous editions: "This book surpasses all its educational aims. Not only is the subject matter covered comprehensively but the material is presented in a very user-friendly manner. The editors have succeeded in producing a highly-specific, definitive reference book which doubles as a most enjoyable read." —Commended by the 1999 BMA Medical Book Competition "For anyone entering the field of adverse reaction monitoring one could not wish for a better primer" —International Journal of Risk and Safety in Medicine

Cumulated Index Medicus

Cumulated Index Medicus Book
Author : Anonim
Publisher : Unknown
Release : 1978
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Cumulated Index Medicus book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Novel Therapies in Head and Neck Cancer Beyond the Horizon

Novel Therapies in Head and Neck Cancer  Beyond the Horizon Book
Author : Maie A. St. John,No hee Park
Publisher : Academic Press
Release : 2020-06-29
ISBN : 0128209291
Language : En, Es, Fr & De

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Book Description :

Novel Therapies in Head and Neck Cancer: Beyond the Horizon, Volume Twelve, provides a high-level synthesis of the latest treatments and outcomes relating to head and neck cancer. Chemotherapy and immunotherapy for those cancer types are rapidly evolving, and an updated source based on the expertise of internationally renowned researchers is necessary. This book discusses the outcome of recent trials using chemotherapy, novel approaches for HPV+ SCCA, cases in which immunotherapy is more likely to be successful, and precision medicine based on target therapies. Additionally, new approaches for rare diseases in head and neck and novel drug delivery platforms are presented. This book will be a very useful source so that students, scientists and clinicians who can be facile with the data, build on what is known, and continue to offer cutting-edge, validated therapies to all patients. Covers new chemotherapy trials, specifically on HPV and non-HPV related cancer types Discusses the application of immunotherapy to treat rare types of head and neck cancer Presents updated information on targeted therapies, specifically focusing on skin cancer in the region

Fundamentals of Clinical Trials

Fundamentals of Clinical Trials Book
Author : Lawrence M. Friedman,Curt D. Furberg,David L. DeMets,David M. Reboussin,Christopher B. Granger
Publisher : Springer
Release : 2015-08-27
ISBN : 331918539X
Language : En, Es, Fr & De

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Book Description :

This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise. A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded. Many contemporary clinical trial examples have been added. There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing and international trials. This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients. The authors use numerous examples of published clinical trials to illustrate the fundamentals. The text is organized sequentially from defining the question to trial closeout. One chapter is devoted to each of the critical areas to aid the clinical trial researcher. These areas include pre-specifying the scientific questions to be tested and appropriate outcome measures, determining the organizational structure, estimating an adequate sample size, specifying the randomization procedure, implementing the intervention and visit schedules for participant evaluation, establishing an interim data and safety monitoring plan, detailing the final analysis plan and reporting the trial results according to the pre-specified objectives. Although a basic introductory statistics course is helpful in maximizing the benefit of this book, a researcher or practitioner with limited statistical background would still find most if not all the chapters understandable and helpful. While the technical material has been kept to a minimum, the statistician may still find the principles and fundamentals presented in this text useful.

Success in Academic Surgery Clinical Trials

Success in Academic Surgery  Clinical Trials Book
Author : Timothy M. Pawlik,Julie A. Sosa
Publisher : Springer Science & Business Media
Release : 2013-11-04
ISBN : 1447146794
Language : En, Es, Fr & De

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Book Description :

Surgical education is a rapidly expanding area of surgical research and career interest, and as the Association for Academic Surgery (AAS) Fall Courses (www.aasurg.org) and International courses offer more and more specialty tracking there is a greater need for an accompanying textbook to supplement the material presented in the courses.