Book Description
A comprehensive desk reference, this book provides an easy-to-read guide to the practical skills and methods required by project managers running clinical studies. The author uses a framework based on seven core themes: goals, budgets, time, resources, measurement, communication and training to present a solid review of how modern management theory can be brought to bear on the specialist demands of clinical trials. Coverage includes the R&D process, CROs, the Clinical Study Team, and QA audits. The book includes true-life case histories as well as a comprehensive overview of drug development processes and trends that are driving change. It is a resource for anyone who wishes to sharpen their study management skills.
Book Description
Guide to Clinical Trials is the definitive text and reference that sets the standard in contemporary clinical trial methodology. More than 130 chapters grouped into twelve sections take the reader step by step through every phase of a clinical trial--from planning trials and writing protocols to analyzing data, publishing results, and evaluating published literature. Dr. Spilker's approach is uniquely practical, addressing problems of study design and data interpretation from a clinical, nonmathematical perspective. Another particularly helpful feature of the book is an extensive collection of tables, figures, and checklists.
Customer Reviews:
Good reference for Start-up Companies.......2003-04-03
Working in a small biotech start-up company, I think this book is a great reference especially if you have limited resources and interested in conducting drug development the "right" way. This text covers all areas of drug development and useful for people in regulatory affairs, project management, clinical affairs, and data management.
Mediocre book - full of fluff.......1999-09-23
This is a decent book, but packed with padding. You have to read 50 pages to get 1 page worth of useful information. Spilker is adequately familiar with clinical trials, but his writing style tends to meander a lot.
If you're a complete novice, it may be of use, but you will outgrow it after a few months. And unfortunately, the book is somewhat outdated--clinical trials are much more sophisticated now. I'm not sure what the person below is talking about--using it after 30 years in the industry!?! Anyone who's been in the industry for more than couple of years should know everything there is in this book.
This text is the industry standard........1998-10-20
If you could only have one book on clinical research, this should be the one. It is comprehensive, and presents much of the material in tabular format that greatly facilitates learning. I have been in the drug development business for over 30 years and still refer to this text on a regular basis.
The best guideline book on the subject........1998-10-15
A basic handbook for management of clinical trials. This is a "must" reading for anyone who deals with clinical trials. It covers areas of protocol development, regulatory issues in human clinical trials. There is a detailed section on data collection, handling data and statistical issues.Also an introduction to project management.The book contains a large amount of tables easy to read and with great "tips".
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Conducting GCP- Compliant Clinical Research: A Practical Guide
Wendy Bohaychuk , and
Graham Ball
Manufacturer: Wiley
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ASIN: 0471988243 |
Book Description
Conducting GCP-Compliant Clinical Research Wendy Bohaychuk and Graham Ball Good Clinical Research Practices, UK and Canada The overall aim of this work is to provide a reference book which describes the general framework for conducting GCP-compliant clinical research, particularly pharmaceutical industry clinical research. Wendy Bohaychuk and Graham Ball run a consultancy, GCRP Ltd., which has conducted over 820 GCP audits involving more than 200 companies in the last 10 years. More than 5,000 individuals have been involved in their training courses to help people perform GCP-compliant clinical research. They have authored several books and articles including:
* Standard operating procedures for investigators
* Standard operating procedures for sponsors and CROs
* GCP - an indexed reference
Drawing on their wealth of experience, they have produced this enlightening and practical reference work which fills an educational gap in the understanding of GCP at all levels. Written in concise language simple enough to be accessible to those new in the field, the dozens of real-life stories and detailed case studies at the end of each chapter make the book an invaluable resource for the more experienced, highlighting what can go wrong in a clinical study: A study of prostate cancer in the UK - An investigator brochure was not provided. The company argued that a brochure was unnecessary because the drug was already marketed. Indeed it was - for hypertension! A study of cardiovascular surgery in the UK - The consent dates were changed (by overwriting) to indicate that the patients had provided consent before the study started. The original dates post-dated the start of the study. A study of hypertension in Germany - The investigator brochure predated the study by nine years! Checklists are provided throughout the book to help monitors, auditors and investigators ensure that nothing important is overlooked. The authors present the topic of GCP with remarkable clarity, insight and enthusiasm emphasizing that this code of practice was not designed to make studies more difficult for investigators or more expensive for sponsors and CROs but, in the final analysis, to ensure the safety and well-being of study participants and future patients who will benefit from well-conducted, GCP-compliant studies.
Average customer rating:
- Best Book Available on Lithium Treatment
|
Lithium Treatment of Manic Depressive Illness: A Practical Guide
Mogens Schou
Manufacturer: S. Karger Publishers (USA)
ProductGroup: Book
Binding: Paperback
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ASIN: 3805556675 |
Customer Reviews:
Best Book Available on Lithium Treatment.......2007-07-03
This is an essential book for anyone considering lithium treatment for bipolar disorder (manic-depression) and also for anyone who is already taking lithium treatment. I used this book to decide whether to take lithium, and I have continued to refer to it over 23 years as questions have arisen during my lithium treatment. It has been invaluable. The book calls itself "A Practical Guide," and that is exactly what it is for the patient. It is clear, comprehensive, and accurate. It answers almost any question that one might have about treatment, side effects, risks, etc. The author is a well-known Danish psychiatrist who has had extensive experience with lithium treatment. He draws on research and on his own experience in answering questions about lithium treatment. He has a delightfully kind attitude toward patients, which makes reading the book a positive experience.
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Clinical Trial Registries: A Practical Guide for Sponsors and Researchers of Medicinal Products
Manufacturer: Birkhäuser Basel
ProductGroup: Book
Binding: Paperback
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ASIN: 3764375787 |
Book Description
Clinical Trial Registries: A Practical Guide for Sponsors and Researchers of Medicinal Products is a necessary addition to the library of all researchers who plan to publish their results in top-tier, peer-reviewed journals. ICMJE editors and other journal editors require registration of clinical trial information on publicly available Web sites before enrollment of study subjects and some countries and regions also require this information, as well as timely publication of study results. Not only does this book discuss the genesis of these requirements, it also provides practical information for researchers and sponsors on how to establish a workflow for a clinical registry project, how to file to a registry, and how to post results. More than 25 current Web addresses for registries are provided as well as a comprehensive annotated bibliography of papers on the topic of clinical trial registries. This book is a valuable source of information for all sponsors of medicinal products.
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Alcohol, Illicit Drugs and the Global Burden of Disease (European Addiction Research)
Rehm J. Zurich
Manufacturer: Not Avail
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ASIN: 3805572905 |
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Clin-Alert 2001: A Quick Reference to Adverse Clinical Events
Joyce Generali
Manufacturer: CRC
ProductGroup: Book
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ASIN: 1587160781 |
Book Description
Now the adverse drug reaction events reported in the newsletter Clin-Alert during Y2000 have been compiled, organized, re-formatted, indexed, and published in a convenient one-volume reference book, Clin-Alert 2001. The new book contains the full texts of all 311 reports from Clin-Alert newsletter 2000 issues. The reports have been grouped by fourteen major drug categories and indexed in six different ways for quick look-up. The reports were originally prepared for the Clin-Alert newsletter based on an ongoing search of more than 100 major medical journals, and summarization of key information included in journal articles on adverse drug reaction events. The summary reports were prepared by drug information specialists, and include the following information: o generic name of the drug or other substance involved o a brief characterization of the adverse reaction o a one paragraph summary of the event and related patient information o the author's conclusions or warnings o original source information Established in 1962, the Clin-Alert newsletter is a semi-monthly drug information service widely used by healthcare professionals involved in drug therapy and administration. It is independent, accepts no advertising, and is published for professional use. Now published, Clin-Alert 2001 provides an easy-to-use, quick and reliable reference that will be useful to healthcare professionals working with drugs.
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Drug Products for Clinical Trials: An Intl Guide to Formulation, Production, Quality Control (Drugs and the Pharmaceutical Sciences)
Manufacturer: Informa Healthcare
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Binding: Hardcover
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ASIN: 082479852X |
Book Description
This practical guide shows how the appropriate use of clinical materials can increase efficiency in bringing new products to the marketplace-offering authoritative assessments of the scientific and legal issues involved in the successful completion of clinical trials for marketing approval by regulatory agencies. The only wide-ranging, up-to-date book of its kind available on the subject! Describing both the science and management of product development, Drug Products for Clinical Trials · furnishes effective approaches for preclinical drug discovery · addresses the function of the clinical trials materials manager · covers the design of clinical protocols in developing a new chemical entity (NCE) · explains the importance of bioequivalence between clinical trials materials and final products · demonstrates rapid, reliable processes for clinical evaluation · discusses the interaction between clinical research, manufacturing, and packaging · reviews quality control strategies used in the manufacture of drug substances for clinical studies conducted throughout the world · and much more!
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Gamma Hydroxybutyrate - A Medical Dictionary, Bibliography, and Annotated Research Guide to Internet References
ICON Health Publications
Manufacturer: ICON Health Publications
ProductGroup: Book
Binding: Paperback
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ASIN: 0497004437 |
Book Description
This is a 3-in-1 reference book. It gives a complete medical dictionary covering hundreds of terms and expressions relating to gamma hydroxybutyrate. It also gives extensive lists of bibliographic citations. Finally, it provides information to users on how to update their knowledge using various Internet resources. The book is designed for physicians, medical students preparing for Board examinations, medical researchers, and patients who want to become familiar with research dedicated to gamma hydroxybutyrate. If your time is valuable, this book is for you. First, you will not waste time searching the Internet while missing a lot of relevant information. Second, the book also saves you time indexing and defining entries. Finally, you will not waste time and money printing hundreds of web pages.
Download Description
This is a 3-in-1 reference book. It gives a complete medical dictionary covering hundreds of terms and expressions relating to gamma hydroxybutyrate. It also gives extensive lists of bibliographic citations. Finally, it provides information to users on how to update their knowledge using various Internet resources. The book is designed for physicians, medical students preparing for Board examinations, medical researchers, and patients who want to become familiar with research dedicated to gamma hydroxybutyrate. If your time is valuable, this book is for you. First, you will not waste time searching the Internet while missing a lot of relevant information. Second, the book also saves you time indexing and defining entries. Finally, you will not waste time and money printing hundreds of web pages.
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Chemistry Experiments on File (Facts on File Science Library)
Diagram Group
Manufacturer: Facts on File
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Chemistry Experiments on File
Manufacturer: Facts on File
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ASIN: 0816044473 |
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Partial Differential Equations of First Order and Their Applications to Physics
Gustavo Lopez
Manufacturer: World Scientific Publishing Company
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ASIN: 9810237464 |
Book Description
This book is about the theory and applications of Partial Differential Equations of First Order (PDEFO). Many interesting topics in physics such as constant motion of dynamical systems, renormalization theory, Lagrange transformation, ray trajectories, and Hamilton-Jacobi theory are or can be formulated in terms of partial differential equations of first order. In this book, the author illustrates the utility of the powerful method of PDEFO in physics, and also shows how PDEFO are useful for solving practical problems in different branches of science. The book focuses mainly on the applications of PDEFO, and the mathematical formalism is treated carefully but without diverging from the main objective of the book.
Customer Reviews:
First Review.......2000-11-10
This is a poor text in partial differential equations. other cheaps are better than this book
Book Description
Heal Your Pain Now with Expressive Writing
What do diarists and journal writers know that can help anyone dealing with a traumatic or emotionally challenging situation recover from pain and regain their peace of mind?
They know that the act of putting thoughts and feelings on paper is, itself, a powerful exercise that makes them feel heard and acknowledged—a way of regaining perspective and control over the events that move through their lives.
In this book, the preeminent psychologist and researcher in the growing field of expressive emotions therapy, or EET, takes readers through a series of guided writing exercises that help them explore their feelings about difficult experiences. Each chapter begins with an introduction that explains how to proceed with the journal exercise and what it is structured to help accomplish. Readers are encouraged to do the exercise in the journal itself—each chapter provides plenty of ruled space—so that they can frequently refer to their own work and gain insight and clarity from their own words. The text offers encouragement and gentle advice for breaking through those inevitable moments when mental block make writing impossible; stream-of-consciousness and automatic writing clears away the obstacle and inspires the journal writer to even deeper levels of self-expression. The text stresses throughout the power for understanding and coping with difficult times that lies in storytelling, whether through fiction, dance, or art. In all, the exercises will leave readers with a strong sense of their value in the world and the ability to accept that which is sometimes hard to accept—that life can be good even when it is sometimes bad.
Customer Reviews:
Writing really does heal body and soul.......2007-09-07
I was excited when I first found out about Dr. Pennebaker's amazing research showing that writing helped to heal phsycial as well as emotional distress and illnesses. It was so exciting that I investigated the research, downloaded his articles, and decided to write a book that talked about this research and how writing can be used to heal in Becoming Whole: Writing Your Healing Story. The wonderful thing about this kind of writing is that it seems to work whether you believe in it or not. Therapists and healers from all over the world I hope will use these techniques to help heal many people who have found it hard to recover from trauma and emotional abuse.
I was very pleased when Dr. Pennebaker offered an endorsement for my book, and encouraged me to continue spreading the message about the healing power of writing. He is a kind man, inspiring, brilliant, and sincere. Kay Adams on her site for Journal Therapy has a terrific interview with Dr. Pennebaker that everyone should read.
a valuable addition to journaling books.......2007-03-31
I don't usually like books that tell you how to journal and then leave space to do so. However, as a psychotherapist, I admire the research of Pennebaker, and feel he provides validation for the healing power of journaling.
I would recommend this book and a few others, like Adams' "Journal to the Self" and the works of Capacchione to get yourself started on this process. Of course, there are probably a few hundred books on journaling that have been published in the last 30 years and it's always best to pick what works for you.
Writing to Heal.......2006-08-06
I found the exercises in this book easy to do. I also found it interesting that you were asked to limit the number of days you wrote. I guess I have a tendancy to want to dwell on things. Writing as I did, did seem to help me deal with the issue on which I focused. Pennebaker is a credible researcher and this approach is based on empirical study. I recommend it to others.
I couldn't agree more.......2006-03-05
This is a wonderful book for anyone who has experienced loss.
For some reason, the literary community is lagging this re emergence of narrative that is insightful, painful and ultimately healing. I applaude the author and the authors who have written books on personal travails that have changed their lives - Second Chance Ranch, A Year of Magical Thinking, to name only a few. I highly recommend it!
A Valuable Resource.......2004-04-13
Writing to Heal: A Guided Journal for Recovering from Trauma and Emotional Upheaval by James Pennebaker presents clear suggestions for using journaling to recover from life's difficult periods. Pennebaker, a researcher, discovered the healing power of expressive writing in the mid 1980s by accident. He writes in his introduction, "Ever since then, I've been devoted to understanding the mysteries of emotional writing." He's also been devoted to sharing what learned so that ordinary people can put this knowledge to good use.
Writing to Heal is an excellent resource for anyone who wants to try writing through trauma. In addition to expressive writing, Pennebaker covers how to construct story in order to understand and overcome a traumatic event. Other topics include looking for and writing about positive emotions, finding benefit from the experience, and forgiveness. Of special note are his instructions about using pronouns to shift perspective, a technique that arose from his research.
In my own work with bereaved people, I've repeatedly seen the mysterious power of writing to heal. Pennebaker's guided journal stands out because in it he shares technique without providing specific prompts that too often distract people from reaching inside to deal with their unique emotional issues.
I also like the fact that the book is written in a simple style. Pennebaker's concise, no-nonsense writing means that this book is useful to a number of people, including those who normally don't read many books and those who are too emotionally distraught to concentrate on a longer book. I will definitely recommend Writing to Heal in my workshops and when I speak at conferences.
Book Description
Learn to create a positive research/action alliance similar to that of DePaul University and the Oxford House community
This book reviews important research conducted in a 13-year collaborative partnership between Oxford House (a community-based, self-run residential substance abuse recovery program) and DePaul University. It also presents practical guidelines for developing effective action research collaborative programs that can cultivate and maintain mutually beneficial community/research partnerships.
Creating Communities for Addiction Recovery: The Oxford House Model presents and examines:
practical guidelines for developing effective action research collaboratives focusing on the development of trust, respecting the personal experiences of the community members and the group, commitment to serving the community, validating findings with organization members, and accountability
the experiences and attitudes of Oxford House community members in light of their participation in the collaborative research projects described in the book
the essentials of designing and creating an efficient and productive yet homey residential community environment for addicted persons
the factors that make Oxford Houses in the United States and Australia "safe and sober" settings for persons in recovery
the differential growth among self-governed substance abuse recovery homes for men and for women—with a focus on the impact of state loan programs and the utilization of technical assistance in relation to the expansion of women's houses as compared with men's
the economic advantages of the Oxford House model as compared with other treatment and incarceration alternatives
the roles of ethnicity and gender in substance abuse recovery
the structural social support of Oxford House men—and the impact of parenthood on these men's substance use patterns and recovery attempts
the medical care (need and utilization) patterns of a substance abusing and recovering population
how Oxford House's African-American community functions as a source of abstinent social networks
the sense of community among women and women with children living in Oxford Houses—with emphasis on how the presence of children impacts the household
perspectives of leadership by women (some with children, some without) affiliated with Oxford Houses The information in this book shows that the rules of the game have changed. Substance abusers now can take charge of their own recovery in effective and efficient ways, and practitioners can find low-cost housing options for their clients with substance abuse problems. As a part of your professional/teaching collection, Creating Communities for Addiction Recovery can help you or your students take understand and make effective use of this rapidly evolving paradigm of community-based recovery.
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- You Just Can't Go Wrong with Sarton
|
Recovering: A Journal
May Sarton
Manufacturer: W. W. Norton & Company
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Binding: Paperback
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After the Stroke: A Journal
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Journal of a Solitude
ASIN: 039331717X |
Book Description
May Sarton's sixty-sixth year,1978-79, was a difficult time: a cherished relationship came to an end, she had a mastectomy, she fought against depression. How her friendships, her love of the natural world, and her growing audience of readers brought her back is this journal's story.
Customer Reviews:
You Just Can't Go Wrong with Sarton.......2007-05-30
Reading Sarton is like taking in fresh air! "Recovering" is no exception. Sarton is always an easy read, but you have to be prepared to "FEEL" - she is so open with her emotions and experiences. Sarton cuts right to the core of human experience and emotion in a simple, straight forward way. Although she expresses her grief and losses in a poignent and potent manner, she is not sentimental and "Recovering", like her other works, leaves one with a certian calmness even amid all of the emotional turbulance.
"Recovering" also is typically "Sartonian" in that her eye for the beautiful simplicity in nature and the in small details is ever present in this journal.
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Best Regards: Recovering the Art of Soulful Letter Writing
Ben Alex
Manufacturer: Scandinavia
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Binding: Hardcover
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Inspirational
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ASIN: 8772474971 |
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Recovering Literature's Lost Ground: Essays in American Autobiography
James M. Cox
Manufacturer: Louisiana State University Press
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ASIN: 080711491X |
Book Description
This digital document is an article from Journal of Educational Multimedia and Hypermedia, published by Thomson Gale on September 22, 2005. The length of the article is 5482 words. The page length shown above is based on a typical 300-word page. The article is delivered in HTML format and is available in your Amazon.com Digital Locker immediately after purchase. You can view it with any web browser.
Citation Details
Title: Adventures in evaluation: reviewing a CD-ROM based adventure game designed for young people recovering from psychosis.
Author: Bradley Shrimpton
Publication:
Journal of Educational Multimedia and Hypermedia (Magazine/Journal)
Date: September 22, 2005
Publisher: Thomson Gale
Volume: 14
Issue: 3
Page: 273(18)
Distributed by Thomson Gale
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