Conducting Gcp Compliant Clinical Research
DOWNLOAD
Download Conducting Gcp Compliant Clinical Research PDF/ePub or read online books in Mobi eBooks. Click Download or Read Online button to get Conducting Gcp Compliant Clinical Research book now. This website allows unlimited access to, at the time of writing, more than 1.5 million titles, including hundreds of thousands of titles in various foreign languages. If the content not found or just blank you must refresh this page
Conducting Gcp Compliant Clinical Research
DOWNLOAD
Author : Wendy Bohaychuk
language : en
Publisher: John Wiley & Sons
Release Date : 1999-06-02
Conducting Gcp Compliant Clinical Research written by Wendy Bohaychuk and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 1999-06-02 with Medical categories.
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.
Conducting Gcp Compliant Clinical Research
DOWNLOAD
Author : Wendy Bohaychuk
language : en
Publisher: John Wiley & Sons
Release Date : 1999-06-02
Conducting Gcp Compliant Clinical Research written by Wendy Bohaychuk and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 1999-06-02 with Medical categories.
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.
Principles And Practice Of Pharmaceutical Medicine
DOWNLOAD
Author : Andrew J. Fletcher
language : en
Publisher: John Wiley & Sons
Release Date : 2003-01-31
Principles And Practice Of Pharmaceutical Medicine written by Andrew J. Fletcher and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003-01-31 with Medical categories.
Principles and Practice of Pharmaceutical Medicine begins with a detailed overview of its origins, and goes on to examine current career opportunities, education and training. Encompassing the entire spectrum of pharmaceutical medicine, it also discusses international drug development and registration, including animal toxicology and human volunteers, pharmacoeconomics and statistics, medical services, legal and ethical issues and business aspects. It is the most up-to-date guide to drug development and marketing, and the only book with an international outlook. * The authors are all experts in their field and include an assessment of the current status of their specialities * This book provides an insight into how things may develop in the future * It is designed to be a guide for those who are actually practicing pharmaceutical medicine
Good Practice Of Clinical Drug Trials
DOWNLOAD
Author : Alain Spriet
language : en
Publisher: LIBRAIRIE LUGINBUHL
Release Date : 2005
Good Practice Of Clinical Drug Trials written by Alain Spriet and has been published by LIBRAIRIE LUGINBUHL this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005 with Medical categories.
This new edition of `Good Practice' is a totally revised and expanded version of this work. It takes into account the new quality guidelines, in particular those listed in the European Union Directive, the application texts and the recommendations of the International Conference on Harmonisation (ICH). It is a practical manual to help you conduct your clinical trials. Many new or revised concepts have been included, in particular: - Rationale for each rule presented - Safety of data in clinical trials - Protection of personal data - Conflicts of interest - Measures to be taken in case of suspected fraud
Principles And Practice Of Pharmaceutical Medicine
DOWNLOAD
Author : Lionel D. Edwards
language : en
Publisher: John Wiley & Sons
Release Date : 2011-07-12
Principles And Practice Of Pharmaceutical Medicine written by Lionel D. Edwards and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-07-12 with Medical categories.
The new edition of Principles and Practice of Pharmaceutical Medicine is a comprehensive reference guide to all aspects of pharmaceutical medicine. New content includes chapters and coverage on regulatory updates, increasing international harmonization, transitional and probabilistic approaches to drug development, the growing sophistication and regulatory importance of pharmacovigilance, personalized medicine and growth in biotechnology as a source of new experimental drugs.
Encyclopedia Of Health Care Management
DOWNLOAD
Author : Michael J. Stahl
language : en
Publisher: SAGE Publications
Release Date : 2003-10-21
Encyclopedia Of Health Care Management written by Michael J. Stahl and has been published by SAGE Publications this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003-10-21 with Medical categories.
"The most comprehensive one-volume reference work on health care management published in the last 10 years, this work brings together much useful information and will appeal to a broad audience. Health science libraries, college libraries, and large public libraries will want to invest in this title." --BOOKLIST "This volume should be considered by academic and public libraries with large healthcare management or business collections as the only current reference on this topic." --LIBRARY JOURNAL "The Encyclopedia of Health Care Management would be useful for those involved in any aspect of health care, whether as a student, instructor, practitioner, researcher, or administrator. This book would be of great use in reference collections at public, university, hospital, and corporate libraries." --E-STREAMS Health care is one of today′s most discussed and debated topics. From issues such as accessibility to costs to quality, the debates range widely among doctors, patients, employers, and insurers. A popular topic in political campaigns and the media, health care and health care management is also a quiet and unremitting concern in the private and personal lives of individuals who worry about someday having to choose between food and prescription drugs. For this reason, in today′s health care industry, good business practices may be as important as the practice of medicine in assuring the continued health of the industry. The Encyclopedia of Health Care Management will prove invaluable to libraries serving students and professionals in health and business. It will also be an essential reference for physicians, providers and their employees, and students and professors in health and management for responsible and successful practice and administration in the health care industry. This encyclopedia is the most comprehensive reference work on the business of health care, with up-to-date information across a broad range of issues affecting every aspect of the industry and the people it serves, employs, and influences. Key Features The most comprehensive reference work on health care management Broad range of timely topics, spanning academic, corporate and governmental arenas Over 600 entries More than 160 expert contributors in the fields of medicine, public health, and business Tables on Health Care Acronyms Medical Degrees Medical Legislation Medical Organizations Medical Specialties About the Editor Michael J. Stahl, Ph.D. is Director of the Physician Executive MBA Program and Distinguished Professor of Management in the College of Business at the University of Tennessee, Knoxville. Dr. Stahl received his B.S. in Electrical Engineering from the State University of NY at Buffalo and his Ph.D. in Management from Rensselaer Polytechnic Institute. From 1982-1989, Stahl was Head of the Management Department at Clemson University He was Associate Dean in the College of Business at the University of Tennessee from 1989-1997. Dr. Stahl has published over 50 journal articles in a variety of areas including Strategic Management, TQ, and healthcare, as well as twelve books including Strategic Management, Perspectives in TQ, and The Physician′s Essential MBA. He teaches strategy and business planning in the Physician EMBA, Taiwan EMBA, and MBA Programs. Recommended Libraries Academic, Public, Special, Private/Corporate
Manufacturing Of Pharmaceutical Proteins
DOWNLOAD
Author : Stefan Behme
language : en
Publisher: John Wiley & Sons
Release Date : 2015-02-13
Manufacturing Of Pharmaceutical Proteins written by Stefan Behme and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-02-13 with Science categories.
Structured like a textbook, the second edition of this reference covers all aspects of biopharmaceutical manufacturing, including legal and regulatory issues, production facility design, and quality assurance, with a focus on supply chain management and regulations in emerging markets and cost control. The author has longstanding industrial expertise in biopharmaceutical production and years of experience teaching at universities. As such, this practical book is ideal for use in academia as well as for internal training within companies.
The Bloomsbury Handbook Of Posthumanism
DOWNLOAD
Author : Mads Rosendahl Thomsen
language : en
Publisher: Bloomsbury Publishing
Release Date : 2020-07-23
The Bloomsbury Handbook Of Posthumanism written by Mads Rosendahl Thomsen and has been published by Bloomsbury Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-07-23 with Literary Criticism categories.
As our ideas of the human have come under increasing challenges – from technological change, from medical advances, from the existential threat of climate crisis, from an ideological decentering of the human, amongst many other things – the 'posthuman' has become an increasingly central topic in the Humanities. Bringing together leading scholars from across the world and a wide range of disciplines, this is the most comprehensive available survey of cutting edge contemporary scholarship on posthumanism in literature, culture and theory. The Bloomsbury Handbook of Posthumanism explores: - Central critical concepts and approaches, including transhumanism, new materialism and the Anthropocene - Ethical perspectives on ecology, race, gender and disability - Technology, from data and artificial intelligence to medicine and genetics - A wide range of genres and forms, from literary and science fiction, through film, television and music, to comics, video games and social media.
Stephens Detection Of New Adverse Drug Reactions
DOWNLOAD
Author : John Talbot
language : en
Publisher: John Wiley & Sons
Release Date : 2004-11-19
Stephens Detection Of New Adverse Drug Reactions written by John Talbot and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004-11-19 with Medical categories.
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
Principles And Practice Of Clinical Trial Medicine
DOWNLOAD
Author : Richard Chin
language : en
Publisher: Elsevier
Release Date : 2008-07-25
Principles And Practice Of Clinical Trial Medicine written by Richard Chin and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-07-25 with Medical categories.
Clinical trials are an important part of medicine and healthcare today, deciding which treatments we use to treat patients. Anyone involved in healthcare today must know the basics of running and interpreting clinical trial data. Written in an easy-to-understand style by authors who have considerable expertise and experience in both academia and industry, Principles and Practice of Clinical Trial Medicine covers all of the basics of clinical trials, from legal and ethical issues to statistics, to patient recruitment and reporting results. - Jargon-free writing style enables those with less experience to run their own clinical trials and interpret data - Book contains an ideal mix of theory and practice so researchers will understand both the rationale and logistics to clinical trial medicine - Expert authorship whose experience includes running clinical trials in an academic as well as industry settings - Numerous illustrations reinforce and elucidate key concepts and add to the book's overall pedagogy