Author : Cohen
Publisher : Unknown
Page : 222 pages
File Size : 51,7 Mb
Release : 2009-08-01
Category : Electronic
ISBN : 8184893108
A Guide To Clinical Drug Research, 2E
Cohen
A Guide To Clinical Drug Research 2e
A Guide To Clinical Drug Research 2e Book in PDF, ePub and Kindle version is available to download in english. Read online anytime anywhere directly from your device. Click on the download button below to get a free pdf file of A Guide To Clinical Drug Research 2e book. This book definitely worth reading, it is an incredibly well-written.
A Guide to Clinical Drug Research
A. Cohen,J. Posner
Author : A. Cohen,J. Posner
Publisher : Springer Science & Business Media
Page : 205 pages
File Size : 48,7 Mb
Release : 2013-04-17
Category : Medical
ISBN : 9789401584630
A Guide to Clinical Drug Research by A. Cohen,J. Posner Pdf
A Guide to Clinical Drug Research provides practical advice, from the conception of an idea, planning a study and writing a protocol, through to the conduct of a study, data collection and analysis, and publication. It tells investigators what information they should expect sponsoring companies to provide, particularly when there is only limited information available about a new drug. It also explains what the company can expect of investigators, including the requirements of `good clinical practice'. Unlike other currently available texts on clinical trials and pharmaceutical medicine, A Guide to Clinical Drug Research concentrates on the needs of the practising clinician and research team. It is not restricted to drug investigation, and is relevant to all those involved in clinical research in a variety of settings. Audience: Required reading for clinical researchers and others involved as investigators in a drug project, often sponsored by a pharmaceutical company, plus agents of the sponsoring companies themselves.
Clinical Trials
Tom Brody
Author : Tom Brody
Publisher : Academic Press
Page : 897 pages
File Size : 46,7 Mb
Release : 2016-02-19
Category : Medical
ISBN : 9780128042588
Clinical Trials by Tom Brody Pdf
Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials. Contains new and fully revised material on key topics such as biostatistics, biomarkers, orphan drugs, biosimilars, drug regulations in Europe, drug safety, regulatory approval and more Extensively covers the "study schema" and related features of study design Incorporates laboratory data from studies on human patients to provide a concrete tool for understanding the concepts in the design and conduct of clinical trials Includes decisions made by FDA reviewers when granting approval of a drug as real world learning examples for readers
Handbook of Phase I/II Clinical Drug Trials
John O'Grady,Pieter H. Joubert
Author : John O'Grady,Pieter H. Joubert
Publisher : CRC-Press
Page : 576 pages
File Size : 54,5 Mb
Release : 1997-01-14
Category : Medical
ISBN : 0849392306
Handbook of Phase I/II Clinical Drug Trials by John O'Grady,Pieter H. Joubert Pdf
Phase I/II Clinical Drug Trials is a quick, easy-to-use source of data, an indispensable guide, readily providing the information needed to make crucial decisions regarding drug therapies. This book makes it easy to plan cost-effective, early drug development programs. The first four sections of the text deal with the preliminaries to studying drugs in humans, as well as considerations common to early drug trials in human subjects. Part II considers organization and decision making factors. Ethical and legal considerations are discussed in the next section. Subsequent chapters deal with specific therapeutic areas and indications. Areas of growing importance, such as studying in vitro metabolism in human hepatocytes and genetic engineering are highlighted as well.
A Practical Guide to Managing Clinical Trials
JoAnn Pfeiffer,Cris Wells
Author : JoAnn Pfeiffer,Cris Wells
Publisher : CRC Press
Page : 292 pages
File Size : 44,6 Mb
Release : 2017-05-18
Category : Mathematics
ISBN : 9781315299778
A Practical Guide to Managing Clinical Trials by JoAnn Pfeiffer,Cris Wells Pdf
A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application. Unique to this book is "A View from India," a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials.
A Concise Guide to Clinical Trials
J. Rick Turner
Author : J. Rick Turner
Publisher : Unknown
Page : 114 pages
File Size : 53,9 Mb
Release : 2011-09-01
Category : Clinical trials
ISBN : 0615507670
A Concise Guide to Clinical Trials by J. Rick Turner Pdf
Biopharmaceutical drugs improve the health and well-being of people across the globe on a scale that is unrivaled by any other medical intervention. Before these drugs can be prescribed for patients by their doctors, they have to be approved for marketing by a regulatory agency. To gain marketing approval, drugs must go through an extremely rigorous process that investigates their safety and efficacy, the process of New Drug Development. The last stage of this long, complex, and expensive process involves conducting clinical trials, the topic of this book. Successfully conducting clinical trials requires the interdisciplinary collaboration of individuals from many clinical and scientific disciplines and areas of operational expertise. These include medicine, information technology, ethics and law, statistics, clinical trial operations, data collection and management, regulatory science, and medical writing, to name just a few. Central aspects of conducting clinical trials are discussed in the following chapters, with the goals of making specialists from each of these areas aware of the contributions of their colleagues, and helping readers to appreciate that everyone involved in clinical research is working side-by-side toward a common goal---improving the health, well-being, and longevity of millions of patients around the globe.
A Quick Guide to Clinical Trials
Madhu Davies,Faiz Kermani
Author : Madhu Davies,Faiz Kermani
Publisher : Ingram
Page : 0 pages
File Size : 52,8 Mb
Release : 2008
Category : Clinical trials
ISBN : 1934106089
A Quick Guide to Clinical Trials by Madhu Davies,Faiz Kermani Pdf
Global Clinical Trials
Richard Chin,Menghis Bairu
Author : Richard Chin,Menghis Bairu
Publisher : Academic Press
Page : 522 pages
File Size : 52,8 Mb
Release : 2011-05-06
Category : Science
ISBN : 012381538X
Global Clinical Trials by Richard Chin,Menghis Bairu Pdf
This book will explore the great opportunities and challenges which exist in conducting clinical trials in developing countries. By exploring the various regulations specific to the major players and providing insight into the logistical challenges including language barriers, this book provides a working tool for clinical researchers and administrators to navigate the intricacies of clinical trials in developing countries. Important topics such as ethical issues will be handled very carefully to highlight the significant differences of conducting this work in various jurisdictions. Overall, it will present a clear and comprehensive guide to the ins-and-outs of clinical trials in various countries to assist in design, development, and effectiveness of these trials. Contributors include high-profile, respected figures who have paved the way for clinical trials in developing countries Provides hands-on tools for regulatory and legal requirements and qualification, design, management, and reporting Case studies outline successes, failures, lessons learned and prospects for future collaboration Includes country-specific guidelines for the most utilized countries Foreword by David Feigel, former Head of CDRH at FDA
Key Statistical Concepts in Clinical Trials for Pharma
J. Rick Turner
Author : J. Rick Turner
Publisher : Springer Science & Business Media
Page : 66 pages
File Size : 42,9 Mb
Release : 2011-10-14
Category : Medical
ISBN : 9781461416623
Key Statistical Concepts in Clinical Trials for Pharma by J. Rick Turner Pdf
This Brief discusses key statistical concepts that facilitate the inferential analysis of data collected from a group of individuals participating in a pharmaceutical clinical trial, the estimation of their clinical significance in the general population of individuals likely to be prescribed the drug if approved, and the related decision-making that occurs at both the public health level (by regulatory agencies when deciding whether or not to approve a new drug for marketing) and the individual patient level (by physicians and their patients when deciding whether or not the patient should be prescribed a drug that is on the market). These concepts include drug safety and efficacy, statistical significance, clinical significance, and benefit-risk balance.
A Practical Guide to Human Research and Clinical Trials
M. U. R. Naidu,P. Usha Rani
Author : M. U. R. Naidu,P. Usha Rani
Publisher : CRC Press
Page : 350 pages
File Size : 52,8 Mb
Release : 2013-01-29
Category : Medical
ISBN : 146659117X
A Practical Guide to Human Research and Clinical Trials by M. U. R. Naidu,P. Usha Rani Pdf
Regulatory bodies such as the European Medicine Agency have done tremendous work in collaboration with experts from the field to develop Good Clinical Practices that apply not only in Europe but also in emerging countries. Designed to be a teaching aid and reference guide, A Practical Guide to Human Research and Clinical focuses on ethics, regulations, and guidelines. Conducting a successful clinical trial requires not only a strong basic knowledge, but also hands-on practical training. The book explains the intricate details of the subject to readers by citing concrete cases, exercises, and templates along with the theoretical aspects. Prof. M.U.R Naidu and his co-authors address all aspects of clinical trials from clinical research, drug development, and quality to methodology, biostatistics, and pharmacovigilance.
Understanding Clinical Research
Renato D. Lopes,Robert A. Harrington
Author : Renato D. Lopes,Robert A. Harrington
Publisher : McGraw Hill Professional
Page : 262 pages
File Size : 42,5 Mb
Release : 2013-05-22
Category : Medical
ISBN : 9780071792653
Understanding Clinical Research by Renato D. Lopes,Robert A. Harrington Pdf
A complete guide to understanding and applying clinical research results Ideal for both researchers and healthcare providers Understanding Clinical Research addresses both the operational challenges of clinical trials and the needs of clinicians to comprehend the nuances of research methods to accurately analyze study results. This timely resource covers all aspects of clinical trials--from study design and statistics to regulatory oversight--and it delivers a detailed yet streamlined overview of must-know research topics. The text features an accessible three-part organization that traces the evolution of clinical research and explains the bedrock principles and unique challenges of clinical experimentation and observational research. Reinforcing this content are real-life case examples--drawn from the authors' broad experience--that put chapter concepts into action and contribute to a working knowledge of integral research techniques. FEATURES: The most definitive guide to promoting excellence in clinical research, designed to empower healthcare providers to assess a study's strengths and weaknesses with confidence and apply this knowledge to optimize patient outcomes In-depth coverage of fundamental research methods and protocols from preeminent authorities provides readers with an instructive primer and a springboard for ongoing clinical research education Clear, comprehensive three-part organization: Section One: Evolution of Clinical Research offers a succinct history of clinical trials, drug regulations, and the role of the FDA while covering the impact of information technology and academic research organizations Section Two: Principles of Clinical Experimentation takes you through the typical phases of clinical trials in the development of medical products, from initial human subject research to postapproval surveillance studies Section Three: Observational Research highlights the underlying principles, pitfalls, and methods for case-control studies, cohort studies, registries, and subgroup analyses within randomized trials
Clinical Trials Handbook
Shayne Cox Gad
Author : Shayne Cox Gad
Publisher : John Wiley & Sons
Page : 1247 pages
File Size : 52,9 Mb
Release : 2009-06-17
Category : Science
ISBN : 9780470466353
Clinical Trials Handbook by Shayne Cox Gad Pdf
Best practices for conducting effective and safe clinical trials Clinical trials are arguably the most important steps in proving drug effectiveness and safety for public use. They require intensive planning and organization and involve a wide range of disciplines: data management, biostatistics, pharmacology, toxicology, modeling and simulation, regulatory monitoring, ethics, and particular issues for given disease areas. Clinical Trials Handbook provides a comprehensive and thorough reference on the basics and practices of clinical trials. With contributions from a range of international authors, the book takes the reader through each trial phase, technique, and issue. Chapters cover every key aspect of preparing and conducting clinical trials, including: Interdisciplinary topics that have to be coordinated for a successful clinical trialData management (and adverse event reporting systems) Biostatistics, pharmacology, and toxicology Modeling and simulation Regulatory monitoring and ethics Particular issues for given disease areas-cardiology, oncology, cognitive, dementia, dermatology, neuroscience, and more With unique information on such current issues as adverse event reporting (AER) systems, adaptive trial designs, and crossover trial designs, Clinical Trials Handbook will be a ready reference for pharmaceutical scientists, statisticians, researchers, and the many other professionals involved in drug development.
A Comprehensive Guide to Toxicology in Nonclinical Drug Development
Ali S. Faqi
Author : Ali S. Faqi
Publisher : Elsevier
Page : 1074 pages
File Size : 49,6 Mb
Release : 2024-02-11
Category : Medical
ISBN : 9780323984621
A Comprehensive Guide to Toxicology in Nonclinical Drug Development by Ali S. Faqi Pdf
A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Third Edition is a valuable reference providing a complete understanding of all aspects of nonclinical toxicology in pharmaceutical research. This updated edition has been expanded and re-developed covering a wide-range of toxicological issues in small molecules and biologics. Topics include ADME in drug discovery, pharmacokinetics, toxicokinetics, formulations, and genetic toxicology testing. The book has been thoroughly updated throughout to reflect the latest scientific advances and includes new information on antiviral drugs, anti-diabetic drugs, immunotherapy, and a discussion on post-pandemic drug development challenges and opportunities. This is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic, and regulatory settings. Provides updated, unique content not covered in one comprehensive resource, including chapters on stem cells, antiviral drugs, anti-diabetic drugs, and immunotherapy Includes the latest international guidelines for nonclinical toxicology in both small and large molecules Incorporates practical examples in order to illustrate day-to-day activities and expectations associated with working in nonclinical toxicology
Handbook of Clinical Research
Julia Lloyd,Ann Raven,Association for Clinical Research in the Pharmaceutical Industry
Author : Julia Lloyd,Ann Raven,Association for Clinical Research in the Pharmaceutical Industry
Publisher : Unknown
Page : 491 pages
File Size : 41,7 Mb
Release : 1994
Category : Clinical trials
ISBN : 044305004X
Handbook of Clinical Research by Julia Lloyd,Ann Raven,Association for Clinical Research in the Pharmaceutical Industry Pdf
A comprehensive and practical guide covering the multidisciplinary aspects of clinical drug research. There are multi-author contributions from both scientists and clinicians from pharmaceutical and medical professions, giving practical information and informed comment on benefits and pitfalls.
New Drug Development
J. Rick Turner
Author : J. Rick Turner
Publisher : Unknown
Page : 256 pages
File Size : 47,5 Mb
Release : 2010
Category : Drug development
ISBN : 1493991922
New Drug Development by J. Rick Turner Pdf
New Drug Development, 2nd Edition, is a reader-friendly introduction to clinical trials that is written specifically for entry-level professionals in the pharmaceutical, biopharmaceutical, and contract research organization (CRO) industries. It is also excellent reading for seasoned clinical research professionals who wish to refresh their knowledge in areas outside their immediate fields of expertise, and for students of clinical research, pharmacy, medicine, nursing, and allied health professions. While the main focus is on preapproval clinical trials, the book adopts a lifecycle drug development approach, placing these trials in the overall continuum from drug discovery to postmarketing surveillance. It therefore contains brief discussions of medicinal chemistry, nonclinical research, drug manufacturing, and the latest techniques for gathering information concerning adverse drug reactions. This edition builds on the success of the first edition by keeping the discussions that were most helpful to readers, and adding new chapters addressing important contemporary topics in drug development. The chapters dealing with the design and analysis of clinical trials in the first edition received praise from many sources. This new edition incorporates extended discussions of the operational aspects of conducting various kinds of trials, ranging from highly specialized and relatively small cardiac safety studies to very large, multi-site Phase III trials run in several different countries.