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Author : University of Michigan. School of Dentistry
Publisher :
ISBN 13 :
Total Pages : 104 pages
Book Rating : 4.3/5 (91 download)
Download or read book Clinical Preclinical Procedure Manual written by University of Michigan. School of Dentistry and published by . This book was released on 1990 with total page 104 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Carol Hollingsworth
Publisher :
ISBN 13 : 9780683142099
Total Pages : 372 pages
Book Rating : 4.1/5 (42 download)
Download or read book Clinical Procedure Manual for Home Healthcare written by Carol Hollingsworth and published by . This book was released on 1992-05 with total page 372 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : University of Michigan. School of Dentistry
Publisher :
ISBN 13 :
Total Pages : 94 pages
Book Rating : 4.3/5 (91 download)
Download or read book Pre-clinical Clinical Procedure Manual, University of Michigan School of Dentistry written by University of Michigan. School of Dentistry and published by . This book was released on 1987 with total page 94 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Beverly A. Teicher
Publisher : Springer Science & Business Media
ISBN 13 : 1461581524
Total Pages : 315 pages
Book Rating : 4.4/5 (615 download)
Download or read book Anticancer Drug Development Guide written by Beverly A. Teicher and published by Springer Science & Business Media. This book was released on 2013-11-11 with total page 315 pages. Available in PDF, EPUB and Kindle. Book excerpt: Experienced cancer researchers from pharmaceutical companies, government laboratories, and academia comprehensively review and describe the arduous process of cancer drug discovery and approval. They focus on using preclinical in vivo and in vitro methods to identify molecules of interest, detailing the targets and criteria for success in each type of testing and defining the value of the information obtained from the various tests. They also define each stage of clinical testing, explain the criteria for success, and outline the requirements for FDA approval. A companion volume by the same editor (Cancer Therapeutics: Experimental and Clinical Agents) reviews existing anticancer drugs and potential anticancer therapies. These two volumes in the Cancer Drug Discovery and Development series reveal how and why molecules become anticancer drugs and thus offer a blueprint for the present and the future of the field.
Author : University of Michigan. School of Dentistry
Publisher :
ISBN 13 :
Total Pages : 96 pages
Book Rating : 4.3/5 (91 download)
Download or read book Pre-clinical Clinical Procedure Manual written by University of Michigan. School of Dentistry and published by . This book was released on 1986 with total page 96 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : JoAnn Pfeiffer
Publisher : CRC Press
ISBN 13 : 1315299771
Total Pages : 292 pages
Book Rating : 4.3/5 (152 download)
Download or read book A Practical Guide to Managing Clinical Trials written by JoAnn Pfeiffer and published by CRC Press. This book was released on 2017-05-18 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Author : Shayne Cox Gad
Publisher : John Wiley & Sons
ISBN 13 : 0470248475
Total Pages : 1346 pages
Book Rating : 4.4/5 (72 download)
Download or read book Preclinical Development Handbook written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2008-03-14 with total page 1346 pages. Available in PDF, EPUB and Kindle. Book excerpt: A clear, straightforward resource to guide you through preclinical drug development Following this book's step-by-step guidance, you can successfully initiate and complete critical phases of preclinical drug development. The book serves as a basic, comprehensive reference to prioritizing and optimizing leads, dose formulation, ADME, pharmacokinetics, modeling, and regulations. This authoritative, easy-to-use resource covers all the issues that need to be considered and provides detailed instructions for current methods and techniques. Each chapter is written by one or more leading experts in the field. These authors, representing the many disciplines involved in preclinical toxicology screening and testing, give you the tools needed to apply an effective multidisciplinary approach. The editor has carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear. Among the key topics covered are: * Modeling and informatics in drug design * Bioanalytical chemistry * Absorption of drugs after oral administration * Transporter interactions in the ADME pathway of drugs * Metabolism kinetics * Mechanisms and consequences of drug-drug interactions Each chapter offers a full exploration of problems that may be encountered and their solutions. The authors also set forth the limitations of various methods and techniques used in determining the safety and efficacy of a drug during the preclinical stage. This publication should be readily accessible to all pharmaceutical scientists involved in preclinical testing, enabling them to perform and document preclinical safety tests to meet all FDA requirements before clinical trials may begin.
Author : Guy Healing
Publisher : CRC Press
ISBN 13 : 9780748408672
Total Pages : 344 pages
Book Rating : 4.4/5 (86 download)
Download or read book Handbook of Pre-Clinical Continuous Intravenous Infusion written by Guy Healing and published by CRC Press. This book was released on 2000-08-31 with total page 344 pages. Available in PDF, EPUB and Kindle. Book excerpt: Any scientist or technician involved in pre-clinical drug studies knows that infusing animal models with test substances is no simple matter, especially if one wants to do it humanely as well as guarantee results that are not compromised by the procedure. The challenge becomes compounded if one is employing a variety of species. What works for a rat or mouse does not necessarily work for a rabbit or primate. The Handbook of Pre-clinical Continuous Intravenous Infusion answers the needs of researchers and technicians by providing complete instructions for a wide range of infusion techniques delivered to several species. With sections devoted to rats, mice, rabbits, dogs, mini-pigs, and nonhuman primates (both large and small), this thorough text gives step-by-step instructions for the use of a variety of techniques, and equipment. It includes procedures for multidose infusion toxicity and reproductive toxicology studies, and provides guidance on the use of a variety of equipment, including tail cuffs, harnesses, and implanted buttons. It also offers detailed information on surgical preparation for primates and mini-pigs, along with advice about the use of preoperative anesthesia, post surgical analgesics, and antibiotic administration, as well as valuable input on surgical suite design. "... I was amazed and gratified about the level of detail and the practical emphasis on technical expertise and animal well-being. This book is unique in having that as an overt aim." From the Foreword, David B. Morton, University of Birmingham, UK The text concludes with a chapter on general non-species-specific information that discusses common pathological findings in continuous infusion studies, the use of mini-osmatic pumps, and controllable variables such as vehicles, rates of administration and volumes. With contributions from several established experts in the handling of pre-clinical animal models, this authoritative volume removes the need for any guesswork, allowing technicians and researchers to proceed with confidence in undertaking critical studies.
Author : Margaret Liu
Publisher : Wiley-Blackwell
ISBN 13 : 9781405195157
Total Pages : 424 pages
Book Rating : 4.1/5 (951 download)
Download or read book A Clinical Trials Manual From The Duke Clinical Research Institute written by Margaret Liu and published by Wiley-Blackwell. This book was released on 2010-02-08 with total page 424 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The publication of the second edition of this manual comes at an important juncture in the history of clinical research. As advances in information technology make it possible to link individuals and groups in diverse locations in jointly seeking the answers to pressing global health problems, it is critically important to remain vigilant about moral and ethical safeguards for every patient enrolled in a trial. Those who study this manual will be well aware of how to ensure patient safety along with fiscal responsibility, trial efficiency, and research integrity." —Robert Harrington, Professor of Medicine, Director, Duke Clinical Research Institute, Durham, North Carolina, USA The Duke Clinical Research Institute (DCRI) is one of the world's leading academic clinical research organizations; its mission is to develop and share knowledge that improves the care of patients around the world through innovative clinical research. This concise handbook provides a practical "nuts and bolts" approach to the process of conducting clinical trials, identifying methods and techniques that can be replicated at other institutions and medical practices. Designed for investigators, research coordinators, CRO personnel, students, and others who have a desire to learn about clinical trials, this manual begins with an overview of the historical framework of clinical research, and leads the reader through a discussion of safety concerns and resulting regulations. Topics include Good Clinical Practice, informed consent, management of subject safety and data, as well as monitoring and reporting adverse events. Updated to reflect recent regulatory and clinical developments, the manual reviews the conduct of clinical trials research in an increasingly global context. This new edition has been further expanded to include: In-depth information on conducting clinical trials of medical devices and biologics The role and responsibilities of Institutional Review Boards, and Recent developments regarding subject privacy concerns and regulations. Ethical documents such as the Belmont Report and the Declaration of Helsinki are reviewed in relation to all aspects of clinical research, with a discussion of how researchers should apply the principles outlined in these important documents. This graphically appealing and eminently readable manual also provides sample forms and worksheets to facilitate data management and regulatory record retention; these can be modified and adapted for use at investigative sites.
Author : Sumantra Ray
Publisher : Oxford University Press
ISBN 13 : 0199608474
Total Pages : 603 pages
Book Rating : 4.1/5 (996 download)
Download or read book Oxford Handbook of Clinical and Healthcare Research written by Sumantra Ray and published by Oxford University Press. This book was released on 2016 with total page 603 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook is a definitive, up-to-date, and succinct text covering the legislative requirements, scientific foundations, and clinical good practice necessary for clinical, academic, and healthcare research.
Author : Guy Healing
Publisher :
ISBN 13 : 9780367804763
Total Pages : 344 pages
Book Rating : 4.8/5 (47 download)
Download or read book Handbook of Pre-clinical Continuous Intravenous Infusion written by Guy Healing and published by . This book was released on 2000 with total page 344 pages. Available in PDF, EPUB and Kindle. Book excerpt: Any scientist or technician involved in pre-clinical drug studies knows that infusing animal models with test substances is no simple matter, especially if one wants to do it humanely as well as guarantee results that are not compromised by the procedure. The challenge becomes compounded if one is employing a variety of species. What works for a rat or mouse does not necessarily work for a rabbit or primate. The Handbook of Pre-clinical Continuous Intravenous Infusion answers the needs of researchers and technicians by providing complete instructions for a wide range of infusion techniques delivered to several species. With sections devoted to rats, mice, rabbits, dogs, mini-pigs, and nonhuman primates (both large and small), this thorough text gives step-by-step instructions for the use of a variety of techniques, and equipment. It includes procedures for multidose infusion toxicity and reproductive toxicology studies, and provides guidance on the use of a variety of equipment, including tail cuffs, harnesses, and implanted buttons. It also offers detailed information on surgical preparation for primates and mini-pigs, along with advice about the use of preoperative anesthesia, post surgical analgesics, and antibiotic administration, as well as valuable input on surgical suite design. "... I was amazed and gratified about the level of detail and the practical emphasis on technical expertise and animal well-being. This book is unique in having that as an overt aim." From the Foreword, David B. Morton, University of Birmingham, UKThe text concludes with a chapter on general non-species-specific information that discusses common pathological findings in continuous infusion studies, the use of mini-osmatic pumps, and controllable variables such as vehicles, rates of administration and volumes. With contributions from several established experts in the handling of pre-clinical animal models, this authoritative volume removes the need for any g
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309225493
Total Pages : 432 pages
Book Rating : 4.3/5 (92 download)
Download or read book Safe and Effective Medicines for Children written by Institute of Medicine and published by National Academies Press. This book was released on 2012-10-13 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.
Author : Richard H. Riley
Publisher : Oxford University Press
ISBN 13 : 0198717628
Total Pages : 483 pages
Book Rating : 4.1/5 (987 download)
Download or read book Manual of Simulation in Healthcare written by Richard H. Riley and published by Oxford University Press. This book was released on 2016 with total page 483 pages. Available in PDF, EPUB and Kindle. Book excerpt: Practising fundamental patient care skills and techniques is essential to the development of trainees' wider competencies in all medical specialties. After the success of simulation learning techniques used in other industries, such as aviation, this approach has been adopted into medical education. This book assists novice and experienced teachers in each of these fields to develop a teaching framework that incorporates simulation. The Manual of Simulation in Healthcare, Second Edition is fully revised and updated. New material includes a greater emphasis on patient safety, interprofessional education, and a more descriptive illustration of simulation in the areas of education, acute care medicine, and aviation. Divided into three sections, it ranges from the logistics of establishing a simulation and skills centre and the inherent problems with funding, equipment, staffing, and course development to the considerations for healthcare-centred simulation within medical education and the steps required to develop courses that comply with 'best practice' in medical education. Providing an in-depth understanding of how medical educators can best incorporate simulation teaching methodologies into their curricula, this book is an invaluable resource to teachers across all medical specialties.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309158060
Total Pages : 442 pages
Book Rating : 4.3/5 (91 download)
Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Author : Julian P. T. Higgins
Publisher : Wiley
ISBN 13 : 9780470699515
Total Pages : 672 pages
Book Rating : 4.6/5 (995 download)
Download or read book Cochrane Handbook for Systematic Reviews of Interventions written by Julian P. T. Higgins and published by Wiley. This book was released on 2008-11-24 with total page 672 pages. Available in PDF, EPUB and Kindle. Book excerpt: Healthcare providers, consumers, researchers and policy makers are inundated with unmanageable amounts of information, including evidence from healthcare research. It has become impossible for all to have the time and resources to find, appraise and interpret this evidence and incorporate it into healthcare decisions. Cochrane Reviews respond to this challenge by identifying, appraising and synthesizing research-based evidence and presenting it in a standardized format, published in The Cochrane Library (www.thecochranelibrary.com). The Cochrane Handbook for Systematic Reviews of Interventions contains methodological guidance for the preparation and maintenance of Cochrane intervention reviews. Written in a clear and accessible format, it is the essential manual for all those preparing, maintaining and reading Cochrane reviews. Many of the principles and methods described here are appropriate for systematic reviews applied to other types of research and to systematic reviews of interventions undertaken by others. It is hoped therefore that this book will be invaluable to all those who want to understand the role of systematic reviews, critically appraise published reviews or perform reviews themselves.
Author : Vera Mihajlovic-Madzarevic
Publisher : John Wiley & Sons
ISBN 13 : 0470920882
Total Pages : 186 pages
Book Rating : 4.4/5 (79 download)
Download or read book Clinical Trials Audit Preparation written by Vera Mihajlovic-Madzarevic and published by John Wiley & Sons. This book was released on 2010-09-29 with total page 186 pages. Available in PDF, EPUB and Kindle. Book excerpt: A must-have guide for any professional in the drug manufacturing industry The Good Clinical Practice (GCP) audit is a tedious but necessary exercise that assures that all parties do their job properly and in compliance with the applicable FDA code. Clinical Trials Audit Preparation demystifies the audit process for all parties involved, including clinical research sponsors, clinical investigators, and institutional review boards. This book provides a step-by-step explanation of the FDA audit procedures for clinical trials and of how pharmaceutical companies, clinical investigators, and institutional review boards should prepare for regulatory audits. The book emphasizes the processes and procedures that should be implemented before a clinical audit occurs, making this an imperative guide to any professional in the drug manufacturing industry, including drug manufacturing companies, regulatory affairs personnel, clinical investigators, and quality assurance professionals. Among the topics discussed: Good Clinical Practices and therapeutic product development in clinical research The roles of the sponsor of a clinical investigation, the IRB, or independent ethics committee The roles and responsibilities of the clinical trial investigator The inspection preparation The Audit Report and the Form 483 Warning letters issued to clinical investigators and clinical trial sponsors and their impact on product development
Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309154006
Total Pages : 246 pages
Book Rating : 4.3/5 (91 download)
Download or read book Guide for the Care and Use of Laboratory Animals written by National Research Council and published by National Academies Press. This book was released on 2011-01-27 with total page 246 pages. Available in PDF, EPUB and Kindle. Book excerpt: A respected resource for decades, the Guide for the Care and Use of Laboratory Animals has been updated by a committee of experts, taking into consideration input from the scientific and laboratory animal communities and the public at large. The Guide incorporates new scientific information on common laboratory animals, including aquatic species, and includes extensive references. It is organized around major components of animal use: Key concepts of animal care and use. The Guide sets the framework for the humane care and use of laboratory animals. Animal care and use program. The Guide discusses the concept of a broad Program of Animal Care and Use, including roles and responsibilities of the Institutional Official, Attending Veterinarian and the Institutional Animal Care and Use Committee. Animal environment, husbandry, and management. A chapter on this topic is now divided into sections on terrestrial and aquatic animals and provides recommendations for housing and environment, husbandry, behavioral and population management, and more. Veterinary care. The Guide discusses veterinary care and the responsibilities of the Attending Veterinarian. It includes recommendations on animal procurement and transportation, preventive medicine (including animal biosecurity), and clinical care and management. The Guide addresses distress and pain recognition and relief, and issues surrounding euthanasia. Physical plant. The Guide identifies design issues, providing construction guidelines for functional areas; considerations such as drainage, vibration and noise control, and environmental monitoring; and specialized facilities for animal housing and research needs. The Guide for the Care and Use of Laboratory Animals provides a framework for the judgments required in the management of animal facilities. This updated and expanded resource of proven value will be important to scientists and researchers, veterinarians, animal care personnel, facilities managers, institutional administrators, policy makers involved in research issues, and animal welfare advocates.
