Handbook of SOPs for Good Clinical Practice, Second Edition

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Publisher : CRC Press
ISBN 13 : 9780849321818
Total Pages : 288 pages
Book Rating : 4.3/5 (218 download)

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Book Synopsis Handbook of SOPs for Good Clinical Practice, Second Edition by : Celine Clive

Download or read book Handbook of SOPs for Good Clinical Practice, Second Edition written by Celine Clive and published by CRC Press. This book was released on 2004-02-17 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: Completely revised and updated, the second edition of a classic reference, Handbook of SOPs for Good Clinical Practice provides templates of SOPs ready for adaptation to your requirements and immediate use. This allows you to create new SOPs or benchmark your existing SOPs against an internationally accepted set of SOPs. The book includes a CD-ROM containing an electronic copy of each of the SOPs and forms in the handbook so that you can easily customize the text to reflect your organization's processes. The author uses language ranging from the specific to the very general, depending on the activity described and the number of the existing regulations governing the activity. This provides you with a starting point for the development of your organization's SOPs, saving you the time and money that would normally be spent researching and documenting each of the procedures described. Modifying the SOPs supplied by this book will be a much more efficient task than developing new ones from scratch. Containing templates for SOPs and forms applicable to sponsors, study sites, and Institutional Review Boards (IRBs), Handbook of SOPs for Good Clinical Practice, Second Edition gives you the tools needed to develop effective SOPs for your organization.

A Handbook of SOPs for Good Clinical Practice

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Publisher : CRC Press
ISBN 13 : 9781574910094
Total Pages : 286 pages
Book Rating : 4.9/5 (1 download)

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Book Synopsis A Handbook of SOPs for Good Clinical Practice by : Donald E. Maynard

Download or read book A Handbook of SOPs for Good Clinical Practice written by Donald E. Maynard and published by CRC Press. This book was released on 1996-02-28 with total page 286 pages. Available in PDF, EPUB and Kindle. Book excerpt: This classic SOP handbook provides twenty-one SOPs ready for immediate use or for adaptation to readers' requirements, allowing them to benchmark their existing SOPs against an internationally accepted set of SOPs. It contains SOPs applicable to the four major entities in the clinical development process: the sponsor, the clinical monitor, the investigator, and the Institutional Review board. The language ranges from the specific to the very general, depending on the activity described and the number and breadth of the existing regulations governing it. The handbook gives readers blueprints for setting up the procedural guidelines their companies need.

Writing and Managing SOPs for GCP

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Publisher : CRC Press
ISBN 13 : 1482239361
Total Pages : 224 pages
Book Rating : 4.4/5 (822 download)

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Book Synopsis Writing and Managing SOPs for GCP by : Susanne Prokscha

Download or read book Writing and Managing SOPs for GCP written by Susanne Prokscha and published by CRC Press. This book was released on 2015-07-29 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt: Writing and Managing SOPs for GCP is the first book to discuss managing Standard Operating Procedures (SOPs) for Good Clinical Practice (GCP) from conception to retirement. It recommends approaches that have a direct impact on improving SOP and regulatory compliance. Throughout the text, the book provides a user’s point of view to keep topics focused on the practical aspects of SOPs and SOP management. The idea of specifically calling out approaches to SOP creation and maintenance in an effort to make it easier for users to stay in compliance is a theme found throughout all book chapters. Examples in each chapter provide accurate reflections of real-world experiences to illustrate the discussion. The book also includes an example "SOP of SOPs" along with an associated SOP template.

Good Clinical Practice Guide

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Publisher :
ISBN 13 : 9780988193802
Total Pages : 216 pages
Book Rating : 4.1/5 (938 download)

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Book Synopsis Good Clinical Practice Guide by : Gary L. Chadwick

Download or read book Good Clinical Practice Guide written by Gary L. Chadwick and published by . This book was released on 2012-09-17 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Good Clinical Practice (GCP) Guide is a logical extension of the CITI Program's web-based Good Clinical Practice (GCP) training, and is based on the CITI Program's recognized content. It is intended to serve as a quick reference guide for GCP using Drugs and Biologics as well as Devices.

Good Clinical Practice

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Publisher : John Wiley & Sons
ISBN 13 :
Total Pages : 214 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Good Clinical Practice by : Josef Kolman

Download or read book Good Clinical Practice written by Josef Kolman and published by John Wiley & Sons. This book was released on 1998 with total page 214 pages. Available in PDF, EPUB and Kindle. Book excerpt: Good Clinical Practice Standard Operating Procedures for Clinical Researchers Edited by Josef Kolman MPRC - Medical Pharmaceutical Research Center Ltd. Vienna, Austria Paul Meng PMC - Dr Paul Meng Consultant, Vienna, Austria and Graeme Scott Professional Services in Clinical Research, Edinburgh, Scotland There is a growing trend for investigators to adopt a more formal approach to the procedures applied to various stages of clinical trials. Most environments employ some form of standard operating procedures which are designed to be used as 'working tools' within that particular field, e.g. standard operating procedures in hospitals for doctors and nurses. With rigorous standards of good clinical practice being applied to all areas, optimizing the design and use of standard operating procedures is more in demand every day. Topics covered include: * A brief description of the history and development of clinical research and good clinical practice * An explanation of what standard operating procedures are and how they work * A selection of actual standard operating procedures and checklists This well-constructed and timely work, set out in a logical, sequential order provides the necessary material needed to develop a useful set of investigator standard operating procedures.

Handbook of Bioequivalence Testing, Second Edition

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Publisher : CRC Press
ISBN 13 : 1482226375
Total Pages : 1012 pages
Book Rating : 4.4/5 (822 download)

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Book Synopsis Handbook of Bioequivalence Testing, Second Edition by : Sarfaraz K. Niazi

Download or read book Handbook of Bioequivalence Testing, Second Edition written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2014-10-29 with total page 1012 pages. Available in PDF, EPUB and Kindle. Book excerpt: As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct adequate, efficient bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence. In addition, advances in the analytical technology used to detect drug and metabolite levels have made bioequivalence testing more complex. The second edition of Handbook of Bioequivalence Testing has been completely updated to include the most current information available, including new findings in drug delivery and dosage form design and revised worldwide regulatory requirements. New topics include: A historical perspective on generic pharmaceuticals New guidelines governing submissions related to bioequivalency studies, along with therapeutic code classifications Models of noninferiority Biosimilarity of large molecule drugs Bioequivalence of complementary and alternate medicines Bioequivalence of biosimilar therapeutic proteins and monoclonal antibodies New FDA guidelines for bioanalytical method validation Outsourcing and monitoring of bioequivalence studies The cost of generic drugs is rising much faster than in the past, partly because of the increased costs required for approval—including those for bioequivalence testing. There is a dire need to re-examine the science behind this type of testing to reduce the burden of development costs—allowing companies to develop generic drugs faster and at a lower expense. The final chapter explores the future of bioequivalence testing and proposes radical changes in the process of biowaivers. It suggests how the cost of demonstrating bioequivalence can be reduced through intensive analytical investigation and proposes that regulatory agencies reduce the need for bioequivalence studies in humans. Backed by science and updated with the latest research, this book is destined to spark continued debate on the efficacy of the current bioequivalence testing paradigm.

Standard Operating Procedures for Good Clinical Practice by Sponsors of Global Clinical

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Publisher :
ISBN 13 : 9781933040059
Total Pages : pages
Book Rating : 4.0/5 (4 download)

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Book Synopsis Standard Operating Procedures for Good Clinical Practice by Sponsors of Global Clinical by : Thomson American Health Consultants

Download or read book Standard Operating Procedures for Good Clinical Practice by Sponsors of Global Clinical written by Thomson American Health Consultants and published by . This book was released on 2004-01-01 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

A Concise Guide to Clinical Trials

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Publisher : John Wiley & Sons
ISBN 13 : 1444356666
Total Pages : 184 pages
Book Rating : 4.4/5 (443 download)

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Book Synopsis A Concise Guide to Clinical Trials by : Allan Hackshaw

Download or read book A Concise Guide to Clinical Trials written by Allan Hackshaw and published by John Wiley & Sons. This book was released on 2011-09-07 with total page 184 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical trials have revolutionized the way disease is prevented, detected and treated, and early death avoided, and they continue to be an expanding area of research. They are central to the work of pharmaceutical companies, and there are many academic and public sector organizations that conduct trials on a wide variety of interventions, including drugs, devices, surgical techniques, and changes in behaviour and lifestyle. A Concise Guide to Clinical Trials provides a comprehensive yet easy-to-read overview of the design, conduct and analysis of trials. It requires no prior knowledge on the subject as the important concepts are introduced throughout. There are chapters that distinguish between the different types of trials, and an introduction to systematic reviews, health-related quality of life and health economic evaluation. The book also covers the ethical and legal requirements in setting up a clinical trial due to an increase in governance responsibilities and regulations. This practical guidebook is ideal for busy clinicians and other health professionals who do not have enough time to attend courses or search through extensive textbooks. It will help anyone involved in undertaking clinical research, or those reading about trials. The book is aimed at: Those wishing to learn about clinical trials for the first time, or as a quick reference guide, for example as part of a taught course on clinical trials Health professionals who wish to conduct their own trials, or participate in other people’s studies People who work in pharmaceutical companies, grant funding organisations, or regulatory agencies

Handbook of Non-Invasive Methods and the Skin, Second Edition

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Publisher : CRC Press
ISBN 13 : 1420003305
Total Pages : 1056 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Handbook of Non-Invasive Methods and the Skin, Second Edition by : Jorgen Serup

Download or read book Handbook of Non-Invasive Methods and the Skin, Second Edition written by Jorgen Serup and published by CRC Press. This book was released on 2006-02-23 with total page 1056 pages. Available in PDF, EPUB and Kindle. Book excerpt: Firmly established as the leading international reference in this field, Non-Invasive Methods and the Skin broke new ground with its comprehensive coverage of methods used in both clinical and experimental dermatology. Completely revised and updated, containing more than twice as much information, the Second Edition continues the tradition. The authors' thorough research and clear organization make this book a baseline reference for those using noninvasive biophysical methods to study the skin. Arranged by physical modality and structured to provide educational and practical information, the second edition, like its predecessor, will prove to be of value to young researchers and senior scientists alike. The coverage of major evaluation and measurement methods share a consistent format, including scope, sources of error, application, and validity. This edition incorporates 69 revised chapters with more than 90 new chapters covering topics such as computer technique, imaging techniques, skin friction, barrier functions, and more. New chapters provide coverage of: computers, computer techniques, and image analysis imaging techniques, including clinical photography legal situations and guidelines behind instrumental use skin friction barrier functions important new techniques such as in vitro confocal microscopy, OCT, and Raman spectroscopy veterinary/animal research use of methods The truly interdisciplinary, international panel of contributors includes experts from the specialties of dermatology, bioengineering, pathology, manufacturing engineering, medical physics, pharmacology, microbiology, neurology, surgery, obstetrics and gynecology, cardiovascular research, and pharmacy from academic institutions and hospitals in countries such as Denmark, Germany, the United Kingdom, the United States, Japan, Israel, Taiwan, and Singapore. The revision is extensive and covers a broad spectrum of methods while providing the same caliber of authoritative information that made the previous edition so popular. Application oriented, practical, and instructive, this Second Edition will meet the needs of the researchers today, and in years to come.

The CRC's Guide to Coordinating Clinical Research

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Author :
Publisher : CenterWatch
ISBN 13 :
Total Pages : 428 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis The CRC's Guide to Coordinating Clinical Research by : Karen E. Woodin

Download or read book The CRC's Guide to Coordinating Clinical Research written by Karen E. Woodin and published by CenterWatch. This book was released on 2004 with total page 428 pages. Available in PDF, EPUB and Kindle. Book excerpt: This guidebook is filled with valuable information on the role and responsibilities of a clinical research coordinator (CRC) and explains the research process from the site and CRC perspective. Topics covered include: identifying the regulations governing clinical research; describing the drug development process; discussing good clinical practices and how to apply them in clinical trials and organizing a clinical practice.

Standard Operating Procedures for Good Clinical Practice by Sponsors

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Publisher :
ISBN 13 : 9781933040240
Total Pages : pages
Book Rating : 4.0/5 (42 download)

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Book Synopsis Standard Operating Procedures for Good Clinical Practice by Sponsors by : Thomson American Health Consultants

Download or read book Standard Operating Procedures for Good Clinical Practice by Sponsors written by Thomson American Health Consultants and published by . This book was released on 2005-01-01 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Batch Effects and Noise in Microarray Experiments

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Publisher : John Wiley & Sons
ISBN 13 : 0470741384
Total Pages : 292 pages
Book Rating : 4.4/5 (77 download)

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Book Synopsis Batch Effects and Noise in Microarray Experiments by : Andreas Scherer

Download or read book Batch Effects and Noise in Microarray Experiments written by Andreas Scherer and published by John Wiley & Sons. This book was released on 2009-12-14 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: Batch Effects and Noise in Microarray Experiments: Sources and Solutions looks at the issue of technical noise and batch effects in microarray studies and illustrates how to alleviate such factors whilst interpreting the relevant biological information. Each chapter focuses on sources of noise and batch effects before starting an experiment, with examples of statistical methods for detecting, measuring, and managing batch effects within and across datasets provided online. Throughout the book the importance of standardization and the value of standard operating procedures in the development of genomics biomarkers is emphasized. Key Features: A thorough introduction to Batch Effects and Noise in Microrarray Experiments. A unique compilation of review and research articles on handling of batch effects and technical and biological noise in microarray data. An extensive overview of current standardization initiatives. All datasets and methods used in the chapters, as well as colour images, are available on www.the-batch-effect-book.org, so that the data can be reproduced. An exciting compilation of state-of-the-art review chapters and latest research results, which will benefit all those involved in the planning, execution, and analysis of gene expression studies.

Validation Compliance Biannual 1996-1997

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Publisher : CRC Press
ISBN 13 : 9780824797461
Total Pages : 860 pages
Book Rating : 4.7/5 (974 download)

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Book Synopsis Validation Compliance Biannual 1996-1997 by : International Validation Forum

Download or read book Validation Compliance Biannual 1996-1997 written by International Validation Forum and published by CRC Press. This book was released on 1996-04-10 with total page 860 pages. Available in PDF, EPUB and Kindle. Book excerpt: This biannual offers detailed coverage of the regulations, requirements, and techniques for the validation of processes and systems used in regulated international industries. It addresses significant requirements for pharmaceutical, medical device, and biologic companies as well as environmental laboratories. It examines Good Manufacturing Principles (GMPs), Good Clinical Practices (GCPs), Good Laboratory Practices (GLPs), Good Automated Library Practices (GALPs), and others, and elucidates up-to-the-minute industry changes and international concerns.

Guide to Good Clinical Practice

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Publisher :
ISBN 13 : 9781930872639
Total Pages : pages
Book Rating : 4.8/5 (726 download)

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Book Synopsis Guide to Good Clinical Practice by : Jeffrey Schomisch

Download or read book Guide to Good Clinical Practice written by Jeffrey Schomisch and published by . This book was released on 2006-01-01 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Practical Guide to Clinical Data Management

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Publisher : CRC Press
ISBN 13 : 1420007882
Total Pages : 254 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Practical Guide to Clinical Data Management by : Susanne Prokscha

Download or read book Practical Guide to Clinical Data Management written by Susanne Prokscha and published by CRC Press. This book was released on 2006-08-01 with total page 254 pages. Available in PDF, EPUB and Kindle. Book excerpt: The management of clinical data, from its collection to its extraction for analysis, has become a critical element in the steps to prepare a regulatory submission and to obtain approval to market a treatment. As its importance has grown, clinical data management (CDM) has changed from an essentially clerical task in the late 1970s and early 1980s t

Good Clinical Practice

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Publisher : Parexel International Corporation
ISBN 13 : 9781882615933
Total Pages : 689 pages
Book Rating : 4.6/5 (159 download)

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Book Synopsis Good Clinical Practice by : Mark P. Mathieu

Download or read book Good Clinical Practice written by Mark P. Mathieu and published by Parexel International Corporation. This book was released on 2010-01-01 with total page 689 pages. Available in PDF, EPUB and Kindle. Book excerpt: Newly updated and expanded for 2010, this industry-leading GCP training and reference guide answers approximately 700 of the most common and difficult questions regarding the day-to-day interpretation and implementation of GCP standards for drugs and biologics. While continuing with a U.S./FDA focus, this innovative reference pocket guide has now been expanded to provide even more information on not just US GCP, but international GCP issues in such regions and countries as the European Union, India, Latin America and Russia! Find out for yourself why more and more leading pharma and biotech companies are using this reference guide to educate their clinical professionals, trial auditors, and site staff on the many emerging complexities of GCP standards. The completely updated and expanded 2010 guide includes: * 60+ pages of all-new Q&As, including questions addressing emerging topics such as the use of social media in clinical trials, and the implications of IRB reviews of social media content used for patient recruitment. * A new chapter featuring exclusive interviews with Leslie Ball, M.D., director of CDER's Division of Scientific Investigations (DSI), and Joanne Less, M.D., director of FDA's Good Clinical Practice Program on the priorities and direction of the FDA's GCP enforcement programs. * Completely new and updated section featuring all the latest data and trends on the FDA's clinical trial compliance inspections, inspectional findings, and common areas of GCP noncompliance. * 200+ Q&As updated to reflect the very latest FDA guidances, regulations, comments, and developments. Read how the FDA will now be focusing more intently on sponsors' quality systems when significant problems are discovered at clinical study site, why the rate of significant non-compliance is being discovered at clinical trial sites, and how increasing numbers of new drug reviews are being delayed due to GCP compliance issues. In one pocket handbook, you'll have authoritative answers to hundreds of common and emerging questions, in 20+ GCP-related areas, right at your fingertips: * FDA and ICH GCP Standards for Clinical Research * Form FDA 1572-Statement of Investigator * Informed Consent * Patient Recruitment * State Standards and GCP * Source Data/Documentation * Investigator/Site Requirements * Clinical Monitoring * Clinical Study Safety Reporting * Clinical Trial Protocols/Protocol Changes/Protocol Violations * Institutional Review Boards * Quality Assurance Activities/Study Auditing/FDA Inspections * Investigational Drug Accountability, Administration, and Labeling * Now includes a new section on GCP in Latin America! * Also provides all FDA, ICH, and EU GCP-related regulations and guidances in one source!

The CRA's Guide to Monitoring Clinical Research

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Author :
Publisher : CenterWatch
ISBN 13 : 9781930624375
Total Pages : 448 pages
Book Rating : 4.6/5 (243 download)

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Book Synopsis The CRA's Guide to Monitoring Clinical Research by : Karen E. Woodin

Download or read book The CRA's Guide to Monitoring Clinical Research written by Karen E. Woodin and published by CenterWatch. This book was released on 2003-01-01 with total page 448 pages. Available in PDF, EPUB and Kindle. Book excerpt: