Quick Guide To Good Clinical Practice
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Quick Guide To Good Clinical Practice
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Author : Cemal Cingi
language : en
Publisher: Springer
Release Date : 2016-11-15
Quick Guide To Good Clinical Practice written by Cemal Cingi and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-11-15 with Medical categories.
This brand-new book offers a reference guide to understanding and applying the rules for properly conducting clinical trials to meet the international quality standard – Good Clinical Practice – provided by the International Conference on Harmonization (ICH). The work offers an updated perspective on the clinical research landscape within the context of the clinical trial regulatory frameworks in Europe and the USA. In addition to providing a historical review and a detailed definition of GPC regulations, it includes step-by-step explanations of all the requirements that researchers should bear in mind when designing and performing new trials. Further topics covered include: ethics of clinical research; the drug development process and evolution of regulations; investigator and sponsor responsibilities; and clinical trial protocols. Written by clinicians for clinicians, the book represents a valuable read also for researchers, pharmacists and all professionals involved in applications to the ethic committees, whose approval is required for new clinical studies.
Good Clinical Practice Guide
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Author : Gary L. Chadwick
language : en
Publisher:
Release Date : 2012-09-17
Good Clinical Practice Guide written by Gary L. Chadwick and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-09-17 with categories.
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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Author :
language : en
Publisher:
Release Date : 2010
Good Clinical Practice written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010 with Clinical trials categories.
The Fundamentals Of Clinical Research
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Author : P. Michael Dubinsky
language : en
Publisher: John Wiley & Sons
Release Date : 2022-01-26
The Fundamentals Of Clinical Research written by P. Michael Dubinsky 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 2022-01-26 with Medical categories.
This book focuses on the practical application of good clinical practice (GCP) fundamentals and provides insight into roles and responsibilities included in planning, executing, and analyzing clinical trials. The authors describe the design of quality into clinical trial planning and the application of regulatory, scientific, administrative, business, and ethical considerations. Describes the design of quality into the clinical trial planning Has end-of-chapter questions and answers to check learning and comprehension Includes charts that visually summarize the content and allow readers to cross-reference details in relevant chapters Offers a companion website containing supplemental training resources
Easy Guide To Clinical Practice Improvement
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Author : New South Wales. Health Department
language : en
Publisher:
Release Date : 2002
Easy Guide To Clinical Practice Improvement written by New South Wales. Health Department and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2002 with Clinical medicine categories.
Dosage Form Design Parameters
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Author :
language : en
Publisher: Academic Press
Release Date : 2018-07-25
Dosage Form Design Parameters written by and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-07-25 with Medical categories.
Dosage Form Design Parameters, Volume II, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries. Examines the history and recent developments in drug dosage forms for pharmaceutical sciences Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism Contains extensive references for further discovery and learning that are appropriate for advanced undergraduates, graduate students and those interested in drug dosage design
Guide For Clinical Trial Staff
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Author : Gerhard Fortwengel
language : en
Publisher: Karger Medical and Scientific Publishers
Release Date : 2004
Guide For Clinical Trial Staff written by Gerhard Fortwengel and has been published by Karger Medical and Scientific Publishers this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004 with Medical categories.
The standard to which clinical trials must conform is called 'Good Clinical Practice' (GCP). GCP is defined as a standard that ensures adequate protection of subjects participating in clinical trials; furthermore, it ensures that all trial activities and data are meticulously documented and reported. The latest GCP guideline was developed by the International Conference on Harmonization (ICH) and was first published in May 1996. This guideline is based on ethical principles that have their origin in the Declaration of Helsinki (1964, last modified in October 2000). Besides GCP, clinical trials must also comply with the local law of the country where the study is being conducted. This book will be an indispensable companion for those conducting clinical trials and should have a fixed place in the library of every investigator and his staff.
Principles Of Good Clinical Practice
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Author : Michael J. McGraw
language : en
Publisher: Pharmaceutical Press
Release Date : 2010
Principles Of Good Clinical Practice written by Michael J. McGraw and has been published by Pharmaceutical Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010 with Business & Economics categories.
Part of "RPS Pharmacy Business Administration Series", this book offers good clinical practice guidelines. It includes standards on how clinical trials should be conducted, provide assurance of safety and efficacy of various drugs and protect human rights.
Good Clinical Practice
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Author :
language : en
Publisher:
Release Date : 2018
Good Clinical Practice written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018 with categories.
Clinical Practice Guideline
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Author :
language : en
Publisher:
Release Date : 1992
Clinical Practice Guideline written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1992 with categories.