Oecd Series On Principles Of Good Laboratory Practice And Compliance Monitoring The Application Of The Principles Of Glp To In Vitro Studies
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Oecd Series On Principles Of Good Laboratory Practice And Compliance Monitoring The Application Of The Principles Of Glp To In Vitro Studies
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Author : OECD
language : en
Publisher: OECD Publishing
Release Date : 2004-12-01
Oecd Series On Principles Of Good Laboratory Practice And Compliance Monitoring The Application Of The Principles Of Glp To In Vitro Studies written by OECD and has been published by OECD Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004-12-01 with categories.
This document facilitates the proper application and interpretation of the GLP Principles for the organisation and management of in vitro studies, and provides guidance for the appropriate application of the GLP Principles to in vitro studies.
Oecd Series On Principles Of Good Laboratory Practice And Compliance Monitoring Establishment And Control Of Archives That Operate In Compliance With The Principles Of Glp
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Author : OECD
language : en
Publisher: OECD Publishing
Release Date : 2007-06-11
Oecd Series On Principles Of Good Laboratory Practice And Compliance Monitoring Establishment And Control Of Archives That Operate In Compliance With The Principles Of Glp written by OECD and has been published by OECD Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-06-11 with categories.
This document provides guidance concerning the establishment and control of archives compliant with the principles of Good Laboratory Practice, and is intended for use by test facilities, contract archives and quality assurance units and comliance authorities.
Oecd Series On Principles Of Good Laboratory Practice And Compliance Monitoring Guidance On The Glp Requirements For Peer Review Of Histopathology
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Author : OECD
language : en
Publisher: OECD Publishing
Release Date : 2015-01-02
Oecd Series On Principles Of Good Laboratory Practice And Compliance Monitoring Guidance On The Glp Requirements For Peer Review Of Histopathology written by OECD and has been published by OECD Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-01-02 with categories.
This document provides guidance to pathologists, test facility management, study directors and quality assurance personnel on how the peer review of histopathology should be planned, managed, documented and reported in order to meet GLP expectations and requirements.
Oecd Series On Testing And Assessment Guidance Document On Good In Vitro Method Practices Givimp
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Author : OECD
language : en
Publisher: OECD Publishing
Release Date : 2018-12-10
Oecd Series On Testing And Assessment Guidance Document On Good In Vitro Method Practices Givimp written by OECD and has been published by OECD Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-12-10 with categories.
In the past several decades, there has been a substantial increase in the availability of in vitro test methods for evaluating chemical safety in an international regulatory context. To foster confidence in in vitro alternatives to animal testing, the test methods and conditions under which ...
Good Laboratory Practice Oecd Principles And Guidance For Compliance Monitoring
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Author : OECD
language : en
Publisher: OECD Publishing
Release Date : 2005-12-16
Good Laboratory Practice Oecd Principles And Guidance For Compliance Monitoring written by OECD and has been published by OECD Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005-12-16 with categories.
This publication unites all of the OECD documents related to Good Laboratory Practice and compliance monitoring, and, in the Annex, reproduces the three OECD Council Decisions related to the Mutual Acceptance of Data in the Assessment of Chemicals.
Encyclopedia Of Biopharmaceutical Statistics Four Volume Set
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Author : Shein-Chung Chow
language : en
Publisher: CRC Press
Release Date : 2018-09-03
Encyclopedia Of Biopharmaceutical Statistics Four Volume Set written by Shein-Chung Chow and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-09-03 with Medical categories.
Since the publication of the first edition in 2000, there has been an explosive growth of literature in biopharmaceutical research and development of new medicines. This encyclopedia (1) provides a comprehensive and unified presentation of designs and analyses used at different stages of the drug development process, (2) gives a well-balanced summary of current regulatory requirements, and (3) describes recently developed statistical methods in the pharmaceutical sciences. Features of the Fourth Edition: 1. 78 new and revised entries have been added for a total of 308 chapters and a fourth volume has been added to encompass the increased number of chapters. 2. Revised and updated entries reflect changes and recent developments in regulatory requirements for the drug review/approval process and statistical designs and methodologies. 3. Additional topics include multiple-stage adaptive trial design in clinical research, translational medicine, design and analysis of biosimilar drug development, big data analytics, and real world evidence for clinical research and development. 4. A table of contents organized by stages of biopharmaceutical development provides easy access to relevant topics. About the Editor: Shein-Chung Chow, Ph.D. is currently an Associate Director, Office of Biostatistics, U.S. Food and Drug Administration (FDA). Dr. Chow is an Adjunct Professor at Duke University School of Medicine, as well as Adjunct Professor at Duke-NUS, Singapore and North Carolina State University. Dr. Chow is the Editor-in-Chief of the Journal of Biopharmaceutical Statistics and the Chapman & Hall/CRC Biostatistics Book Series and the author of 28 books and over 300 methodology papers. He was elected Fellow of the American Statistical Association in 1995.
Regulated Bioanalytical Laboratories
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Author : Michael Zhou
language : en
Publisher: John Wiley & Sons
Release Date : 2011-03-31
Regulated Bioanalytical Laboratories written by Michael Zhou 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 2011-03-31 with Science categories.
This book provides useful information for bioanalytical / analytical scientists, analysts, quality assurance managers, and all personnel in bioanalytical laboratories through all aspects of bioanalytical technical and regulatory perspectives within bioanalytical operations and processes. Readers learn how to develop and implement strategies for routine, non-routine, and standard bioanalytical methods and on the entire equipment hardware and software qualification process. The book also gives guidelines on qualification of certified standards and in-house reference material as well as on people qualification. Finally, it guides readers through stressless internal and third party laboratory audits and inspections. It takes account to most national and international regulations and quality and accreditation standards, along with corresponding interpretation and inspection guides. The author elaborates on highly comprehensive content, making it easy not only to learn the subject but also to quickly implement the recommendations.
Principles Of Toxicology Testing
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Author : Frank A. Barile
language : en
Publisher: CRC Press
Release Date : 2007-07-23
Principles Of Toxicology Testing written by Frank A. Barile and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-07-23 with Medical categories.
The evolution of toxicology testing finds its impetus in the continuing growth of the chemical and pharmaceutical industries, as well as the awareness of public health initiatives, needs, and responses that demand faster, more accurate, more economical methods for screening potential toxicity. Concurrent advances in biotechnology enable viable in v
Good Laboratory Practice Training Manual
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2010-02-02
Good Laboratory Practice Training Manual written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-02-02 with Medical categories.
This manual is designed to be used by the trainee at Special Program for Research and Training in Tropical Diseases and Good Laboratory Practice training workshops. It contains an introduction which highlights the history of the OECD principles of GLP, and the fundamental points. Included is training on the resources required (personnel and facilities); preparation of the protocol and standard operating procedures (SOPs); characterization of the test item (its storage, use, quality control, test system); documentation (reporting, deviations from the protocol, indexing, archiving, retrieval); and quality assurance (validity of results must be ensured through all phases of a study). The material is presented in a clear, lively and informative way. Also included are several practical and interesting workshops on how to prepare, review and improve protocols and standard operating procedures, based on actual case studies. Finally there is a self-assessment questionnaire-so the trainee can recognize how much he/she has learned and what issues need clarification, if any.
Early Drug Development
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Author : Mitchell N. Cayen
language : en
Publisher: John Wiley & Sons
Release Date : 2011-02-25
Early Drug Development written by Mitchell N. Cayen 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 2011-02-25 with Medical categories.
The focus of early drug development has been the submission of an Investigational New Drug application to regulatory agencies. Early Drug Development: Strategies and Routes to First-in-Human Trials guides drug development organizations in preparing and submitting an Investigational New Drug (IND) application. By explaining the nuts and bolts of preclinical development activities and their interplay in effectively identifying successful clinical candidates, the book helps pharmaceutical scientists determine what types of discovery and preclinical research studies are needed in order to support a submission to regulatory agencies.