[PDF] The Role And Responsibilities Of The Study Director In Glp Studies eBook

Author : Organisation for Economic Co-operation and Development
Publisher :
Page : 12 pages
File Size : 45,9 MB
Release : 1999
Category : Laboratories
ISBN :

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This document defines the roles and responsibilities of the Study Director in Good Laboratory Practice studies.

Author : William J. Brock
Publisher : John Wiley & Sons
Page : 568 pages
File Size : 24,33 MB
Release : 2014-06-03
Category : Science
ISBN : 1118370392

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A single-source reference with a broad and holistic overview of nonclinical studies, this book offers critical training material and describes regulations of nonclinical testing through guidelines, models, case studies, practical examples, and worldwide perspectives. The book: Provides a complete overview of nonclinical study organization, conduct, and reporting and describes the roles and responsibilities of a Study Director to manage an effective study Covers regulatory and scientific concepts, including international testing and Good Laboratory Practice (GLP), compliance with guidelines, and animal models Features a concluding chapter that compiles case studies / lessons learned from those that have served as a Study Director for many years Addresses the entire spectrum of nonclinical testing, making it applicable to those in the government, laboratories and those actively involved in in all sectors of industry

Author : OECD
Publisher : OECD Publishing
Page : 42 pages
File Size : 50,74 MB
Release : 1999-10-06
Category :
ISBN : 9264173706

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These principles of corporate governance, endorsed by the OECD Council at Ministerial level in 1999, provide guidelines and standards to insure inclusion, accountability and abilit to attract capital.

Author : World Health Organization
Publisher : World Health Organization
Page : 328 pages
File Size : 27,32 MB
Release : 2010-02-02
Category : Medical
ISBN : 9241547553

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A new edition of one of Zola's lesser-known novels from the Rougon-Macquart Cycle Finding the young Angélique on their doorstep one Christmas Eve, the pious Hubert couple decide to bring her up as their own. As the girl grows up in the vicinity of the town's towering cathedral and learns her parents' trade of embroidery, she becomes increasingly fascinated by the lives of the saints, a passion fueled by her reading of the Golden Legend and other mystical Christian writings. One day love, in the shape of Félicien Hautecoeur, enters the dream world she has constructed around herself, bringing about upheaval and distress. Although it provides a detailed portrait of provincial 19th-century life and it adheres to a naturalist approach, The Dream eschews many of the characteristics of Zola's other novels of the Rougon-Macquart cycle—such as a pronounced polemical agenda or a gritty subject matter—offering instead a timeless, lyrical tale of love and innocence.

Author : David Mantus
Publisher : CRC Press
Page : 402 pages
File Size : 38,64 MB
Release : 2014-02-28
Category : Medical
ISBN : 1040079180

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FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise and jargon-free text demystifies the inner workings of the US Food and Drug Administration (FDA) and facilitates an understanding of how the agency operates with respect to compliance and product approval, including clinical trial exemptions, fast track status, advisory committee procedures, and more. The Third Edition of this highly successful publication: Examines the harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations on human drug, biologics and device development, research, manufacturing, and marketing Includes contributions from experts at organizations such as the FDA, National Institutes of Health (NIH), and PAREXEL Focuses on the new drug application (NDA) process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements Provides updates to the FDA Safety and Innovation Act (FDASIA), incorporating pediatric guidelines and follow-on biologics regulations from the 2012 Prescription Drug User Fee Act (PDUFA) V Explains current FDA inspection processes, enforcement options, and how to handle FDA meetings and required submissions Co-edited by an industry leader (Mantus) and a respected academic (Pisano), FDA Regulatory Affairs, Third Edition delivers a compilation of the selected US laws and regulations as well as a straightforward commentary on the FDA product approval process that’s broadly useful to both business and academia.

Author : Ray Proudlock
Publisher : Academic Press
Page : 458 pages
File Size : 11,77 MB
Release : 2016-05-28
Category : Medical
ISBN : 0128010061

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Genetic Toxicology Testing: A Laboratory Manual presents a practical guide to genetic toxicology testing of chemicals in a GLP environment. The most commonly used assays are described, from laboratory and test design to results analysis. In a methodical manner, individual test methods are described step-by-step, along with equipment, suggested suppliers, recipes for reagents, and evaluation criteria. An invaluable resource in the lab, this book will help to troubleshoot any assay problems you may encounter to optimise quality and efficiency in your genetic toxicology tests. Genetic Toxicology Testing: A Laboratory Manual is an essential reference for those new to the genetic toxicology laboratory, or anyone involved in setting up their own. Offers practical and consistent guidance on the most commonly-performed tests and procedures in a genetic toxicology lab Describes standard genetic toxicology assays, their methodology, reagents, suppliers, and analysis of their results Includes guidance on general approaches: formulation for in vitro assays, study monitoring, and Good Laboratory Practice (GLP) Serves as an essential reference for those new to the genetic toxicology laboratory, or anyone involved in setting up their own lab