Nonclinical Study Contracting and Monitoring

Written By William F. Salminen
Nonclinical Study Contracting and Monitoring
  • Publsiher : Academic Press
  • Release : 31 December 2012
  • ISBN : 0123978319
  • Pages : 262 pages
  • Rating : 4/5 from 21 reviews
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Read or download book entitled Nonclinical Study Contracting and Monitoring written by William F. Salminen which was release on 31 December 2012, this book published by Academic Press. Available in PDF, EPUB and Kindle Format. Book excerpt: Nonclinical Study Contracting and Monitoring: A Practical Guide offers a systematic and straightforward handbook for obtaining high quality preclinical Good Laboratory Practice (GLP) studies. This book is full of real-world examples, processes, procedures, useful templates, checklists and sample reports to provide readers with a better understanding of exactly what happens during all stages of a GLP study and the critical aspects of GLP study design and conduct. Designed for both the novice and experienced scientist, this book covers the GLP regulations and how they impact preclinical studies, the differences between GLP, non-GLP and peer-reviewed studies, preclinical GLP study design, laboratory selection, contracts and business ethics, how to obtain test material for the study, animal sourcing and release for study, preparation of a draft report and much more. By illustrating the overall big picture and tying it together with the individual steps, this book is an essential resource to help scientists ensure a high quality GLP study that passes both scientific and regulatory scrutiny. Includes both the "big picture" look at complex processes, such as contracting toxicology and safety studies with CROs, as well as a detailed account of each individual step. Contains several real world examples of problems in preclinical studies to provide you with an idea of the types of challenges that are routinely encountered and how this book can help you avoid these issues. Provides monitoring checklists through the book that will help you comply with each GLP requirement and maintain compliance throughout the entire process. Both entry level and experienced scientists involved in nonclinical toxicology study monitoring will benefit from the ideas, examples, discussions and strategies presented throughout this book.

Nonclinical Study Contracting and Monitoring

Nonclinical Study Contracting and Monitoring
  • Author : William F. Salminen,Joe M. Fowler,James Greenhaw
  • Publisher : Academic Press
  • Release Date : 2012-12-31
  • Total pages : 262
  • ISBN : 0123978319
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Summary : Nonclinical Study Contracting and Monitoring: A Practical Guide offers a systematic and straightforward handbook for obtaining high quality preclinical Good Laboratory Practice (GLP) studies. This book is full of real-world examples, processes, procedures, useful templates, checklists and sample reports to provide readers with a better understanding of exactly what happens ...

The Role of the Study Director in Nonclinical Studies

The Role of the Study Director in Nonclinical Studies
  • Author : William J. Brock,Barbara Mounho,Lijie Fu
  • Publisher : John Wiley & Sons
  • Release Date : 2014-05-02
  • Total pages : 560
  • ISBN : 0123978319
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Summary : 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 ...

Federal Register

Federal Register
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 1976
  • Total pages : 212
  • ISBN : 0123978319
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Summary : Download or read online Federal Register written by , published by which was released on 1976. Get Federal Register Books now! Available in PDF, ePub and Kindle....

New Drug Approval Process

New Drug Approval Process
  • Author : Richard A. Guarino,Richard Guarino
  • Publisher : CRC Press
  • Release Date : 2016-04-19
  • Total pages : 552
  • ISBN : 0123978319
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Summary : The thoroughly revised Fifth Edition of New Drug Approval Process supplies readers with the latest global changes that affect pharmaceutical product approval and influence how new products are researched and marketed.Updated chapters include:advances in international regulatory requirements, including ICH guidelines and harmonizationa step-by-step...

Basic outlines on medical device law and regulation

Basic outlines on medical device law and regulation
  • Author : Food and Drug Law Institute (U.S.)
  • Publisher : Unknown
  • Release Date : 1997
  • Total pages : 490
  • ISBN : 0123978319
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Summary : Download or read online Basic outlines on medical device law and regulation written by Food and Drug Law Institute (U.S.), published by which was released on 1997. Get Basic outlines on medical device law and regulation Books now! Available in PDF, ePub and Kindle....

International Directory of Contract Laboratories

International Directory of Contract Laboratories
  • Author : Anonim
  • Publisher : Marcel Dekker Incorporated
  • Release Date : 1989
  • Total pages : 171
  • ISBN : 0123978319
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Summary : List of toxicology laboratories that list specific tests conducted on chemicals, foods, prescription drugs, over-the-counter drugs, cosmetics, and household products. Alphabetical arrangement by names of laboratories. Each entry gives address, telephone, year founded, and tests. Contains geographical listing. Miscellaneous indexes....

Veterinary and Human Toxicology

Veterinary and Human Toxicology
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 2000
  • Total pages : 212
  • ISBN : 0123978319
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Summary : Download or read online Veterinary and Human Toxicology written by , published by which was released on 2000. Get Veterinary and Human Toxicology Books now! Available in PDF, ePub and Kindle....

Official Journal of the European Communities

Official Journal of the European Communities
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 1999
  • Total pages : 212
  • ISBN : 0123978319
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Summary : Download or read online Official Journal of the European Communities written by , published by which was released on 1999. Get Official Journal of the European Communities Books now! Available in PDF, ePub and Kindle....

Pharmaceutical Toxicology in Practice

Pharmaceutical Toxicology in Practice
  • Author : Alberto Lodola,Jeanne Stadler
  • Publisher : John Wiley & Sons
  • Release Date : 2011-03-31
  • Total pages : 280
  • ISBN : 0123978319
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Summary : This book describes, with references to key source materials, the background to, and conduct of, the principal nonclinical studies that are central to drug development. The chapters provide an understanding of the key components of the preclinical phase of drug development with a hands-on description, with core chapters addressing study ...

Food Drug Cosmetic Law Reporter

Food  Drug  Cosmetic Law Reporter
  • Author : Commerce Clearing House
  • Publisher : Unknown
  • Release Date : 2000
  • Total pages : 212
  • ISBN : 0123978319
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Summary : Download or read online Food Drug Cosmetic Law Reporter written by Commerce Clearing House, published by which was released on 2000. Get Food Drug Cosmetic Law Reporter Books now! Available in PDF, ePub and Kindle....

A Comprehensive Guide to Toxicology in Preclinical Drug Development

A Comprehensive Guide to Toxicology in Preclinical Drug Development
  • Author : Ali S. Faqi
  • Publisher : Academic Press
  • Release Date : 2012-11-16
  • Total pages : 885
  • ISBN : 0123978319
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Summary : A Comprehensive Guide to Toxicology in Preclinical Drug Development is a resource for toxicologists in industry and regulatory settings, as well as directors working in contract resource organizations, who need a thorough understanding of the drug development process. Incorporating real-life case studies and examples, the book is a practical guide ...

Documents

Documents
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 1999
  • Total pages : 212
  • ISBN : 0123978319
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Summary : Download or read online Documents written by , published by which was released on 1999. Get Documents Books now! Available in PDF, ePub and Kindle....

Guide to Clinical Studies and Developing Protocols

Guide to Clinical Studies and Developing Protocols
  • Author : Bert Spilker
  • Publisher : Unknown
  • Release Date : 1984
  • Total pages : 302
  • ISBN : 0123978319
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Summary : Download or read online Guide to Clinical Studies and Developing Protocols written by Bert Spilker, published by which was released on 1984. Get Guide to Clinical Studies and Developing Protocols Books now! Available in PDF, ePub and Kindle....

Research Report

Research Report
  • Author : London School of Hygiene and Tropical Medicine
  • Publisher : Unknown
  • Release Date : 1995
  • Total pages : 212
  • ISBN : 0123978319
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Summary : Download or read online Research Report written by London School of Hygiene and Tropical Medicine, published by which was released on 1995. Get Research Report Books now! Available in PDF, ePub and Kindle....

Consultants Consulting Organizations Directory

Consultants   Consulting Organizations Directory
  • Author : Deborah J. Baker
  • Publisher : Unknown
  • Release Date : 2004-02
  • Total pages : 212
  • ISBN : 0123978319
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Summary : Download or read online Consultants Consulting Organizations Directory written by Deborah J. Baker, published by which was released on 2004-02. Get Consultants Consulting Organizations Directory Books now! Available in PDF, ePub and Kindle....