Nonclinical Study Contracting and Monitoring

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.

Produk Detail:

  • Author : William F. Salminen
  • Publisher : Academic Press
  • Pages : 262 pages
  • ISBN : 0123978319
  • Rating : 4/5 from 21 reviews
CLICK HERE TO GET THIS BOOKNonclinical Study Contracting and Monitoring

Nonclinical Study Contracting and Monitoring

Nonclinical Study Contracting and Monitoring
  • Author : William F. Salminen,Joe M. Fowler,James Greenhaw
  • Publisher : Academic Press
  • Release : 31 December 2012
GET THIS BOOKNonclinical Study Contracting and Monitoring

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

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 : 02 May 2014
GET THIS BOOKThe Role of the Study Director in Nonclinical Studies

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

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A Comprehensive Guide to Toxicology in Preclinical Drug Development
  • Author : Ali S. Faqi
  • Publisher : Academic Press
  • Release : 16 November 2012
GET THIS BOOKA Comprehensive Guide to Toxicology in Preclinical Drug Development

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 that outlines day-to-day activities and experiences in preclinical toxicology. This multi-contributed reference provides a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules

Handbook

Handbook
  • Author : World Health Organization
  • Publisher : World Health Organization
  • Release : 02 February 2010
GET THIS BOOKHandbook

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

Good Laboratory Practice Regulations, Third Edition, Revised and Expanded

Good Laboratory Practice Regulations, Third Edition, Revised and Expanded
  • Author : Sandy Weinberg
  • Publisher : CRC Press
  • Release : 06 November 2002
GET THIS BOOKGood Laboratory Practice Regulations, Third Edition, Revised and Expanded

Fully updated and revised to include the latest information since publication of the first edition in 1989, the Second Edition of this highly praised reference covers all aspects of the Food and Drug Administration's (FDA) Good Laboratory Practice (GLP) regulations and techniques for implementation. The book details specific standards and general guidelines for the management of efficient and effective research environment. A guide to the current standards and requirements of good laboratory management, the book examines essential theoretical principles for anticipating

International Directory of Contract Laboratories

International Directory of Contract Laboratories
  • Author : Anonim
  • Publisher : Marcel Dekker Incorporated
  • Release : 21 June 1989
GET THIS BOOKInternational Directory of Contract Laboratories

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.

Pharmaceutical Toxicology in Practice

Pharmaceutical Toxicology in Practice
  • Author : Alberto Lodola,Jeanne Stadler
  • Publisher : John Wiley & Sons
  • Release : 31 March 2011
GET THIS BOOKPharmaceutical Toxicology in Practice

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 conduct, types, and reporting. As such, it is a practical guide through toxicology testing and an up-to-date reference on current issues, new developments, and future directions in toxicology. Opening with

Responsible Research

Responsible Research
  • Author : Institute of Medicine,Committee on Assessing the System for Protecting Human Research Participants
  • Publisher : National Academies Press
  • Release : 06 February 2003
GET THIS BOOKResponsible Research

When 18-year-old Jesse Gelsinger died in a gene transfer study at the University of Pennsylvania, the national spotlight focused on the procedures used to ensure research participants’ safety and their capacity to safeguard the well-being of those who volunteer for research studies. Responsible Research outlines a three-pronged approach to ensure the protection of every participant through the establishment of effective Human Research Participant Protection Programs (HRPPPs). The approach includes: Improved research review processes, Recognition and integration of research participants’ contributions

Veterinary Toxicology for Australia and New Zealand

Veterinary Toxicology for Australia and New Zealand
  • Author : Rosalind Dalefield
  • Publisher : Elsevier
  • Release : 23 June 2017
GET THIS BOOKVeterinary Toxicology for Australia and New Zealand

Veterinary Toxicology for Australia and New Zealand is a reference suited to the unique challenges of veterinary practice in Australia and New Zealand. Both streamlined and thorough in its coverage of poisons and treatments for those locations, this focused approach allows readers to quickly find relevant information that is presented in a concise and logical manner that is useful to clinicians. The authors draw upon a wealth of knowledge of the particularities of toxicology in Australia and New Zealand to