Nonclinical Study Contracting and Monitoring

Nonclinical Study Contracting and Monitoring
Author: William F. Salminen,Joe M. Fowler,James Greenhaw
Publsiher: Academic Press
Total Pages: 262
Release: 2012-12-31
ISBN 10: 0123978319
ISBN 13: 9780123978318
Language: EN, FR, DE, ES & NL

Nonclinical Study Contracting and Monitoring Book Review:

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.

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
Publsiher: John Wiley & Sons
Total Pages: 560
Release: 2014-05-02
ISBN 10: 1118874080
ISBN 13: 9781118874080
Language: EN, FR, DE, ES & NL

The Role of the Study Director in Nonclinical Studies Book Review:

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

A Comprehensive Guide to Toxicology in Preclinical Drug Development

A Comprehensive Guide to Toxicology in Preclinical Drug Development
Author: Ali S. Faqi
Publsiher: Academic Press
Total Pages: 885
Release: 2012-11-16
ISBN 10: 0123878152
ISBN 13: 9780123878151
Language: EN, FR, DE, ES & NL

A Comprehensive Guide to Toxicology in Preclinical Drug Development Book Review:

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 and biologics. The book discusses discovery toxicology and the international guidelines for safety evaluation, and presents traditional and nontraditional toxicology models. Chapters cover development of vaccines, oncology drugs, botanic drugs, monoclonal antibodies, and more, as well as study development and personnel, the role of imaging in preclinical evaluation, and supporting materials for IND applications. By incorporating the latest research in this area and featuring practical scenarios, this reference is a complete and actionable guide to all aspects of preclinical drug testing. Chapters written by world-renowned contributors who are experts in their fields Includes the latest research in preclinical drug testing and international guidelines Covers preclinical toxicology in small molecules and biologics in one single source

Responsible Research

Responsible Research
Author: Institute of Medicine,Committee on Assessing the System for Protecting Human Research Participants
Publsiher: National Academies Press
Total Pages: 312
Release: 2003-02-06
ISBN 10: 0309084881
ISBN 13: 9780309084888
Language: EN, FR, DE, ES & NL

Responsible Research Book Review:

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 to the system, and Vigilant maintenance of HRPPP performance. Issues addressed in the book include the need for in-depth, complimentary reviews of science, ethics, and conflict of interest reviews; desired qualifications for investigators and reviewers; the process of informed consent; federal and institutional oversight; and the role of accreditation. Recommendations for areas of key interest include suggestions for legislative approaches, compensation for research-related injury, and the refocusing of the mission of institutional review boards. Responsible Research will be important to anyone interested in the issues that are relevant to the practice of using human subjects as research participants, but especially so to policy makers, research administrators, investigators, and research sponsors â€" but also including volunteers who may agree to serve as research participants.

Basic outlines on medical device law and regulation

Basic outlines on medical device law and regulation
Author: Food and Drug Law Institute (U.S.)
Publsiher: Unknown
Total Pages: 490
Release: 1997
ISBN 10:
ISBN 13: STANFORD:36105061865601
Language: EN, FR, DE, ES & NL

Basic outlines on medical device law and regulation Book Review:

Handbook

Handbook
Author: World Health Organization
Publsiher: World Health Organization
Total Pages: 309
Release: 2010-02-02
ISBN 10: 9241547553
ISBN 13: 9789241547550
Language: EN, FR, DE, ES & NL

Handbook Book Review:

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.

International Directory of Contract Laboratories

International Directory of Contract Laboratories
Author: Anonim
Publsiher: Marcel Dekker Incorporated
Total Pages: 171
Release: 1989
ISBN 10:
ISBN 13: UOM:39015020576784
Language: EN, FR, DE, ES & NL

International Directory of Contract Laboratories Book Review:

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
Publsiher: Unknown
Total Pages: 329
Release: 2000
ISBN 10:
ISBN 13: CORNELL:31924090554258
Language: EN, FR, DE, ES & NL

Veterinary and Human Toxicology Book Review:

Official Journal of the European Communities

Official Journal of the European Communities
Author: Anonim
Publsiher: Unknown
Total Pages: 329
Release: 1999
ISBN 10:
ISBN 13: WISC:89065546822
Language: EN, FR, DE, ES & NL

Official Journal of the European Communities Book Review:

Good Laboratory Practice Regulations Third Edition Revised and Expanded

Good Laboratory Practice Regulations  Third Edition  Revised and Expanded
Author: Sandy Weinberg
Publsiher: CRC Press
Total Pages: 264
Release: 2002-11-06
ISBN 10: 9780824745646
ISBN 13: 0824745647
Language: EN, FR, DE, ES & NL

Good Laboratory Practice Regulations Third Edition Revised and Expanded Book Review:

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 new and emerging interpretations of GLP in a variety of laboratory settings.

Drug Safety Evaluation

Drug Safety Evaluation
Author: Shayne Cox Gad
Publsiher: John Wiley & Sons
Total Pages: 918
Release: 2016-11-18
ISBN 10: 1119097401
ISBN 13: 9781119097402
Language: EN, FR, DE, ES & NL

Drug Safety Evaluation Book Review:

This practical guide presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics. Helps readers solve scientific, technical, and regulatory issues in preclinical safety assessment and early clinical drug development Explains scientific and philosophical bases for evaluation of specific concerns – including local tissue tolerance, target organ toxicity and carcinogenicity, developmental toxicity, immunogenicity, and immunotoxicity Covers the development of new small and large molecules, generics, 505(b)(2) route NDAs, and biosimilars Revises material to reflect new drug products (small synthetic, large proteins and cells, and tissues), harmonized global and national regulations, and new technologies for safety evaluation Adds almost 20% new and thoroughly updates existing content from the last edition

Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making

Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making
Author: Institute of Medicine,Roundtable on Research and Development of Drugs, Biologics, and Medical Devices
Publsiher: National Academies Press
Total Pages: 88
Release: 1999-07-27
ISBN 10: 9780309172806
ISBN 13: 0309172802
Language: EN, FR, DE, ES & NL

Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making Book Review:

In an effort to increase knowledge and understanding of the process of assuring data quality and validity in clinical trials, the IOM hosted a workshop to open a dialogue on the process to identify and discuss issues of mutual concern among industry, regulators, payers, and consumers. The presenters and panelists together developed strategies that could be used to address the issues that were identified. This IOM report of the workshop summarizes the present status and highlights possible strategies for making improvements to the education of interested and affected parties as well as facilitating future planning.

Documents

Documents
Author: Anonim
Publsiher: Unknown
Total Pages: 329
Release: 1999
ISBN 10:
ISBN 13: STANFORD:36105073272499
Language: EN, FR, DE, ES & NL

Documents Book Review:

Guide to Clinical Studies and Developing Protocols

Guide to Clinical Studies and Developing Protocols
Author: Bert Spilker
Publsiher: Unknown
Total Pages: 302
Release: 1984
ISBN 10:
ISBN 13: UOM:39015006706843
Language: EN, FR, DE, ES & NL

Guide to Clinical Studies and Developing Protocols Book Review:

Pain Management and the Opioid Epidemic

Pain Management and the Opioid Epidemic
Author: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse
Publsiher: National Academies Press
Total Pages: 482
Release: 2017-09-28
ISBN 10: 0309459575
ISBN 13: 9780309459570
Language: EN, FR, DE, ES & NL

Pain Management and the Opioid Epidemic Book Review:

Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.

Research Report

Research Report
Author: London School of Hygiene and Tropical Medicine
Publsiher: Unknown
Total Pages: 329
Release: 1995
ISBN 10:
ISBN 13: CHI:54493397
Language: EN, FR, DE, ES & NL

Research Report Book Review:

Consultants and Consulting Organizations Directory

Consultants and Consulting Organizations Directory
Author: Anonim
Publsiher: Unknown
Total Pages: 329
Release: 2006
ISBN 10: 9780787679460
ISBN 13: 0787679461
Language: EN, FR, DE, ES & NL

Consultants and Consulting Organizations Directory Book Review:

Nonclinical Assessment of Abuse Potential for New Pharmaceuticals

Nonclinical Assessment of Abuse Potential for New Pharmaceuticals
Author: Carrie Markgraf,Thomas Hudzik,David Compton
Publsiher: Academic Press
Total Pages: 320
Release: 2015-07-14
ISBN 10: 0124202160
ISBN 13: 9780124202160
Language: EN, FR, DE, ES & NL

Nonclinical Assessment of Abuse Potential for New Pharmaceuticals Book Review:

Nonclinical Assessment of Abuse Potential for New Pharmaceuticals offers a complete reference on the current international regulatory guidelines and details best practice methodology for the three standard animal models used to evaluate abuse potential: physical dependence, self-administration and drug discrimination. This book also includes chapters on alternative models and examples of when you should use these alternatives. Case histories are provided at the end of the book to show how the data generated from the animal models play a pivitol role in the submission package for a new drug. By incorporating all of this information into one book, Nonclinical Assessment of Abuse Potential for New Pharmaceuticals is your single resource for everything you need to know to understand and implement the assessment of abuse liability. Provides a consolidated overview of the complex regulatory landscape Offers best practice methodology for conducting animal studies, including selection of doses and positive control agents that will help you improve your own abuse potential studies Includes real-life examples to illustrate how nonclinical data fit into the submission strategy

GEN Guide to Biotechnology Companies

GEN Guide to Biotechnology Companies
Author: Anonim
Publsiher: Unknown
Total Pages: 329
Release: 1998
ISBN 10:
ISBN 13: WISC:89099266991
Language: EN, FR, DE, ES & NL

GEN Guide to Biotechnology Companies Book Review:

Data Monitoring Committees in Clinical Trials

Data Monitoring Committees in Clinical Trials
Author: Susan S. Ellenberg,Thomas R. Fleming,David L. DeMets
Publsiher: Wiley
Total Pages: 496
Release: 2019-04-01
ISBN 10: 1119512654
ISBN 13: 9781119512653
Language: EN, FR, DE, ES & NL

Data Monitoring Committees in Clinical Trials Book Review:

­The authoritative guide for Data Monitoring Committees—fully revised and updated The number of clinical trials sponsored by government agencies and pharmaceutical companies has grown in recent years, prompting an increased need for interim monitoring of data on safety and efficacy. Data Monitoring Committees (DMCs) are an essential component of many clinical trials, safeguarding trial participants and protecting the credibility and validity of the study. Data Monitoring Committees in Clinical Trials: A Practical Perspective, 2nd Edition offers practical advice for those managing and conducting clinical trials and serving on Data Monitoring Committees, providing a practical overview of the establishment, purpose, and responsibilities of these committees. Examination of topics such as the composition and independence of DMCs, statistical, philosophical and ethical considerations, and determining when a DMC is needed, presents readers with a comprehensive foundational knowledge of clinical trial oversight. Providing recent examples to illustrate DMC principles, this fully-updated guide reflects current developments and practices in clinical trial oversight and offers expanded coverage of emerging issues and challenges in the field. This new second edition covers the most current information on DMC policies, issues in monitoring trials using new designs, and recent trial publications relevant to DMC decision-making. • Presents practical advice for those managing and conducting clinical trials and serving on Data Monitoring Committees • Illustrates the types of challenging issues Data Monitoring Committees face in practical situations • Provides updated and expanded coverage of topics including regulatory and funding agency guidelines and trial designs and their associated demands and limitations • Includes a new chapter addressing legal issues that affect DMC members and discusses general litigation concerns relevant to clinical research • Expands treatment of current journal publications addressing DMC issues Data Monitoring Committees in Clinical Trials: A Practical Perspective, 2nd Edition is a must-have text for anyone engaged in DMC activities as well as trial sponsors, clinical trial researchers, regulatory and bioethics professionals, and those associated with clinical trials in academic, government and industry settings.