Contract Research And Development Organizations Their History Selection And Utilization

Author : Shayne C. Gad,Charles B. Spainhour,David G. Serota
Publisher : Springer Nature
Page : 515 pages
File Size : 51,9 Mb
Release : 2020-07-17
Category : Medical
ISBN : 9783030430733

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Contract Research and Development Organizations-Their History, Selection, and Utilization by Shayne C. Gad,Charles B. Spainhour,David G. Serota Pdf

This volume provides a complete update of all the materials in prior volumes on the subject (including current directories to testing labs and other support establishments worldwide), while adding substantial new material on the following topics: · The history of CROs, including snapshots of CROs and a genealogy chart making clear where they came from and where they went. · Study directors and principal investigators. · The nuts and bolts of study performance. · Electronic reporting requirements – SEND and eCTD (required for NDA, BLA, ANDA, and IND submissions). · Consultants and their roles. · An expanded examination of common problems and their solutions. This book boasts complete directories to the global universe of operating labs – where they are, how to contact them, and what they do (including special capabilities). Additionally, checklists for qualifying labs and manufacturing facilities – and for auditing studies and projects at such facilities – are included. It is directed at those in industry (specifically directed at those working for companies using CRO services) but will also be of interest to scientists or administrators working in research organizations themselves. In this case, the contents of this new work are essential to the target reader because the work, regulations, and actors (CROs) have evolved and changed at a rapid pace in the 10 years since the earlier volume that the author published. Likewise, the companies using these services have come to all be almost completely dependent on outsourcing. The earlier texts remain the only source of their kind (paper or electronic) on the field and the only noncommercial guide to the global industry and this volume provides a complete update.

Author : Shayne C. Gad
Publisher : CRC Press
Page : 189 pages
File Size : 42,5 Mb
Release : 2003-07-03
Category : Medical
ISBN : 9780203634011

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The Selection and Use of Contract Research Organizations by Shayne C. Gad Pdf

Choosing the right contract research organization (CRO) can make the difference between getting a product to market quickly and cost-effectively, and wasting valuable time and money. The vast number of available CROs is increasing all the time, and all of them make impressive claims. The Selection and Use of Contract Research Organizations is your

Author : Jorge DiMartino,Gregory H. Reaman,Franklin O. Smith
Publisher : Springer Nature
Page : 184 pages
File Size : 47,6 Mb
Release : 2022-11-18
Category : Medical
ISBN : 9783031063572

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Pediatric Cancer Therapeutics Development by Jorge DiMartino,Gregory H. Reaman,Franklin O. Smith Pdf

This book provides a comprehensive overview of the scientific, medical, regulatory, and economic considerations associated with the discovery, development, and delivery of novel therapeutics for children with cancer. Co-authored by a diverse team from academic, government, and industry backgrounds, the book describes the steps in the process from the identification of a promising therapeutic target to the evaluation of drug candidates in the various phases of clinical testing and regulatory review. Throughout, special emphasis is placed on the unique biology of pediatric malignancies and the medical and social needs of children and their families. In providing a firm grounding in the drug development process, the book will be of value to all with an interest in how medicines currently used to treat pediatric cancer were made available. This includes trainees as well as established practitioners and others participating in translational and clinical research in the academic setting.

Author : Shayne C. Gad,Charles B. Spainhour
Publisher : Springer Science & Business Media
Page : 213 pages
File Size : 55,9 Mb
Release : 2011-08-04
Category : Medical
ISBN : 9781461400493

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Contract Research and Development Organizations by Shayne C. Gad,Charles B. Spainhour Pdf

The last 10 years have seen a seismic shift in therapeutic product development and testing. In both the pharmaceutical (both small and large molecule) and medical device sectors, the vast majority of testing and evaluation of products is not performed within innovator companies, but rather has been outsourced to a growing universe of commercial organizations. The authors both have more than 30 years experience in this field, and both have worked within innovator companies, for CROs, and as consultants in the field. Contract Research and Development Organizations: Their Role in Global Product Development has been crafted by these authors to provide a how to guide for all aspects of working with CROs in selecting, working with and ensuring the best possible desirable outcome of having the R&D function, or substantial parts of it, outsourced. It uses as the exemplary case nonclinical safety assessment, biocompatibility and efficacy testing which are to be performed to select the best possible candidate compound, device or formulation and then moving the resulting regulated therapeutic medical product into and through the development process and to marketing approval. But also covered are the contract synthesis of drug substances and corresponding manufacture of biologics and manufacture of products, formulation development, clinical evaluation, regulatory and document preparation support, and use of consultants. Included in the volume are an exhaustive listing of those CROs in the (drug and device) safety evaluation sector and their contact information and capabilities, and extensive similar listing for the other types of contract service providers. Also included are guidances on how to monitor ongoing work at contract facilities and audit check lists for GLP, GMP and GCP facilities. These listings are international in scope, and a specific chapter addresses working with some of the newer international CROs.

Author : Shayne Cox Gad,Dexter W. Sullivan, Jr.
Publisher : John Wiley & Sons
Page : 996 pages
File Size : 40,7 Mb
Release : 2023-01-12
Category : Medical
ISBN : 9781119755852

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Drug Safety Evaluation by Shayne Cox Gad,Dexter W. Sullivan, Jr. Pdf

Drug Safety Evluation Comprehensive and practical guide presenting a roadmap for safety assessment as an integral part of the development of drugs and therapeutics This fourth edition of Drug Safety Evaluation maintains the central objective of presenting an all-inclusive practical guide for those who are responsible for ensuring the safety of drugs and biologics to patients, healthcare providers, those involved in the manufacture of medicinal products, and all those who need to understand how the safety of these products is evaluated and shepherding valuable candidates to market. Individual chapters address specific approaches to evaluation hazards, including problems that are encountered and their solutions. Also covered are the scientific and philosophical bases for evaluation of specific concerns (e.g., carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching the new problems that have come to face both our society and the new challenges they brought. The many changes in regulatory requirements, pharmaceutical development, technology, and the effects of Covid on our society and science have required both extensive revision to every chapter and the addition of four new chapters. Specific sample topics covered in Drug Safety Evaluation include: The drug development process and the global pharmaceutical marketplace and regulation of human pharmaceutical safety Sources of information for consideration in study and program design and in safety evaluation Electronic records, reporting and submission, screens in safety and hazard assessment, and formulations, routes, and dosage regimens Mechanisms and endpoints of drug toxicity, pilot toxicity testing in drug safety evaluation, and repeat dose toxicity Genotoxicity, QSAR tools for drug safety, toxicogenomics, nonrodent animal studies, and developmental and reproductive toxicity testing An appendix which provides an up to date guide to CROs for conducting studies Drug Safety Evaluation was written specifically for the pharmaceutical and biotechnology industries, including scientists, consultants, and academics, to show a utilitarian yet scientifically valid path to the everyday challenges of safety evaluation and the problem solving that is required in drug discovery and development.

Author : Anonim
Publisher : Unknown
Page : 502 pages
File Size : 41,9 Mb
Release : 1969
Category : Industrial engineering
ISBN : UOM:39015006088960

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Management, a Continuing Literature Survey with Indexes by Anonim Pdf

Author : United States. National Aeronautics and Space Administration
Publisher : Unknown
Page : 148 pages
File Size : 52,8 Mb
Release : 2024-06-28
Category : Electronic
ISBN : STANFORD:36105024715844

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NASA SP-7500 by United States. National Aeronautics and Space Administration Pdf

Author : Anonim
Publisher : Unknown
Page : 732 pages
File Size : 53,9 Mb
Release : 1986
Category : Industrial engineering
ISBN : IND:30000089833994

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Management by Anonim Pdf

Author : Anonim
Publisher : Unknown
Page : 1442 pages
File Size : 47,7 Mb
Release : 1984-03-20
Category : Administrative law
ISBN : UIUC:30112059138898

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Federal Register by Anonim Pdf

Author : Anonim
Publisher : Unknown
Page : 582 pages
File Size : 52,8 Mb
Release : 1983
Category : Education
ISBN : PSU:000068696955

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Resources in Education by Anonim Pdf

Serves as an index to Eric reports [microform].

Author : Anonim
Publisher : Unknown
Page : 914 pages
File Size : 42,9 Mb
Release : 1973
Category : Education
ISBN : CUB:U183048546993

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Research in Education by Anonim Pdf

Author : Anonim
Publisher : Unknown
Page : 848 pages
File Size : 44,9 Mb
Release : 1982
Category : Power resources
ISBN : RUTGERS:39030024691786

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Energy Abstracts for Policy Analysis by Anonim Pdf

Author : Jonathan Michie
Publisher : Routledge
Page : 2166 pages
File Size : 44,8 Mb
Release : 2014-02-03
Category : Social Science
ISBN : 9781135932268

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Reader's Guide to the Social Sciences by Jonathan Michie Pdf

This 2-volume work includes approximately 1,200 entries in A-Z order, critically reviewing the literature on specific topics from abortion to world systems theory. In addition, nine major entries cover each of the major disciplines (political economy; management and business; human geography; politics; sociology; law; psychology; organizational behavior) and the history and development of the social sciences in a broader sense.

Author : Stephanie W. Ahmed, DNP, FNP-BC, DPNAP,Linda C. Andrist, PhD, RN, WHNP-BC,Sheila M. Davis, DNP, ANP-BC, FAAN,Valerie J. Fuller, DNP, ACNP-BC, FNP-BC, GNP-BC
Publisher : Springer Publishing Company
Page : 296 pages
File Size : 46,9 Mb
Release : 2012-07-11
Category : Medical
ISBN : 9780826108166

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DNP Education, Practice, and Policy by Stephanie W. Ahmed, DNP, FNP-BC, DPNAP,Linda C. Andrist, PhD, RN, WHNP-BC,Sheila M. Davis, DNP, ANP-BC, FAAN,Valerie J. Fuller, DNP, ACNP-BC, FNP-BC, GNP-BC Pdf

Named a 2013 Doody's Core Title! "This is an excellent book for both students and current DNPs. The primary areas it addresses--leadership, healthcare policy, and information technology---are essential for the advanced practice nurse to function as a change agent in today's healthcare environment. The book challenges DNPs to engage in clinical practice to the full scope of their capabilities."--Score: 100, 5 Stars. Doody's Medical Reviews This is the only professional issues-oriented Doctor of Nursing Practice (DNP) text to fully integrate all eight American Association of Colleges of Nursing DNP competencies into one volume. It defines practice scholarship for the DNP role and facilitates the sound development of key leadership skills that enable DNP graduates to effectively influence politics and health care policy in order to improve patient and population health care outcomes. The text focuses on the educational requirements of DNPs engaged in the arenas of leadership, health care policy, and information technology. It covers the growth and development of the DNP role, particularly in the context of contemporary health care challenges. With a focus on the Capstone Project, the text addresses the relationship of the DNP role to ongoing scholarship. It covers three important essentials of the DNP curriculumóevidence-based practice, health information technology, and outcomes measurementóand how they can be used to transform health care in the 21st century. The textís challenging and thought-provoking content is of particular value not only to students, but also to professors who will welcome the clarity it offers to the highly complex DNP curriculum. Key Features: Simplifies the highly complex DNP curriculum and integrates DNP core competencies throughout Demonstrates the application of core competencies to practice and aggregate care Provides a well-organized supplement to all courses across the DNP curriculum Uses exemplars of students and practicing DNPs to illustrate effective implementation Offers concrete guidance for achieving a thorough understanding of how DNP graduates utilize core competencies

Author : Anonim
Publisher : Unknown
Page : 568 pages
File Size : 41,9 Mb
Release : 1980
Category : Hydrology
ISBN : UOM:39015034724487

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Selected Water Resources Abstracts by Anonim Pdf