Handbook Of Data Recording Maintenance And Management For The Biomedical Sciences

Author : Shayne C. Gad,Stephanie M. Taulbee
Publisher : CRC Press
Page : 98 pages
File Size : 46,8 Mb
Release : 1996-07-08
Category : Science
ISBN : 0849301378

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Handbook of Data Recording, Maintenance, and Management for the Biomedical Sciences by Shayne C. Gad,Stephanie M. Taulbee Pdf

The Handbook of Data Recording, Maintenance, and Management for the Biomedical Sciences explains how to maintain a scientific log that will withstand peer, federal, and other reviewing agencies' scrutiny. This is a timely publication as the maintenance of a log becomes an increasingly more important issue. It covers data monitoring, recording and maintenance; quality assurance; and printed forms, and the laws and regulations that impact their design and use.

Author : Diane Schmidt,Elisabeth B. Davis
Publisher : CRC Press
Page : 484 pages
File Size : 45,7 Mb
Release : 2001-12-06
Category : Language Arts & Disciplines
ISBN : 9780824741716

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Using The Biological Literature by Diane Schmidt,Elisabeth B. Davis Pdf

"Provides an in-depth review of current print and electronic tools for research in numerous disciplines of biology, including dictionaries and encyclopedias, method guides, handbooks, on-line directories, and periodicals. Directs readers to an associated Web page that maintains the URLs and annotations of all major Inernet resources discussed in th

Author : Wanda M. Haschek,Colin G. Rousseaux,Matthew A. Wallig
Publisher : Academic Press
Page : 3054 pages
File Size : 52,9 Mb
Release : 2013-05-01
Category : Medical
ISBN : 9780124157651

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Haschek and Rousseaux's Handbook of Toxicologic Pathology by Wanda M. Haschek,Colin G. Rousseaux,Matthew A. Wallig Pdf

Haschek and Rousseaux's Handbook of Toxicologic Pathology is a key reference on the integration of structure and functional changes in tissues associated with the response to pharmaceuticals, chemicals and biologics. The 3e has been expanded by a full volume, and covers aspects of safety assessment not discussed in the 2e. Completely revised with many new chapters, it remains the most authoritative reference on toxicologic pathology for scientists and researchers studying and making decisions on drugs, biologics, medical devices and other chemicals, including agrochemicals and environmental contaminants. New topics include safety assessment, the drug life cycle, risk assessment, communication and management, carcinogenicity assessment, pharmacology and pharmacokinetics, biomarkers in toxicologic pathology, quality assurance, peer review, agrochemicals, nanotechnology, food and toxicologic pathology, the environment and toxicologic pathology and more. Provides new chapters and in-depth discussion of timely topics in the area of toxicologic pathology and broadens the scope of the audience to include toxicologists and pathologists working in a variety of settings Offers high-quality and trusted content in a multi-contributed work written by leading international authorities in all areas of toxicologic pathology Features hundreds of full color images in both the print and electronic versions of the book to highlight difficult concepts with clear illustrations

Author : Arthur D. Chapman
Publisher : GBIF
Page : 61 pages
File Size : 42,5 Mb
Release : 2005
Category : Biodiversity
ISBN : 9788792020031

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Principles of Data Quality by Arthur D. Chapman Pdf

Author : P.J. Bert Hakkinen,Gerald Kennedy,Frederick W. Stoss
Publisher : Elsevier
Page : 953 pages
File Size : 55,7 Mb
Release : 2000-01-10
Category : Medical
ISBN : 9780080534664

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Information Resources in Toxicology by P.J. Bert Hakkinen,Gerald Kennedy,Frederick W. Stoss Pdf

Information Resources in Toxicology, Third Edition is a sourcebook for anyone who needs to know where to find toxicology information. It provides an up-to-date selective guide to a large variety of sources--books, journals, organizations, audiovisuals, internet and electronic sources, and more. For the Third Edition, the editors have selected, organized, and updated the most relevant information available. New information on grants and other funding opportunities, physical hazards, patent literature, and technical reports have also been added.This comprehensive, time-saving tool is ideal for toxicologists, pharmacologists, drug companies, testing labs, libraries, poison control centers, physicians, legal and regulatory professionals, and chemists. Serves as an all-in-one resource for toxicology information New edition includes information on publishers, grants and other funding opportunities, physical hazards, patent literature, and technical reports Updated to include the latest internet and electronic sources, e-mail addresses, etc. Provides valuable data about the new fields that have emerged within toxicological research; namely, the biochemical, cellular, molecular, and genetic aspects

Author : Shayne C. Gad
Publisher : CRC Press
Page : 708 pages
File Size : 42,7 Mb
Release : 1999-07-02
Category : Medical
ISBN : 1420000551

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Product Safety Evaluation Handbook, Second Edition by Shayne C. Gad Pdf

"Provides comprehensive, single-source coverage of the latest toxicity testing requirements and methods for personal care products, industrial and agricultural chemicals, and consumer goods. Second Edition, contains a new chapter on toxicokinetic testing and modeling, offers the latest solutions to common problems in testing and risk assessment, supplies an updated bibliography and more than 1300 references-over 100 new to this edition, and more."

Author : Cédric Grueau,Robert Laurini,Lemonia Ragia
Publisher : Springer Nature
Page : 177 pages
File Size : 50,9 Mb
Release : 2021-05-17
Category : Computers
ISBN : 9783030763749

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Geographical Information Systems Theory, Applications and Management by Cédric Grueau,Robert Laurini,Lemonia Ragia Pdf

This book constitutes selected, revised and extended papers of the 6th International Conference on Geographical Information Systems Theory, Applications and Management, GISTAM 2020, held in Prague, Czech Republic, May 2020. Due to the COVID-19 pandemic the conference was held online. The 9 revised full papers presented were carefully reviewed and selected from 62 submissions. The papers are centered on urban and regional planning; water information systems; geospatial information and technologies; spatio-temporal database management; decision support systems; energy information systems; GPS and location detection.

Author : Shayne C. Gad,Charles B. Spainhour,David G. Serota
Publisher : Springer Nature
Page : 515 pages
File Size : 40,5 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,Charles B. Spainhour
Publisher : Springer Science & Business Media
Page : 213 pages
File Size : 48,9 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 C. Gad
Publisher : CRC Press
Page : 189 pages
File Size : 46,6 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 : Shayne C. Gad
Publisher : CRC Press
Page : 424 pages
File Size : 54,5 Mb
Release : 2001-07-19
Category : Medical
ISBN : 142002518X

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Regulatory Toxicology, Second Edition by Shayne C. Gad Pdf

This practical resource provides toxicologists and scientists with essential information on the regulations that govern their jobs and products. Regulatory Toxicology also covers the scientific and historical underpinnings of those regulations. Each chapter provides a grounding in the historical events that led to the development of original legislation and major subsequent changes in legislation. The major administrative divisions for regulatory agencies and their main missions and responsibilities are also detailed, as are the basic filing units or documents the agencies require of individuals to meet goals. This second edition is updated to reflect new developments in the field.

Author : Shayne Cox Gad
Publisher : John Wiley & Sons
Page : 918 pages
File Size : 43,7 Mb
Release : 2016-11-18
Category : Medical
ISBN : 9781119097402

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Drug Safety Evaluation by Shayne Cox Gad Pdf

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

Author : Shayne Cox Gad,Samantha Gad-McDonald
Publisher : CRC Press
Page : 606 pages
File Size : 43,7 Mb
Release : 2015-12-01
Category : Medical
ISBN : 9781482248388

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Biomaterials, Medical Devices, and Combination Products by Shayne Cox Gad,Samantha Gad-McDonald Pdf

Biomaterials, Medical Devices, and Combination Products is a single-volume guide for those responsible for-or concerned with-developing and ensuring patient safety in the use and manufacture of medical devices.The book provides a clear presentation of the global regulatory requirements and challenges in evaluating the biocompatibility and clinical

Author : Shayne C. Gad,Marian G. McCord
Publisher : CRC Press
Page : 314 pages
File Size : 50,7 Mb
Release : 2008-10-20
Category : Medical
ISBN : 9781439809488

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Safety Evaluation in the Development of Medical Devices and Combination Products by Shayne C. Gad,Marian G. McCord Pdf

Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety in the use and manufacture of medical devices. It has been extensively updated to reflect significant advances, incorporating combination products and helpful case examples of current real-l

Author : Wanda M. Haschek-Hock,Colin G. Rousseaux,Matthew A. Wallig,Brad Bolon
Publisher : Academic Press
Page : 1154 pages
File Size : 48,6 Mb
Release : 2021-10-20
Category : Medical
ISBN : 9780128218297

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Haschek and Rousseaux's Handbook of Toxicologic Pathology, Volume 1: Principles and Practice of Toxicologic Pathology by Wanda M. Haschek-Hock,Colin G. Rousseaux,Matthew A. Wallig,Brad Bolon Pdf

Haschek and Rousseaux's Handbook of Toxicologic Pathology, recognized by many as the most authoritative single source of information in the field of toxicologic pathology, has been extensively updated to continue its comprehensive and timely coverage. The fourth edition has been expanded to four separate volumes due to an explosion of information in this field requiring new and updated chapters. Completely revised with a number of new chapters, Volume 1, "Principles and the Practice of Toxicologic Pathology," covers the practice of toxicologic pathology in three parts: Principles of Toxicologic Pathology, Methods in Toxicologic Pathology, and the Practice of Toxicologic Pathology. Other volumes in this work round out the depth and breadth of coverage.Volume 2 encompasses "Toxicologic Pathology in Safety Assessment" and "Environmental Toxicologic Pathology". These two sections cover the application of toxicologic pathology in developing specific product classes, principles of data interpretation for safety assessment, and toxicologic pathology of major classes of environmental toxicants. Volumes 3 and 4 provide deep and broad treatment of "Target Organ Toxicity", emphasizing the comparative and correlative aspects of normal biology and toxicant-induced dysfunction, principal methods for toxicologic pathology evaluation, and major mechanisms of toxicity. These volumes comprise the most authoritative reference on toxicologic pathology for pathologists, toxicologists, research scientists, and regulators studying and making decisions on drugs, biologics, medical devices, and other chemicals, including agrochemicals and environmental contaminants. Each volume is being published separately. Provides new chapters on digital pathology, juvenile pathology, in vitro/in vivo correlation, big data technologies and in-depth discussion of timely topics in the area of toxicologic pathology Offers high-quality and trusted content in a multi-contributed work written by leading international authorities in all areas of toxicologic pathology Features hundreds of full-color images in both the print and electronic versions of the book to highlight difficult concepts with clear illustrations