Author : Shayne C. Gad
Publisher : CRC Press
Page : 98 pages
File Size : 24,42 MB
Release : 1996-07-08
Category : Science
ISBN : 9780849301377
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 : Shayne Cox Gad
Publisher : John Wiley & Sons
Page : 914 pages
File Size : 37,9 MB
Release : 2016-11-07
Category : Medical
ISBN : 1119097398
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 C. Gad
Publisher : Springer Science & Business Media
Page : 213 pages
File Size : 37,42 MB
Release : 2011-08-04
Category : Medical
ISBN : 146140049X
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 : 424 pages
File Size : 12,86 MB
Release : 2001-07-19
Category : Medical
ISBN : 9781420025187
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 C. Gad
Publisher : CRC Press
Page : 189 pages
File Size : 25,75 MB
Release : 2003-07-03
Category : Medical
ISBN : 0203634012
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 Cox Gad
Publisher : CRC Press
Page : 588 pages
File Size : 12,28 MB
Release : 2015-12-01
Category : Medical
ISBN : 1482248387
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
Publisher : CRC Press
Page : 314 pages
File Size : 11,1 MB
Release : 2008-10-20
Category : Medical
ISBN : 1439809488
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 : Jean-Christophe Rufin
Publisher : W. W. Norton & Company
Page : 1092 pages
File Size : 27,51 MB
Release : 2002-08-01
Category :
ISBN : 9780393323399
The sequel to The Abyssinian finds Jean-Baptiste Poncet in Persia practicing medicine for the Shah and trying to rescue his wife and daughter from inside the walls of a city under attack. Reprint. 11,500 first printing.
Author : Wanda M. Haschek
Publisher : Academic Press
Page : 1154 pages
File Size : 38,79 MB
Release : 2021-10-20
Category : Medical
ISBN : 0128218290
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
Author : Wanda M Haschek
Publisher : Academic Press
Page : 3055 pages
File Size : 21,30 MB
Release : 2013-05-01
Category : Medical
ISBN : 0124157653
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
