Oecd Series On Testing And Assessment Guidance Document 116 On The Conduct And Design Of Chronic Toxicity And Carcinogenicity Studies Supporting Test Guidelines 451 452 And 453 Second Edition
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OECD Series on Testing and Assessment Guidance Document 116 on the Conduct and Design of Chronic Toxicity and Carcinogenicity Studies, Supporting Test Guidelines 451, 452 and 453 Second edition
This guidance provides additional information on the conduct of studies performed using Test Guidelines 451, 452 and Test Guideline 453.
Haschek and Rousseaux's Handbook of Toxicologic Pathology, Volume 2: Safety Assessment and Toxicologic Pathology
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 five 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 2: Toxicologic Pathology in Safety Assessment is an essential part of the most authoritative reference on toxicologic pathology principles and techniques for assessing product safety and human risk. Volume 2 describes the integration of product-induced structural and functional changes in tissues and the interpretation of their biological implications. Completely revised with many new chapters, Volume 2 of the Fourth Edition covers product safety assessment from many angles including current and emerging issues in toxicologic pathology for many product classes. Volume 2 of the Handbook of Toxicologic Pathology is a key resource for pathologists, toxicologists, research scientists, and regulators who use toxicologic pathology methods to study and make decisions on product safety. - Previous chapters on such topics as drug discovery and development, toxicity and carcinogenicity testing, report preparation, and risk assessment and communication have undergone extensive revision that includes in-depth discussion of new developments in the field - New chapters consider fundamental attributes for additional product classes including protein therapeutics, nucleic acid pharmaceutical agents, gene therapy and gene editing, stem cell and other cell therapies, vaccines, agricultural and bulk chemicals, and assigning adversity - Chapters dealing with product-specific practices address pathology and regulatory issues - Chapters offer high-quality and up-to-date content in a trusted work written by the collaborative efforts of many leading international subject matter experts - Hundreds of full-color images and diagrams are featured in both the print and electronic versions of this book to illustrate classic examples and highlight difficult concepts
Reducing Animal Use in Carcinogenicity Testing
Author: Joseph Manuppello
language: en
Publisher: Frontiers Media SA
Release Date: 2024-12-31
Carcinogenicity to rats and mice is evaluated for substances to which humans are exposed, including pharmaceuticals, agrochemicals, and industrial chemicals. For pharmaceuticals, recent efforts to reduce animal use in long-term studies include an addendum to the International Council for Harmonisation (ICH) guideline S1B(R1) that prioritizes short-term studies in transgenic mice and recommends assessing the weight of evidence available to first determine whether a long-term study in rats would add value. For other sectors, an expert group of the Organisation for Economic Cooperation and Development (OECD) is developing an Integrated Approach to the Testing and Assessment (IATA) of non-genotoxic carcinogens based on common hallmarks of cancers and on key characteristics of carcinogens. Within current regulations, animal use could be reduced by evaluating toxicokinetics in main study animals with microsampling methods, by including only one negative control group, and by genotyping transgenic mice instead of using positive control groups in each study.