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Genotoxicity and Carcinogenicity Testing of Pharmaceuticals
This book provides an overview of the nonclinical testing strategies that are used to asses and de-risk the genotoxicity and carcinogenicity properties of human pharmaceuticals. It includes a review of relevant ICH guidelines, numerous case studies where follow-up studies were conducted to further investigate positive findings, and practical considerations for the use of alternative and emerging tests. With contributions from recognized experts in the pharmaceutical industry and health authorities, this volume presents a balanced view on the interpretation and application of genotoxicity and carcinogenicity regulatory guidances. Genotoxicity and Carcinogenicity Testing of Pharmaceuticals is a valuable resource for scientists, regulators, and consultants that are engaged in the conduct, reporting, and review of nonclinical studies. This book will also help academicians better understand and appreciate the complexity of the regulations and breadth of toxicology research that are necessary to support the development and marketing of new drugs.
Reducing Animal Use in Carcinogenicity Testing
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.
Biomaterials Science
Completely revised and expanded update of the best-selling classic text/reference which defined an entire subject field.
Reviews in Environmental Health (1998)
The "man who invented the future," Verne created the prototype for modern science fiction. His prophetic 1870 adventure novel, featuring a bizarre underwater craft commanded by the mysterious Captain Nemo, predated the submarine. The crowning achievement of Verne's literary career, the book influenced H. G. Wells and later generations of writers.
Carcinogenicity
Offers comprehensive coverage of currently available cancer predictors, the most recent research on carcinogenicity, and the design and interpretation of carcinogenicity experiments. Presents mouse, rat, and human carcinogenicity data for the liver, kidney, breast, cervix, prostate, hematopoietic system, colon, skin, urinary bladder, mouth, stomach, thyroid, and pancreas.
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.
