Drug Safety Evaluation
Methods and Protocols
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Beschreibung
Non-clinical drug safety evaluation, the assessment of the safety profile of therapeutic agents through the conduct of laboratory studies in in vitro systems and in animals, is an essential step in the progress of new pharmaceuticals heading toward the ultimate goal of clinical trials and, eventually, approval. In Drug Safety Evaluation: Methods and Protocols, expert researchers detail a compendium of analytical technologies with a focus on clarity and applicability in real life laboratory practice. These meticulous contributions feature key topics such as acute to chronic general toxicity studies, histopathology studies, reproductive toxicity studies, genotoxicity studies, safety pharmacology studies, investigative toxicity studies, and safety biomarker studies. As a volume in the highly successful Methods in Molecular Biology™ series, chapters include brief introductions to their respective subjects, lists of the necessary materials, step-by-step, readily reproducible protocols, and tips on troubleshooting and avoiding known pitfalls.
Comprehensive and authoritative, Drug Safety Evaluation: Methods and Protocols serves as an ideal guide to this field, helpful to pharmaceutical scientists, toxicologists, biochemists, and molecular biologists as well as scientists from all other disciplines who wish to translate these thorough methods into their own work.
Non-clinical drug safety evaluation, the assessment of the safety profile of therapeutic agents through the conduct of laboratory studies in in vitro systems and in animals, is an essential step in the progress of new pharmaceuticals heading toward the ultimate goal of clinical trials and, eventually, approval. In Drug Safety Evaluation: Methods and Protocols, expert researchers detail a compendium of analytical technologies with a focus on clarity and applicability in real life laboratory practice. These meticulous contributions feature key topics such as acute to chronic general toxicity studies, histopathology studies, reproductive toxicity studies, genotoxicity studies, safety pharmacology studies, investigative toxicity studies, and safety biomarker studies. As a volume in the highly successful Methods in Molecular Biology™ series, chapters include brief introductions to their respective subjects, lists of the necessary materials, step-by-step, readily reproducible protocols, and tips on troubleshooting and avoiding known pitfalls.
Comprehensive and authoritative, Drug Safety Evaluation: Methods and Protocols serves as an ideal guide to this field, helpful to pharmaceutical scientists, toxicologists, biochemists, and molecular biologists as well as scientists from all other disciplines who wish to translate these thorough methods into their own work.
Features a compendium of analytical technologies, including some review chapters, with a focus on clarity and applicability in real life laboratory practice Contains methods and techiques easily translated to a myriad of scientific disciplines Presents key tips from the experts on the best way to conduct these techniques succesfully Includes supplementary material: sn.pub/extras
Autor*in
Jean-Charles Gautier
Themen in »Drug Safety Evaluation«
Carcinogenicity Chemical protein adducts Developmental toxicity Experimental design General toxicity studies Genotoxicity Novel safety biomarkers Reproductive toxicology Safety pharmacology Screening assays Therapeutic agents
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From the reviews:
“Describes in detail the standard, analytical methodologies that are used to evaluate the safety of a new compound or a particular compound’s use in a vulnerable patient population. … This is intended to serve as a resource for a variety of basic science researchers, as well as anyone interested in the methods used in evaluating drug safety in a preclinical setting. … This a very technical overview of the standard laboratory procedures and protocols used in the preclinical evaluation of drug safety.” (Rachel R. Chennault, Doody’s Review Service, April, 2011)()