Drug Safety Evaluation: Methods and Protocols

Description

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. Front Matter....Pages i-xiii Front Matter....Pages 1-1 Front Matter....Pages 3-16 Front Matter....Pages 17-35 Front Matter....Pages 37-37 Front Matter....Pages 39-67 Front Matter....Pages 69-82 Front Matter....Pages 83-96 Front Matter....Pages 97-112 Front Matter....Pages 113-113 Back Matter....Pages 115-136 ....Pages 137-147