Drug Safety Evaluation Methods and Protocols

• Other Authors: Gautier, Jean-Charles (Editor)
• Format: Book
• Language: English
• Published: New York, NY Humana Press 2017
• Edition: Second Edition
• Series: Methods in molecular biology (Clifton, N.J.) v. 1641; Springer protocols (Series) |x
• Subjects: Drugs > Laboratory manuals > Toxicology; Drugs > Laboratory manuals > Testing; Drug Evaluation, Preclinical > methods; Drug-Related Side Effects and Adverse Reactions; Toxicity Tests > methods
• Online Access: Click Here to View Status and Holdings.
• Physical Description: xi, 427 pages illustrations, some colour 26 cm.
• Bibliography: Includes bibliographical references and index
• ISBN: 9781493971701
• ISSN: 1064-3745

This second edition provides up-to-date chapters and new chapters focusing on the most recent advances in the field of drug safety evaluation. Divided into seven parts, chapters detail specific aspects related to the experimental design of preclinical studies conducted to support the safety of pediatric and combination drugs, necropsy and histopathology evaluation, mass spectrometry imaging, genetic toxicology protocols including the Pig-a mutation assay, safety pharmacology methods such as automatization of patch-clamp procedures, target safety assessment for investigative toxicology, screening assays for developmental toxicology, and methods to characterize novel translational safety biomarkers like microRNAs. Written in the highly successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting to avoid known pitfalls. Authoritative and practical, Drug Safety Evaluation: Methods and Protocols, Second Edition aims to ensure successful results in the further study of this vital field.