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Full Description
The second volume in the CURRENT TOPICS IN NONCLINICAL DRUG DEVELOPMENT SERIES explores the critical issues and current topics in nonclinical drug development. This second volume covers individual topics and strategies in drug development from compound characterization to drug registration. Written by a variety of experts in the field, recent and rapid advances in technologies and associated changes in regulatory guidance are discussed.
Select topics include:
Evolution of Artificial Intelligence (AI) technologies and the impact on toxicologic pathology.
Current approaches to carcinogenicity testing.
Predicting drug-drug interactions.
Current understanding of idiosyncratic drug reaction.
Assessing cardiovascular risks beyond QT interval.
Use of 3D cell cultures in toxicology and ADME.
Development of small molecule-antibody complexes.
Differentiating adverse from non-adverse findings in nonclinical studies.
Current Topics in Nonclinical Drug Development: Volume 2 will aid toxicologists, toxicologic pathologists, consultants, regulators, study directors, and nonclinical scientists dealing with day-to-day issues encountered in drug development and assist in formulating strategies for resolution of these issues. In addition, the book will be a valuable reference for academicians and graduate students pursuing research related to nonclinical drug development.
Contents
1. Introduction and History of Digital Toxicologic Pathology 2. Carcinogenicity Testing of Human Pharmaceuticals 3. Differentiating Adverse and Non-adverse Findings in Nonclinical Studies 4. Current Understanding of Idiosyncratic Drug Reactions 5. Three-Dimensional Cell Culture Models in Toxicology and ADME 6. Assessing Cardiovascular Risk Beyond the hERG Channel and the QT Interval 7. Fundamentals of Drug-Drug Interactions 8. Development of Small Molecule-Antibody Complexes
