Current Topics in Nonclinical Drug Development: Volume 2

The second volume in the "CURRENT TOPICS IN NONCLINICAL DRUG DEVELOPMENT SERIES" explores critical issues and current topics in nonclinical drug development, covering individual topics and strategies from compound characterization to drug registration. Recent advances in technologies and regulatory guidance are discussed, including AI, carcinogenicity testing, drug-drug interactions, idiosyncratic drug reactions, cardiovascular risks, 3D cell cultures, and small molecule-antibody complexes. The book is a valuable resource for toxicologists, toxicologic pathologists, consultants, regulators, study directors, and nonclinical scientists, aiding in resolving day-to-day issues and providing a reference for academicians and graduate students.

Format: Hardback
Length: 471 pages
Publication date: 09 November 2023
Publisher: Taylor & Francis Ltd

The second installment in the CURRENT TOPICS IN NONCLINICAL DRUG DEVELOPMENT SERIES delves into the critical aspects and emerging topics in nonclinical drug development. This comprehensive volume encompasses a range of individual topics and strategies, spanning from compound characterization to drug registration. Authored by a diverse group of experts in the field, it explores recent and rapid advancements in technologies, as well as the corresponding changes in regulatory guidance.

Among the selected topics are:

Evolution of Artificial Intelligence (AI) technologies and their profound impact on toxicologic pathology.

Current approaches to carcinogenicity testing, including in vitro and in vivo methodologies.

Predicting drug-drug interactions, a crucial aspect of drug development to ensure safety and efficacy.

A comprehensive understanding of idiosyncratic drug reactions, their mechanisms, and their management.

Assessing cardiovascular risks beyond the QT interval, recognizing the importance of non-QT effects in drug safety.

Utilization of 3D cell cultures in toxicology and ADME (absorption, distribution, metabolism, and excretion) assessments.

Development of small molecule-antibody complexes, a promising approach in drug discovery.

Differentiating adverse from non-adverse findings in nonclinical studies, a critical aspect of risk assessment.

Current Topics in Nonclinical Drug Development: Volume 2 serves as a valuable resource for toxicologists, toxicologic pathologists, consultants, regulators, study directors, and nonclinical scientists. It provides practical insights and strategies to address the day-to-day challenges encountered in drug development, aiding in the formulation of effective solutions. Moreover, the book serves as a valuable reference for academicians and graduate students pursuing research in nonclinical drug development.

Weight: 1060g
Dimension: 234 x 156 (mm)
ISBN-13: 9780367466688