A Comprehensive Guide to Toxicology in Nonclinical Drug Development 3rd Edition
Capture the essential science and regulatory insight behind modern preclinical safety with A Comprehensive Guide to Toxicology in Nonclinical Drug Development, 3rd Edition by Ali S. Faqi. This authoritative resource brings clarity to complex toxicology concepts that drive successful nonclinical programs across the pharmaceutical and biotechnology industries.
Built for toxicologists, safety assessment scientists, regulatory professionals, CRO teams, and advanced students, this updated third edition delivers practical guidance on study design, species selection, dose translation, biomarker integration, and interpretation of toxicologic findings. It synthesizes contemporary regulatory expectations from global agencies such as FDA, EMA and ICH, while addressing advances in in vitro, in silico and alternative-model approaches that reduce animal use and accelerate translational safety assessment.
You’ll find clear explanations of key areas—safety pharmacology, genotoxicity, reproductive and developmental toxicology, immunotoxicology, and risk-benefit evaluation—presented with an emphasis on real-world application in nonclinical drug development. Richly updated content supports decision-making across discovery through IND/CTA submission, helping teams anticipate regulatory questions and streamline development timelines.
Whether you’re building a safety strategy for a small-molecule, biologic, or novel modality, this book is a go-to reference that enhances confidence and competence in global drug-development programs. Add A Comprehensive Guide to Toxicology in Nonclinical Drug Development, 3rd Edition to your professional library today to stay current with best practices and regulatory expectations—order now to support safer, more effective therapeutic advancement.
Note: eBooks do not include supplementary materials such as CDs, access codes, etc.


