A Comprehensive Guide to Toxicology in Nonclinical Drug Development 3rd Edition
A Comprehensive Guide to Toxicology in Nonclinical Drug Development (3rd Edition) is an authoritative and detailed reference for scientists, toxicologists, pharmacologists, and regulatory professionals involved in the preclinical phases of drug development. Now available at BooksHub.pk, Pakistan’s most trusted online medical and pharmaceutical bookstore, this new edition provides up-to-date insights into nonclinical safety assessment, toxicology study design, and regulatory strategies essential for successful drug approval.
Written and reviewed by leading experts in the field, this comprehensive guide explains the entire process of nonclinical evaluation—from study planning and conduct to data interpretation and risk assessment—covering all major areas of toxicology, pathology, pharmacokinetics, and safety pharmacology. The 3rd Edition includes the latest global regulatory updates from the FDA, EMA, ICH, and OECD, ensuring readers are aligned with current international standards and practices.
The book provides in-depth discussions on species selection, dose justification, study duration, biomarkers, and translational science, offering practical advice for designing studies that accurately predict human responses. It also explores emerging areas such as biologics, gene therapies, vaccines, and nanomedicines, making it highly relevant for today’s innovative drug pipelines.
Each chapter is clearly structured, providing theoretical background alongside real-world applications, case studies, and best practices for toxicological assessment. This makes the guide invaluable for pharmaceutical scientists, CRO professionals, academic researchers, and postgraduate students involved in toxicology or drug safety research.
Key Features:
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Comprehensive coverage of nonclinical toxicology for drug development.
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Updated with current FDA, EMA, and ICH guidelines and scientific advancements.
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Includes case studies, safety assessments, and regulatory strategies.
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Covers small molecules, biologics, vaccines, and gene therapy products.
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Written by experienced industry and regulatory experts.
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Essential reference for toxicologists, pharmacologists, and regulatory scientists.
