A Comprehensive Guide to Toxicology in Preclinical Drug Development is a resource for toxicologists in industry and regulatory settings, as well as directors working in contract resource organizations, who need a thorough understanding of the drug development process. Incorporating real-life case studies and examples, the book is a practical guide that outlines day-to-day activities and experiences in preclinical toxicology. This multi-contributed reference provides a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics. The book discusses discovery toxicology and the international guidelines for safety evaluation, and presents traditional and nontraditional toxicology models. Chapters cover development of vaccines, oncology drugs, botanic drugs, monoclonal antibodies, and more, as well as study development and personnel, the role of imaging in preclinical evaluation, and supporting materials for IND applications. By incorporating the latest research in this area and featuring practical scenarios, this reference is a complete and actionable guide to all aspects of preclinical drug testing.
IntroductionADME in Drug DiscoveryPharmacokinetics and ToxicokineticsDevelopment of Preclinical Formulations for Toxicology StudiesAcute, Sub-Acute, Sub-Chronic and Chronic General Toxicity Testing for Preclinical Drug Development Contemporary Practices in Core Safety Pharmacology AssessmentsGenetic Toxicology TestingClinical PathologyBest Practice in Toxicologic PathologyMolecular Pathology: Applications in Nonclinical Drug DevelopmentInfusion Toxicology and TechniquesThe Preparation of a Preclinical Dossier to Support an Investigational New Drug (IND) Application and First-in-Human Clinical TrialsDevelopmental and Reproductive ToxicologyImmunotoxicology Assessment in Drug DevelopmentJuvenile Toxicity Testing to Support Clinical Trials in the Pediatric PopulationPhotosafety: Current Methods and Future DirectionPreclinical Evaluation of Carcinogenicity using the Rodent Two-Year BioassayCarcinogenicity Evaluations using Genetically Engineered AnimalsCurrent Strategies for Abuse Liability Assessment of New Chemical EntitiesImpact of Product Attributes on Preclinical Safety EvaluationPreclinical Development of Monoclonal AntibodiesPreclinical Development of Non-Oncogenic Drugs (Small and Large Molecules)Preclinical Development of Oncology DrugsSafety Evaluation of Ocular DrugsPreclinical toxicology of VaccinesOverview of the Nonclinical Development Strategies and Class-Effects of Oligonucleotide-Based TherapeuticsNonclinical Safety Assessment of Botanical DrugsRegulatory ToxicologyNew Drug Regulation and Approval in ChinaBiostatistics for ToxicologistsRole of Study Director and Study Monitor in Drug DevelopmentUse of Imaging for Preclinical EvaluationPredictive Toxicology: Biological Assay PlatformsToxicometabolomics: Technology and ApplicationsToxicogenomics in Preclinical DevelopmentPractical Aspects of Developing In-Licensed Pharmaceutical Products: The Virtual Development Paradigm