A Comprehensive Guide to Toxicology in Preclinical Drug Development

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. Chapters written by world-renowned contributors who are experts in their fields Includes the latest research in preclinical drug testing and international guidelines Covers preclinical toxicology in small molecules and biologics in one single source Content: Front Matter , Page iii Copyright , Page iv Dedication , Page v Foreword , Page xiii Contributors , Pages xv-xvi Chapter 1 - Introduction , Pages 1-2 Chapter 2 - ADME in Drug Discovery , Pages 3-30 Chapter 3 - Pharmacokinetics and Toxicokinetics , Pages 31-68 Chapter 4 - Development of Preclinical Formulations for Toxicology Studies , Pages 69-86 Chapter 5 - Acute, Sub-Acute, Sub-Chronic and Chronic General Toxicity Testing for Preclinical Drug Development , Pages 87-105 Chapter 6 - Contemporary Practices in Core Safety Pharmacology Assessments , Pages 107-140 Chapter 7 - Genetic Toxicology Testing , Pages 141-166 Chapter 8 - Clinical Pathology , Pages 167-211 Chapter 9 - Best Practice in Toxicological Pathology , Pages 213-236 Chapter 10 - Molecular Pathology: Applications in Nonclinical Drug Development , Pages 237-276 Chapter 11 - Infusion Toxicology and Techniques , Pages 277-307 Chapter 12 - The Preparation of a Preclinical Dossier to Support an Investigational New Drug (IND) Application and First-in-Human Clinical Trial , Pages 309-334 Chapter 13 - Developmental and Reproductive Toxicology , Pages 335-364 Chapter 14 - Immunotoxicology Assessment in Drug Development , Pages 365-381 Chapter 15 - Juvenile Toxicity Testing to Support Clinical Trials in the Pediatric Population , Pages 383-394 Chapter 16 - Photosafety: Current Methods and Future Direction , Pages 395-422 Chapter 17 - Preclinical Evaluation of Carcinogenicity using the Rodent Two-Year Bioassay , Pages 423-436 Chapter 18 - Carcinogenicity Evaluations using Genetically Engineered Animals , Pages 437-449 Chapter 19 - Current Strategies for Abuse Liability Assessment of New Chemical Entities , Pages 451-478 Chapter 20 - Impact of Product Attributes on Preclinical Safety Evaluation , Pages 479-488 Chapter 21 - Preclinical Development of Monoclonal Antibodies , Pages 489-516 Chapter 22 - Preclinical Development of Non-Oncogenic Drugs (Small and Large Molecules) , Pages 517-542 Chapter 23 - Preclinical Development of Oncology Drugs , Pages 543-565 Chapter 24 - Safety Evaluation of Ocular Drugs , Pages 567-617 Chapter 25 - Preclinical Toxicology of Vaccines , Pages 619-645 Chapter 26 - Overview of the Nonclinical Development Strategies and Class-Effects of Oligonucleotide-Based Therapeutics , Pages 647-664 Chapter 27 - Nonclinical Safety Assessment of Botanical Products , Pages 665-675 Chapter 28 - Regulatory Toxicology , Pages 677-711 Chapter 29 - New Drug Regulation and Approval in China , Pages 713-723 Chapter 30 - Biostatistics for Toxicologists , Pages 725-746 Chapter 31 - Role of Study Director and Study Monitor in Drug Development , Pages 747-757 Chapter 32 - Use of Imaging for Preclinical Evaluation , Pages 759-775 Chapter 33 - Predictive Toxicology: Biological Assay Platforms , Pages 777-806 Chapter 34 - Toxicometabolomics: Technology and Applications , Pages 807-825 Chapter 35 - Toxicogenomics in Preclinical Development , Pages 827-854 Chapter 36 - Practical Aspects of Developing In-Licensed Pharmaceutical Products: The Virtual Development Paradigm , Pages 855-865 Index , Pages 867-885

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.

• Chapters written by world-renowned contributors who are experts in their fields
• Includes the latest research in preclinical drug testing and international guidelines
• Covers preclinical toxicology in small molecules and biologics in one single source

A Comprehensive Guide to Toxicology in Preclinical Drug Development is designed for toxicologists who need a thorough understanding of the drug development process. This multi-contributed reference will provide a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics --