Description
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
Chapter
Chapter
3 - Pharmacokinetics and Toxicokinetics
pp.：
48 – 86
Chapter
4 - Development of Preclinical Formulations for Toxicology Studies
pp.：
86 – 104
Chapter
5 - Acute, Sub-Acute, Sub-Chronic and Chronic General Toxicity Testing for Preclinical Drug Development
pp.：
104 – 124
Chapter
6 - Contemporary Practices in Core Safety Pharmacology Assessments
pp.：
124 – 158
Chapter
7 - Genetic Toxicology Testing
pp.：
158 – 184
Chapter
8 - Clinical Pathology
pp.：
184 – 230
Chapter
9 - Best Practice in Toxicological Pathology
pp.：
230 – 254
Chapter
10 - Molecular Pathology: Applications in Nonclinical Drug Development
pp.：
254 – 294
Chapter
11 - Infusion Toxicology and Techniques
pp.：
294 – 326
Chapter
12 - The Preparation of a Preclinical Dossier to Support an Investigational New Drug (IND) Application and First-in ...
pp.：
326 – 352
Chapter
13 - Developmental and Reproductive Toxicology
pp.：
352 – 382
Chapter
14 - Immunotoxicology Assessment in Drug Development
pp.：
382 – 400
Chapter
15 - Juvenile Toxicity Testing to Support Clinical Trials in the Pediatric Population
pp.：
400 – 412
Chapter
16 - Photosafety: Current Methods and Future Direction
pp.：
412 – 440
Chapter
17 - Preclinical Evaluation of Carcinogenicity using the Rodent Two-Year Bioassay
pp.：
440 – 454
Chapter
18 - Carcinogenicity Evaluations using Genetically Engineered Animals
pp.：
454 – 468
Chapter
19 - Current Strategies for Abuse Liability Assessment of New Chemical Entities
pp.：
468 – 496
Chapter
20 - Impact of Product Attributes on Preclinical Safety Evaluation
pp.：
496 – 506
Chapter
21 - Preclinical Development of Monoclonal Antibodies
pp.：
506 – 534
Chapter
22 - Preclinical Development of Non-Oncogenic Drugs (Small and Large Molecules)
pp.：
534 – 560
Chapter
23 - Preclinical Development of Oncology Drugs
pp.：
560 – 584
Chapter
24 - Safety Evaluation of Ocular Drugs
pp.：
584 – 636
Chapter
25 - Preclinical Toxicology of Vaccines1
pp.：
636 – 664
Chapter
26 - Overview of the Nonclinical Development Strategies and Class-Effects of Oligonucleotide-Based Therapeutics
pp.：
664 – 682
Chapter
27 - Nonclinical Safety Assessment of Botanical Products
pp.：
682 – 694
Chapter
28 - Regulatory Toxicology
pp.：
694 – 730
Chapter
29 - New Drug Regulation and Approval in China
pp.：
730 – 742
Chapter
30 - Biostatistics for Toxicologists
pp.：
742 – 764
Chapter
31 - Role of Study Director and Study Monitor in Drug Development
pp.：
764 – 776
Chapter
32 - Use of Imaging for Preclinical Evaluation
pp.：
776 – 794
Chapter
33 - Predictive Toxicology: Biological Assay Platforms
pp.：
794 – 824
Chapter
34 - Toxicometabolomics: Technology and Applications
pp.：
824 – 844
Chapter
35 - Toxicogenomics in Preclinical Development
pp.：
844 – 872
Chapter
36 - Practical Aspects of Developing In-Licensed Pharmaceutical Products: The Virtual Development Paradigm
pp.：
872 – 884
A Comprehensive Guide to Toxicology in Preclinical Drug Development
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