Half Title Page.
List of Contributors.
Drug Discovery, Metabolism, And Pharmacokinetics.
2: Critical Aspects of Integrated Nonclinical Drug Development: Concepts, Strategies, and Potential Pitfalls.
3: ADME in Drug Discovery.
4: Pharmacokinetics and Toxicokinetics.
Toxicological Studies and Ind Application, and First In-Human Clinical Trial.
5: Acute, Subacute, Subchronic, and Chronic General Toxicity Testing for Preclinical Drug Development.
6: Genetic Toxicology Testing.
7: Contemporary Practices in Core Safety Pharmacology Assessments.
8: Preparation of a Preclinical Dossier to Support an Investigational New Drug (IND) Application and First-In-Human Clinical Trial.
9: Developmental and Reproductive Toxicology.
10: Immunotoxicology Assessment in Drug Developmental.
11: Juvenile Testing to Support Clinical Trials in Pediatric Population.
12: Preclinical Evaluation of Carcinogenicity Using Standard-Bred and Genetically Engineered Rodent Models.
13: Current Strategies for Abuse Liability Assessment of New Chemical Entities.
Clinical Pathology, Histopathology, and Biomarkers.
14: Clinical Pathology.
15: Best Practice in Toxicological Pathology.
16: Molecular Pathology: Applications in Nonclinical Drug Development.
17: Biomarkers in Nonclinical Drug Development.
Biostatistics, Regulatory Toxicology, and Role of Study Directors.
18: Biostatistics for Toxicologists.
19: Regulatory Toxicology.
20: Role of Study Director and Study Monitor in Drug Development Safety Studies.
Specialty Route of Administration.
21: Infusion Toxicology and Techniques.
22: Photosafety Assessment.
Nonclinical Development of Monoclonal Antibodies, Stem Cells, Oncogenic and Non-Oncogenic Drugs, Oligonucleotides, and Vaccines.
23: Preclinical Development of Monoclonal Antibodies.
24: Nonclinical Safety Assessment of Cell-Based Therapies.
25: Preclinical Development of Nononcogenic Drugs (Small and Large Molecules).
26: Preclinical Development of Oncology Drugs.
27: Preclinical Toxicology of Vaccines1.
28: Overview of the Nonclinical Development Strategies and Class-Effects of Oligonucleotide-Based Therapeutics.
Safety Evaluation of Ocular Drugs, Botanical Products, and Medicinal Devices.
29: Safety Evaluation of Ocular Drugs.
30: Nonclinical Safety Assessment of Botanical Products.
31: Biocompatibility Evaluation of Medical Devices.
Predictive Toxicology, Toxicometabolomics, Toxicogenomics, and Imaging.
32: Application of Evolving Computational and Biological Platforms for Chemical Safety Assessment.
33: Toxicometabolomics Technology and Applications.
34: Toxicogenomics in Preclinical Development.
35: Use of Imaging for Preclinical Evaluation.