A comprehensive guide to toxicology in nonclinical drug development
This book is designed to provide a complete understanding of all aspects of nonclinical toxicology in the development of small molecules and biologics. This updated edition has been reorganized and expanded to include important topics such as stem cells in nonclinical toxicology, inhalation and derm...
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| Format: | Book |
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Boston, Massachusetts :
Elsevier ,
c2016
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| Edition: | 2nd ed |
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Table of Contents:
- 1. Drug discovery, metabolism, and pharmacokinetics
- 2. Toxicological studies and IND application, and first in-human clinical trial
- 3. Clinical pathology, histopathology, and biomarkers
- 4. Biostatistics, regulatory toxicology, and role of study directors
- 5. Specialty route of administration
- 6. Nonclinical development of monoclonal antibodies, stem cells, oncogenic and non-oncogenic drugs, oligonucleotides, and vaccines
- 6. Safety evaluation of ocular drugs, botanical products, and medicinal devices
- 7. Predictive toxicology, toxicometabolomics, toxicogenomics, and imaging