A Comprehensive Guide to Toxicology in Nonclinical Drug Development
- 1,020 pages
- English
- ePUB (mobile friendly)
- Available on iOS & Android
A Comprehensive Guide to Toxicology in Nonclinical Drug Development
About This Book
A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Third Edition is a valuable reference providing a complete understanding of all aspects of nonclinical toxicology in pharmaceutical research. This updated edition has been expanded and re-developed covering a wide-range of toxicological issues in small molecules and biologics. Topics include ADME in drug discovery, pharmacokinetics, toxicokinetics, formulations, and genetic toxicology testing. The book has been thoroughly updated throughout to reflect the latest scientific advances and includes new information on antiviral drugs, anti-diabetic drugs, immunotherapy, and a discussion on post-pandemic drug development challenges and opportunities. This is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic, and regulatory settings.
- Provides updated, unique content not covered in one comprehensive resource, including chapters on stem cells, antiviral drugs, anti-diabetic drugs, and immunotherapy
- Includes the latest international guidelines for nonclinical toxicology in both small and large molecules
- Incorporates practical examples in order to illustrate day-to-day activities and expectations associated with working in nonclinical toxicology
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Table of contents
- Cover image
- Title page
- Table of Contents
- Copyright
- Dedication
- Contributors
- Preface
- Section I. Drug Discovery, Metabolism, and Toxicokinetic
- Section II. Toxicological Studies and IND Application and First-In-Human Clinical Trial and Abuse Liability
- Section III. Clinical Pathology, Toxicological Pathology, Molecular Biology, and Biomarkers
- Section IV. Biostatistics, Regulatory Toxicology, and Role of Study Directors
- Section V. Specialty Route of Administration
- Section VI. Nonclinical Development of Monoclonal Antibodies, Stem Cells, Oncogenic and Non-Oncogenic Drugs, Oligonucleotides, and Vaccines
- Section VII. Nonclinical Development of Oncogenic and Nononcogenic Drugs and Oligonucleotidebased Therapies and Vaccines
- Section VIII. Safety Evaluation of Ocular Drugs, Botanical Products, and Medicinal Devices
- Section IX. Predictive Toxicology and Imaging
- Index