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Written by a variety of experts in the field, this book explores the critical issues and current topics in nonclinical drug development. It covers individual topics and strategies in drug development from compound characterization to drug registration.
List of contents
1. Introduction and History of Digital Toxicologic Pathology 2. Carcinogenicity Testing of Human Pharmaceuticals 3. Differentiating Adverse and Non-adverse Findings in Nonclinical Studies 4. Current Understanding of Idiosyncratic Drug Reactions 5. Three-Dimensional Cell Culture Models in Toxicology and ADME 6. Assessing Cardiovascular Risk Beyond the hERG Channel and the QT Interval 7. Fundamentals of Drug-Drug Interactions 8. Development of Small Molecule-Antibody Complexes
About the author
Pritam S. Sahota, PhD, studied for his Veterinary Medicine (BVSc) and Veterinary Pathology (MVSc and PhD) degrees at Punjab Agricultural University in India. He is a Diplomate of the American Board of Toxicology. After completing his PhD, he immigrated to the USA in 1976 and worked for Dawson Research Corporation in Orlando, Florida for 10 years with increasing responsibilities as Toxicologic Pathologist, Senior Toxicologic Pathologist, and Scientific Director. Since 2012, Dr. Sahota has been President of Global ToxPath LLC (Toxicologic Pathology Consultancy) located in Kennewick, WA.
Philip Bentley, PhD, is Principal Consultant at Toxicodynamix International LLC. He studied biochemistry at the University of Hull, UK, graduating with a BSc in 1970 and a PhD in 1974. He had postdoctoral fellowships at the Universities of Basel. Switzerland and Mainz, Germany. He has authored more than 80 scientific publications, has lectured in toxicology at the University of Basel for more than 30 years, and is a past President of the European Society of Biochemical Pharmacology and the Swiss Society of Toxicology.
Zbigniew W. Wojcinski, DVM, DVSc is President of Toxicology & Pathology Consulting, LLC, in Hillsborough, NC and has over 35 years’ experience in pharmaceutical drug development. Dr. Wojcinski earned his undergraduate degree (BSc) in Zoology from the University of Toronto and his DVM and DVSc (Pathology) degrees from the Ontario Veterinary College, University of Guelph. He is a certified Diplomate of the American Board of Toxicology and a Diplomate of the American College of Veterinary Pathologists.
Summary
Written by a variety of experts in the field, this book explores the critical issues and current topics in nonclinical drug development. It covers individual topics and strategies in drug development from compound characterization to drug registration.
