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.
Table of Contents
1. Introduction 2. ADME in Drug Discovery 3. Pharmacokinetics and Toxicokinetics 4. Development of Preclinical Formulations for Toxicology Studies 5. Acute, Sub-Acute, Sub-Chronic and Chronic General Toxicity Testing for Preclinical Drug Development 6. Contemporary Practices in Core Safety Pharmacology Assessments 7. Genetic Toxicology Testing 8. Clinical Pathology 9. Best Practice in Toxicologic Pathology 10. Molecular Pathology: Applications in Nonclinical Drug Development 11. Infusion Toxicology and Techniques 12. The Preparation of a Preclinical Dossier to Support an Investigational New Drug (IND) Application and First-in-Human Clinical Trials 13. Developmental and Reproductive Toxicology 14. Immunotoxicology Assessment in Drug Development 15. Juvenile Toxicity Testing to Support Clinical Trials in the Pediatric Population 16. Photosafety: Current Methods and Future Direction 17. Preclinical Evaluation of Carcinogenicity using the Rodent Two-Year Bioassay 18. Carcinogenicity Evaluations using Genetically Engineered Animals 19. Current Strategies for Abuse Liability Assessment of New Chemical Entities 20. Impact of Product Attributes on Preclinical Safety Evaluation 21. Preclinical Development of Monoclonal Antibodies 22. Preclinical Development of Non-Oncogenic Drugs (Small and Large Molecules) 23. Preclinical Development of Oncology Drugs 24. Safety Evaluation of Ocular Drugs 25. Preclinical toxicology of Vaccines 26. Overview of the Nonclinical Development Strategies and Class-Effects of Oligonucleotide-Based Therapeutics 27. Nonclinical Safety Assessment of Botanical Drugs 28. Regulatory Toxicology 29. New Drug Regulation and Approval in China 30. Biostatistics for Toxicologists 31. Role of Study Director and Study Monitor in Drug Development 32. Use of Imaging for Preclinical Evaluation 33. Predictive Toxicology: Biological Assay Platforms 34. Toxicometabolomics: Technology and Applications 35. Toxicogenomics in Preclinical Development 36. Practical Aspects of Developing In-Licensed Pharmaceutical Products: The Virtual Development Paradigm
Authors
Ali S. Faqi ASF Scientific Solutions, Portage, MI, USA.Ali Said Faqi, DVM, PhD, DABT, ATS, is a Senior Director of Developmental and Reproductive Toxicology, a Senior Principal Scientist at MPI Research and an Adjunct Associate Professor at Wayne State University, School of Medicine, Department of OBGYN in Detroit, MI. He received his Ph.D. from the University of Leipzig in Germany in 1995 and D.V.M. from Somali National University. Dr. Faqi earned a diploma of specialization in Experimental Pharmacology from the University of Milan in Italy.
He was a postdoctoral fellow at the Institute of Clinical Pharmacology and Toxicology at the Free University of Berlin-Germany from 1996 till 1998. He worked as a Research Associate at Morehouse School of Medicine in Atlanta, Georgia and at Thomas Jefferson University in Philadelphia, Pennsylvania. Before joining MPI Research, Dr. Faqi was a Senior Scientist at Allergan Pharmaceuticals in Irvine, California and a Research Toxicologist at IIT Research Institute in Chicago, Illinois. He is a Diplomate of American Board of Toxicology (D.A.B.T.) and a Fellow of Academy of Toxicological Sciences (A.T.S.). Dr. Faqi is a member of the Editorial Board of Reproductive Toxicology Journal and ISRN Toxicology. He served as a Board of Scientific Counselors (BOSC) Computational Toxicology at the United States Environmental Protection Agency (US EPA) from September, 2009-September, 2010. He is also a member of Scientific Advisory Board of the Alzheimer's Art Quilt Initiative (AAQI).
Dr. Ali Faqi is ad-hoc scientific reviewer for the scientific journals (Regulatory Pharmacology and Toxicology, Toxicology Journal, System Biology in Reproductive Medicine, Pesticide Biochemistry and Physiology, PLoS ONE and Birth Defects Research Part B: Developmental & Reproductive Toxicology). He is a Visiting Professor at the University of Palermo, Italy. In 2009, Dr. Faqi was a guest speaker at King Fahd Medical Research Center in King Abdiaziz University, Jeddah (Saudi Arabia) where he lectured on Preclinical Toxicology.
He is a past chairman of the membership committee of the Teratology Society and a past President of Michigan Society of Toxicology. Currently, he is the chairman of the Education Committee of the Teratology Society (2012-2013) and the Vice President of Toxicologists of African Origin (2012-2013). He has published over 100 technical and scientific papers and authored and co-authored 7 book chapters.
