A Comprehensive Guide to Toxicology in Nonclinical Drug Development

by Ali S. Faqi (Editor)

Overview

A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Second Edition, is a valuable reference 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 dermal toxicology, pitfalls in drug development, biomarkers in toxicology, and more.

Thoroughly updated to reflect the latest scientific advances and with increased coverage of international regulatory guidelines, this second edition is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic, and regulatory settings.

• Provides unique content that is not always covered together in one comprehensive resource, including chapters on stem cells, abuse liability, biomarkers, inhalation toxicology, biostatistics, and more
• Updated with 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 the expectations associated with working in nonclinical toxicology

Product Details

ISBN-13:	9780128036211
Publisher:	Elsevier Science
Publication date:	11/03/2016
Sold by:	Barnes & Noble
Format:	eBook
Pages:	986
File size:	165 MB
Note:	This product may take a few minutes to download.

About the Author

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.

Table of Contents

Chapter 1. Introduction

Section I. Drug Discovery, Metabolism, and Pharmacokinetics

Chapter 2. Critical Aspects of Integrated Nonclinical Drug Development: Concepts, Strategies, and Potential Pitfalls

Chapter 3. ADME in Drug Discovery

Chapter 4. Pharmacokinetics and Toxicokinetics

Section II. Toxicological Studies and Ind Application, and First In-Human Clinical Trial

Chapter 5. Acute, Subacute, Subchronic, and Chronic General Toxicity Testing for Preclinical Drug Development

Chapter 6. Genetic Toxicology Testing

Chapter 7. Contemporary Practices in Core Safety Pharmacology Assessments

Chapter 8. Preparation of a Preclinical Dossier to Support an Investigational New Drug (IND) Application and First-In-Human Clinical Trial

Chapter 9. Developmental and Reproductive Toxicology

Chapter 10. Immunotoxicology Assessment in Drug Development

Chapter 11. Juvenile Testing to Support Clinical Trials in Pediatric Population

Chapter 12. Preclinical Evaluation of Carcinogenicity Using Standard-Bred and Genetically Engineered Rodent Models

Chapter 13. Current Strategies for Abuse Liability Assessment of New Chemical Entities

Section III. Clinical Pathology, Histopathology, and Biomarkers

Chapter 14. Clinical Pathology

Chapter 15. Best Practice in Toxicological Pathology

Chapter 16. Molecular Pathology: Applications in Nonclinical Drug Development

Chapter 17. Biomarkers in Nonclinical Drug Development

Section IV. Biostatistics, Regulatory Toxicology, and Role of Study Directors

Chapter 18. Biostatistics for Toxicologists

Chapter 19. Regulatory Toxicology

Chapter 20. Role of Study Director and Study Monitor in Drug Development Safety Studies

Section V. Specialty Route of Administration

Chapter 21. Infusion Toxicology and Techniques

Chapter 22. Photosafety Assessment

Section VI. Nonclinical Development of Monoclonal Antibodies, Stem Cells, Oncogenic and Non-Oncogenic Drugs, Oligonucleotides, and Vaccines

Chapter 23. Preclinical Development of Monoclonal Antibodies

Chapter 24. Nonclinical Safety Assessment of Cell-Based Therapies

Chapter 25. Preclinical Development of Nononcogenic Drugs (Small and Large Molecules)

Chapter 26. Preclinical Development of Oncology Drugs

Chapter 27. Preclinical Toxicology of Vaccines

Chapter 28. Overview of the Nonclinical Development Strategies and Class-Effects of Oligonucleotide-Based Therapeutics

Section VII. Safety Evaluation of Ocular Drugs, Botanical Products, and Medicinal Devices

Chapter 29. Safety Evaluation of Ocular Drugs

Chapter 30. Nonclinical Safety Assessment of Botanical Products

Chapter 31. Biocompatibility Evaluation of Medical Devices

Section VIII. Predictive Toxicology, Toxicometabolomics, Toxicogenomics, and Imaging

Chapter 32. Application of Evolving Computational and Biological Platforms for Chemical Safety Assessment

Chapter 33. Toxicometabolomics: Technology and Applications

Chapter 34. Toxicogenomics in Preclinical Development

Chapter 35. Use of Imaging for Preclinical Evaluation