A Comprehensive Guide to Toxicology in Preclinical Drug Development

A Comprehensive Guide to Toxicology in Preclinical Drug Development

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Description

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.
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Product details

  • Paperback | 1024 pages
  • 216 x 276mm
  • Academic Press Inc
  • San Diego, United States
  • English
  • Approx. 300 illustrations; Illustrations, unspecified
  • 0128100532
  • 9780128100530
  • 1,796,247

Table of contents

Introduction
ADME in Drug Discovery
Pharmacokinetics and Toxicokinetics
Development of Preclinical Formulations for Toxicology Studies
Acute, Sub-Acute, Sub-Chronic and Chronic General Toxicity Testing for Preclinical Drug Development
Contemporary Practices in Core Safety Pharmacology Assessments
Genetic Toxicology Testing
Clinical Pathology
Best Practice in Toxicologic Pathology
Molecular Pathology: Applications in Nonclinical Drug Development
Infusion Toxicology and Techniques
The Preparation of a Preclinical Dossier to Support an Investigational New Drug (IND) Application and First-in-Human Clinical Trials
Developmental and Reproductive Toxicology
Immunotoxicology Assessment in Drug Development
Juvenile Toxicity Testing to Support Clinical Trials in the Pediatric Population
Photosafety: Current Methods and Future Direction
Preclinical Evaluation of Carcinogenicity using the Rodent Two-Year Bioassay
Carcinogenicity Evaluations using Genetically Engineered Animals
Current Strategies for Abuse Liability Assessment of New Chemical Entities
Impact of Product Attributes on Preclinical Safety Evaluation
Preclinical Development of Monoclonal Antibodies
Preclinical Development of Non-Oncogenic Drugs (Small and Large Molecules)
Preclinical Development of Oncology Drugs
Safety Evaluation of Ocular Drugs
Preclinical toxicology of Vaccines
Overview of the Nonclinical Development Strategies and Class-Effects of Oligonucleotide-Based Therapeutics
Nonclinical Safety Assessment of Botanical Drugs
Regulatory Toxicology
New Drug Regulation and Approval in China
Biostatistics for Toxicologists
Role of Study Director and Study Monitor in Drug Development
Use of Imaging for Preclinical Evaluation
Predictive Toxicology: Biological Assay Platforms
Toxicometabolomics: Technology and Applications
Toxicogenomics in Preclinical Development
Practical Aspects of Developing In-Licensed Pharmaceutical Products: The Virtual Development Paradigm
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Review quote

"...a wide-ranging overview of various areas of toxicology, covering a relatively novel selection of subject areas that are not normally seen together...This book is reasonably priced...it would be a good addition to a toxicologist's bookshelf or an Institution's library."--BTS Newsletter, Summer 2013 "This book will be an important addition to the libraries of researchers in toxicology and related disciplines, and with its comprehensive approach to preclinical toxicology, it will be a key reference for any medical professional interested in drug development."--Journal of the American Veterinary Medicine Association, December 15, 2013 "The first new toxicology text to address both small and large molecules within the drug development process with contributions from leading scientists from around the globe is now available. Published by Elsevier, A Comprehensive Guide to Toxicology in Preclinical Drug Development covers the entire process of preclinical drug testing, beginning with investigative toxicology and includes the evaluation of the toxicologic and pharmacologic effects of new chemical entities, as well as in vitro and in vivo laboratory animal testing."--Drug Discovery Online, March 29, 2013 "Incorporating real-life case studies and examples, the book is a practical guide that outlines day-to-day activities and experiences in preclinical toxicology...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."--VeterinaryWorld.org, April 17, 2013
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About Ali S. Faqi

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.
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