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Informationen zum Autor SHAYNE COX GAD, PhD, DABT, ATS, is the Principal of Gad Consulting Services. Dr. Gad has more than thirty years of experience as a toxicologist, statistical consultant, manager, and general consultant on research and development in the chemical, consumer product, contract testing, biotechnology, medical device, and pharmaceutical industries. He is the author of twenty-nine books and numerous papers, presentations, and other publications. Klappentext A clear, straightforward resource to guide you through preclinical drug developmentFollowing this book's step-by-step guidance, you can successfully initiate and complete critical phases of preclinical drug development. The book serves as a basic,comprehensive reference to prioritizing and optimizing leads, toxicity, pharmacogenomics, modeling, and regulations. This single definitive, easy-to-use resource discusses all the issues that need consideration and provides detailed instructions for current methods and techniques.Each chapter was written by one or more leading experts in the field. These authors, representing the many disciplines involved in preclinical toxicology screening and testing, give you the tools needed to apply an effective multidisciplinary approach. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.Among the key topics covered are:*In vitro mammalian cytogenetics tests*Phototoxicity*Carcinogenicity studies*The pharmacogenomics of personalized medicine*Bridging studies*Toxicogenomics and toxicoproteomicsEach chapter offers a full exploration of problems that may be encountered and their solutions. The authors also set forth the limitations of various methods and techniques used in determining the safety and efficacy of a drug during the preclinical stage.This is a hands-on guide for pharmaceutical scientists involved in preclinical testing,enabling them to perform and document preclinical safety tests to meet all FDA requirements before clinical trials may begin. Zusammenfassung This book provides drug safety and toxicology scientists with practical guidance for testing and determining the effectiveness and safety of a new drug candidate. It authoritatively covers the important topics within toxicity testing, pharmacogenomics, and regulations for the preclinical safety testing of drug candidates. Inhaltsverzeichnis Preface. 1 Preclinical Drug Development Planning ( Nirmala Bhogal, Robert Combes, and Michael Balls ). 2 Use of Project Teams in Preclinical Development ( Dorothy M. K. Keefe, Joanne M. Bowen, and Rachel J. Gibson ). 3 Relationship between Animal Models and Clinical Research: Using Mucositis as a Practical E xample ( Rachel J. Gibson, Joanne M. Bowen, and Dorothy M. K. Keefe ). 4 Bacterial Mutation Assay ( Premkumar Kumpati ). 5 In Vitro Mammalian Cell Mutation Assays ( C. Anita H. Bigger, Martha M. Moore, and Robert H. Heflich ). 6 In Vitro Mammalian Cytogenetic T ests ( R. Julian Preston ). 7 In Vivo Genotoxicity Assays ( Andreas Hartmann, Krista L. Dobo, and Hans-Jörg Martus ). 8 Repeat Dose Toxicity Studies ( Shayne Cox Gad ). 9 Irritation and Local Tissue Tolerance Studies in Pharmacetical S afety Assessment ( Shayne Cox Gad ). 10 Safety Assessment Studies: Immunotoxicity ( Jacques Descotes ). 11 Immunotoxicity Testing: ICH Guideline S8 and Related Aspects ( Hans-Gerd Pauels and John Taylor ). 12 Reproductive and Developmental Toxicology ( Ronald D. Hood and Robert M. Parker ). 13 Carcinogenicity Studies ( Shayne Cox Gad ). 14 Toxicokinetics: An Integral Component of Preclinical Toxicity S tudies ( Sonu Sundd Singh ).<...
