Preclinical Development Handbook

A clear, straightforward resource to guide you through preclinical drug development Following 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 toxicoproteomics Each 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.

A clear, straightforward resource to guide you through preclinicaldrug developmentFollowing this book's step-by-step guidance, you can successfullyinitiate and complete critical phases of preclinical drugdevelopment. The book serves as a basic,comprehensive reference toprioritizing and optimizing leads, toxicity, pharmacogenomicsmodeling, and regulations. This single definitive, easy-to-useresource discusses all the issues that need consideration andprovides detailed instructions for current methods andtechniques.Each chapter was written by one or more leading experts in thefield. These authors, representing the many disciplines involved inpreclinical toxicology screening and testing, give you the toolsneeded to apply an effective multidisciplinary approach. Theeditor, with more than thirty years' experience working withpharmaceutical and biotechnology companies, carefully reviewed allthe chapters to ensure that each one is thorough, accurate, andclear.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 beencountered and their solutions. The authors also set forth thelimitations of various methods and techniques used in determiningthe safety and efficacy of a drug during the preclinicalstage.This is a hands-on guide for pharmaceutical scientists involved inpreclinical testing,enabling them to perform and documentpreclinical safety tests to meet all FDA requirements beforeclinical trials may begin.

Preface.1 Preclinical Drug Development Planning (Nirmala BhogalRobert 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. GibsonJoanne 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. JulianPreston).7 In Vivo Genotoxicity Assays (Andreas HartmannKrista L. Dobo, and Hans-Jörg Martus).8 Repeat Dose Toxicity Studies (Shayne Cox Gad).9 Irritation and Local Tissue Tolerance Studies in PharmaceticalS afety Assessment (Shayne Cox Gad).10 Safety Assessment Studies: Immunotoxicity (JacquesDescotes).11 Immunotoxicity Testing: ICH Guideline S8 and Related Aspects(Hans-Gerd Pauels and John Taylor).12 Reproductive and Developmental Toxicology (Ronald D. Hoodand Robert M. Parker).13 Carcinogenicity Studies (Shayne Cox Gad).14 Toxicokinetics: An Integral Component of Preclinical ToxicityS tudies (Sonu Sundd Singh).15 In Vitro Toxicokinetics and Dynamics: Modeling andInterpretation of Toxicity Data (Arie Bruinink).16 Toxicologic Pathology (Paul B. Tchounwou and José A.Centeno).17 Secondary Pharmacodynamic Studies and In VitroPharmacological Profiling (Duncan Armstrong, Jacques MigeonMichael G. Rolf, Joanne Bowes, Mark Crawford, and Jean-PierreValentin).18 Current Practices in Safety Pharmacology (Alan S. BassPeter K. S. Siegl, Gary A. Gintant, Dennis J. Murphy, and RogerPorsolt).19 Safety Assessment of Biotechnology-Derived T herapeutics(Mary Ellen Cosenza).20 Preclinical Development of Protein Pharmaceuticals: An Overview (Dipankar Das and Mavanur R. Suresh).21 The Pharmacogenomics of Personalized Medicine (Ronald E.Reid).22 Genomics (Dimitri Semizarov and Eric A. G.Blomme).23 Proteomics (Juan Casado and J. Ignacio Casal).24 Toxicogenomics in Preclinical Development (Eric A. G.Blomme, Dimitri Semizarov, and Jeffrey F. Waring).25 Toxicoproteomics: Preclinical Studies (B. Alex Merrick andMaribel E. Bruno).26 Regulatory Considerations (Evan B. Siegel and Duane B.Lakings).27 Regulatory Issues in Preclinical Safety Studies (U.S. FDA)(Kenneth L. Hastings and William J. Brock).28 Selection and Utilization of CROs for Safety Assessment(Joanne R. Kopplin and Ward R. Richter).29 Auditing and Inspecting Preclinical Research and Compliancewith Good Laboratory Practice (GLP) (N. J. Dent).30 Drug Impurities and Degradants and Their Safety Qualification(Robin C. Guy).31 Bridging Studies in Preclinical Pharmaceutical SafetyAssessment (Shayne Cox Gad).Index.