LEADER 04221nam 2200661Ia 450 001 9910784842603321 005 20200520144314.0 010 $a1-281-23742-6 010 $a9786611237424 010 $a0-470-24905-6 010 $a0-470-24904-8 035 $a(CKB)1000000000404577 035 $a(EBL)333798 035 $a(OCoLC)476138565 035 $a(SSID)ssj0000226314 035 $a(PQKBManifestationID)11185936 035 $a(PQKBTitleCode)TC0000226314 035 $a(PQKBWorkID)10233396 035 $a(PQKB)11612085 035 $a(MiAaPQ)EBC333798 035 $a(Au-PeEL)EBL333798 035 $a(CaPaEBR)ebr10226745 035 $a(CaONFJC)MIL123742 035 $a(PPN)243349165 035 $a(EXLCZ)991000000000404577 100 $a20080125d2008 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 00$aPreclinical development handbook$iToxicology$b[electronic resource] /$f[edited by] Shayne Cox Gad 210 $aHoboken, NJ $cWiley-Interscience$dc2008 215 $a1 online resource (1075 p.) 225 1 $aPharmaceutical Development Series ;$vv.4 300 $aDescription based upon print version of record. 311 $a0-470-24846-7 320 $aIncludes bibliographical references and index. 327 $aPRECLINICAL DEVELOPMENT HANDBOOK Toxicology; CONTRIBUTORS; CONTENTS; Preface; 1 Preclinical Drug Development Planning; 2 Use of Project Teams in Preclinical Development; 3 Relationship between Animal Models and Clinical Research: Using Mucositis as a Practical Example; 4 Bacterial Mutation Assay; 5 In Vitro Mammalian Cell Mutation Assays; 6 In Vitro Mammalian Cytogenetic Tests; 7 In Vivo Genotoxicity Assays; 8 Repeat Dose Toxicity Studies; 9 Irritation and Local Tissue Tolerance Studies in Pharmacetical Safety Assessment; 10 Safety Assessment Studies: Immunotoxicity 327 $a11 Immunotoxicity Testing: ICH Guideline S8 and Related Aspects12 Reproductive and Developmental Toxicology; 13 Carcinogenicity Studies; 14 Toxicokinetics: An Integral Component of Preclinical Toxicity Studies; 15 In Vitro Toxicokinetics and Dynamics: Modeling and Interpretation of Toxicity Data; 16 Toxicologic Pathology; 17 Secondary Pharmacodynamic Studies and In Vitro Pharmacological Profiling; 18 Current Practices in Safety Pharmacology; 19 Safety Assessment of Biotechnology-Derived Therapeutics; 20 Preclinical Development of Protein Pharmaceuticals: An Overview 327 $a21 The Pharmacogenomics of Personalized Medicine22 Genomics; 23 Proteomics; 24 Toxicogenomics in Preclinical Development; 25 Toxicoproteomics: Preclinical Studies; 26 Regulatory Considerations; 27 Regulatory Issues in Preclinical Safety Studies (U.S. FDA); 28 Selection and Utilization of CROs for Safety Assessment; 29 Auditing and Inspecting Preclinical Research and Compliance with Good Laboratory Practice (GLP); 30 Drug Impurities and Degradants and Their Safety Qualification; 31 Bridging Studies in Preclinical Pharmaceutical Safety Assessment; Index 330 $aA clear, straightforward resource to guide you through preclinical drug developmentFollowing this book's step-by-step guidance, you can successfully initiate and complete critical phases of preclinical drug development. The book serves as a basic,comprehensive reference to prioritizing and optimizing leads, toxicity, pharmacogenomics, modeling, and regulations. This single definitive, easy-to-use resource discusses all the issues that need consideration and provides detailed instructions for current methods and techniques.Each chapter was written by one or more leading experts 410 0$aPharmaceutical Development Series 606 $aDrugs$xToxicology$vHandbooks, manuals, etc 606 $aDrugs$xToxicity testing$vHandbooks, manuals, etc 615 0$aDrugs$xToxicology 615 0$aDrugs$xToxicity testing 676 $a615.7 676 $a615.7040724 676 $a615.9 701 $aGad$b Shayne C.$f1948-$096171 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910784842603321 996 $aPreclinical development handbook$93681700 997 $aUNINA