LEADER 04574nam 2200661Ia 450 001 9910784504203321 005 20230721030620.0 010 $a1-281-23741-8 010 $a9786611237417 010 $a0-470-24903-X 010 $a0-470-24902-1 035 $a(CKB)1000000000401090 035 $a(EBL)333797 035 $a(OCoLC)476138555 035 $a(SSID)ssj0000226315 035 $a(PQKBManifestationID)11235959 035 $a(PQKBTitleCode)TC0000226315 035 $a(PQKBWorkID)10257897 035 $a(PQKB)10882296 035 $a(MiAaPQ)EBC333797 035 $a(Au-PeEL)EBL333797 035 $a(CaPaEBR)ebr10226748 035 $a(CaONFJC)MIL123741 035 $a(EXLCZ)991000000000401090 100 $a20080125d2008 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $2rdacontent 182 $2rdamedia 183 $2rdacarrier 200 00$aPreclinical development handbook$iADME and biopharmaceutical properties$b[electronic resource] /$f[edited by] Shayne Cox Gad 210 $aHoboken, N.J. $cWiley-Interscience$dc2008 215 $a1 online resource (1347 p.) 225 1 $aPharmaceutical Development Series ;$vv.3 300 $aDescription based upon print version of record. 311 $a0-470-24847-5 320 $aIncludes bibliographical references and index. 327 $aPRECLINICAL DEVELOPMENT HANDBOOK ADME and Biopharmaceutical Properties; CONTRIBUTORS; CONTENTS; Preface; 1 Modeling and Informatics in Drug Design; 2 Computer Techniques: Identifying Similarities Between Small Molecules; 3 Protein-Protein Interactions; 4 Method Development for Preclinical Bioanalytical Support; 5 Analytical Chemistry Methods: Developments and Validation; 6 Chemical and Physical Characterizations of Potential New Chemical Entity; 7 Permeability Assessment; 8 How and Where Are Drugs Absorbed?; 9 Absorption of Drugs after Oral Administration 327 $a10 Distribution: Movement of Drugs through the Body11 The Blood-Brain Barrier and Its Effect on Absorption and Distribution; 12 Transporter Interactions in the ADME Pathway of Drugs; 13 Accumulation of Drugs in Tissues; 14 Salt and Cocrystal Form Selection; 15 Dissolution; 16 Stability: Physical and Chemical; 17 Dosage Formulation; 18 Cytochrome P450 Enzymes; 19 Metabolism Kinetics; 20 Drug Clearance; 21 In Vitro Metabolism in Preclinical Drug Development; 22 Utilization of In Vitro Cytochrome P450 Inhibition Data for Projecting Clinical Drug-Drug Interactions 327 $a23 In Vivo Metabolism in Preclinical Drug Development24 In Vitro Evaluation of Metabolic Drug-Drug Interactions: Scientific Concepts and Practical Considerations; 25 Mechanisms and Consequences of Drug-Drug Interactions; 26 Species Comparison of Metabolism in Microsomes and Hepatocytes; 27 Metabolite Profiling and Structural Identification; 28 Linkage between Toxicology of Drugs and Metabolism; 29 Allometric Scaling; 30 Interrelationship between Pharmacokinetics and Metabolism; 31 Experimental Design Considerations in Pharmacokinetic Studies; 32 Bioavailability and Bioequivalence Studies 327 $a33 Mass Balance Studies34 Pharmacodynamics; 35 Physiologically Based Pharmacokinetic Modeling; 36 Mathematical Modeling as a New Approach for Improving the Efficacy/Toxicity Profile of Drugs: The Thrombocytopenia Case Study; 37 Regulatory Requirements for INDs/FIH (First in Human) Studies; 38 Data Analysis; Index 330 $aA clear, straightforward resource to guide you through preclinical drug developmentFollowing this book's step-by-step guidance, you can successfully initiate and complete critical phases of preclinical drug development. The book serves as a basic, comprehensive reference to prioritizing and optimizing leads, dose formulation, ADME, pharmacokinetics, modeling, and regulations. This authoritative, easy-to-use resource covers all the issues that need to be considered and provides detailed instructions for current methods and techniques.Each chapter is written by one or more leadin 410 0$aPharmaceutical Development Series 606 $aPharmacokinetics$vHandbooks, manuals, etc 606 $aDrug development$vHandbooks, manuals, etc 615 0$aPharmacokinetics 615 0$aDrug development 676 $a615.1901 676 $a615.7 676 $a615/.7 701 $aGad$b Shayne C.$f1948-$096171 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910784504203321 996 $aPreclinical development handbook$93681700 997 $aUNINA