04574nam 2200661Ia 450 991078450420332120230721030620.01-281-23741-897866112374170-470-24903-X0-470-24902-1(CKB)1000000000401090(EBL)333797(OCoLC)476138555(SSID)ssj0000226315(PQKBManifestationID)11235959(PQKBTitleCode)TC0000226315(PQKBWorkID)10257897(PQKB)10882296(MiAaPQ)EBC333797(Au-PeEL)EBL333797(CaPaEBR)ebr10226748(CaONFJC)MIL123741(EXLCZ)99100000000040109020080125d2008 uy 0engur|n|---|||||rdacontentrdamediardacarrierPreclinical development handbookADME and biopharmaceutical properties[electronic resource] /[edited by] Shayne Cox GadHoboken, N.J. Wiley-Intersciencec20081 online resource (1347 p.)Pharmaceutical Development Series ;v.3Description based upon print version of record.0-470-24847-5 Includes bibliographical references and index.PRECLINICAL 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 Administration10 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 Interactions23 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 Studies33 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; IndexA 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 leadinPharmaceutical Development SeriesPharmacokineticsHandbooks, manuals, etcDrug developmentHandbooks, manuals, etcPharmacokineticsDrug development615.1901615.7615/.7Gad Shayne C.1948-96171MiAaPQMiAaPQMiAaPQBOOK9910784504203321Preclinical development handbook3681700UNINA