Preclinical development handbook ADME and biopharmaceutical properties [[electronic resource] /] / [edited by] Shayne Cox Gad

• Record Nr.: UNINA9910458943503321
• Pubbl/distr/stampa: Hoboken, N.J., : Wiley-Interscience, c2008
• ISBN: 1-281-23741-8; 9786611237417; 0-470-24903-X; 0-470-24902-1
• Descrizione fisica: 1 online resource (1347 p.)
• Collana: Pharmaceutical Development Series ; ; v.3
• Altri autori (Persone): GadShayne C. <1948->
• Disciplina: 615.1901; 615.7; 615/.7
• Soggetti: Pharmacokinetics; Drug development; Electronic books.
• Lingua di pubblicazione: Inglese
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Note generali: Description based upon print version of record.
• Nota di bibliografia: Includes bibliographical references and index.
• Nota di contenuto: 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 Administration; 10 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; 23 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; 33 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
• Sommario/riassunto: 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, 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