CiNii 図書 - Preclinical development handbook ; ADME and biopharmaceutical properties

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, 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 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 has carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear. Among the key topics covered are: * Modeling and informatics in drug design * Bioanalytical chemistry * Absorption of drugs after oral administration * Transporter interactions in the ADME pathway of drugs * Metabolism kinetics * Mechanisms and consequences of drug-drug interactions 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 publication should be readily accessible to all 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.

Preface xv 1 Modeling and Informatics in Drug Design 1 Prasad V. Bharatam, Smriti Khanna, and Sandrea M. Francis 2 Computer Techniques: Identifying Similarities Between Small Molecules 47 Peter Meek, Guillermo Moyna, and Randy Zauhar 3 Protein-Protein Interactions 87 Kamaljit Kaur, Dipankar Das, and Mavanur R. Suresh 4 Method Development for Preclinical Bioanalytical Support 117 Masood Khan and Naidong Weng 5 Analytical Chemistry Methods: Developments and Validation 151 Izet M. Kapetanovic and Alexander V. Lyubimov 6 Chemical and Physical Characterizations of Potential New Chemical Entity 211 Adegoke Adeniji and Adeboye Adejare 7 Permeability Assessment 227 Srinivas Ganta, Puneet Sharma, and Sanjay Garg 8 How and Where Are Drugs Absorbed? 249 Marival Bermejo and Isabel Gonzalez-Alvarez 9 Absorption of Drugs after Oral Administration 281 Luis Granero and Ana Polache 10 Distribution: Movement of Drugs through the Body 323 Jayanth Panyam and Yogesh Patil 11 The Blood-Brain Barrier and Its Effect on Absorption and Distribution 353 A. G. de Boer and P. J. Gaillard 12 Transporter Interactions in the ADME Pathway of Drugs 407 Yan Zhang and Donald W. Miller 13 Accumulation of Drugs in Tissues 429 Krishnamurthy Venkatesan, Deepa Bisht, and Mohammad Owais 14 Salt and Cocrystal Form Selection 455 Ann W. Newman, Scott L. Childs, and Brett A. Cowans 15 Dissolution 483 A.K. Tiwary, Bharti Sapra, and Subheet Jain 16 Stability: Physical and Chemical 545 Eric M. Gorman, Brian E. Padden, and Eric J. Munson 17 Dosage Formulation 571 Alexander V. Lyubimov 18 Cytochrome P450 Enzymes 627 Eugene G. Hrycay and Stelvio M. Bandiera 19 Metabolism Kinetics 697 Charles W. Locuson and Timothy S. Tracy 20 Drug Clearance 715 Sree D. Panuganti and Craig K. Svensson 21 In Vitro Metabolism in Preclinical Drug Development 743 Olavi Pelkonen, Ari Tolonen, Miia Turpeinen, and Jouko Uusitalo 22 Utilization of In Vitro Cytochrome P450 Inhibition Data for Projecting Clinical Drug-Drug Interactions 775 Jane R. Kenny, Dermot F. McGinnity, Ken Grime, and Robert J. Riley 23 In Vivo Metabolism in Preclinical Drug Development 829 Sevim Rollas 24 In Vitro Evaluation of Metabolic Drug-Drug Interactions: Scientific Concepts and Practical Considerations 853 Albert P. Li 25 Mechanisms and Consequences of Drug-Drug Interactions 879 Dora Farkas, Richard I. Shader, Lisa L. von Moltke, and David J. Greenblatt 26 Species Comparison of Metabolism in Microsomes and Hepatocytes 919 Niels Krebsfaenger 27 Metabolite Profiling and Structural Identification 937 Mehran F. Moghaddam 28 Linkage between Toxicology of Drugs and Metabolism 975 Ruiwen Zhang and Elizabeth R. Rayburn 29 Allometric Scaling 1009 William L. Hayton and Teh-Min Hu 30 Interrelationship between Pharmacokinetics and Metabolism 1037 James W. Paxton 31 Experimental Design Considerations in Pharmacokinetic Studies 1059 William W. Hope, Vidmantas Petraitis, and Thomas J. Walsh 32 Bioavailability and Bioequivalence Studies 1069 Alexander V. Lyubimov and Ihor Bekersky 33 Mass Balance Studies 1103 Jan H. Beumer, Julie L. Eiseman, and Merrill J. Egorin 34 Pharmacodynamics 1133 Beom Soo Shin, Dhaval Shah, and Joseph P. Balthasar 35 Physiologically Based Pharmacokinetic Modeling 1167 Harvey J. Clewell III, Micaela B. Reddy, Thierry Lave, and Melvin E. Andersen 36 Mathematical Modeling as a New Approach for Improving the Efficacy/Toxicity Profile of Drugs: The Thrombocytopenia Case Study 1229 Zvia Agur, Moran Elishmereni, Yuri Kogan, Yuri Kheifetz, Irit Ziv, Meir Shoham, and Vladimir Vainstein 37 Regulatory Requirements for INDs/FIH (First in Human) Studies 1267 Shayne Cox Gad 38 Data Analysis 1309 Jayesh Vora and Pankaj B. Desai Index 1323

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Preclinical development handbook ; ADME and biopharmaceutical properties

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