Preclinical Development Handbook
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Preclinical Development Handbook: ADME and Biopharmaceutical Properties(3 Pharmaceutical Development Series)

Preclinical Development Handbook: ADME and Biopharmaceutical Properties(3 Pharmaceutical Development Series)


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Table of Contents:
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

About the Author :
SHAYNE COX GAD, PHD, DABT, ATS, is the Principal of Gad Consulting Services. Dr. Gad has more than thirty years of experience as a toxicologist, statistical consultant, manager, and general consultant on research and development in the chemical, consumer product, contract testing, biotechnology, medical device, and pharmaceutical industries. He is the author of thirty- four books and numerous papers, presentations, and other publications.

Review :
"A valuable source of reference and one that I'm sure will get regular use. The diversity of topics should appeal to a variety of pharmaceutical scientists." (The British Toxicology Newsletter, Winter 2008)


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Product Details
  • ISBN-13: 9780470249024
  • Publisher: John Wiley & Sons Inc
  • Publisher Imprint: Wiley-Interscience
  • Language: English
  • Series Title: 3 Pharmaceutical Development Series
  • ISBN-10: 0470249021
  • Publisher Date: 21 Mar 2008
  • Binding: Digital (delivered electronically)
  • No of Pages: 1352
  • Sub Title: ADME and Biopharmaceutical Properties


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