Preclinical Development Handbook: ADME and Biopharmaceutical PropertiesISBN: 978-0-470-24847-8
Hardcover
1352 pages
April 2008
Other Available Formats: E-book
|
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