Developing Solid Oral Dosage Forms. Pharmaceutical Theory And Practice

Content: 
Copyright Page, Page iv
Dedication, Page v
Foreword, Page xxxi, J. Keith Guillory
List of Contributors, Pages xxxiii-xxxiv
Chapter 1 - Solubility of Pharmaceutical Solids, Pages 1,3-24, Venkatramana M. Rao, Ritesh Sanghvi, Haijian (Jim) Zhu
Chapter 2 - Crystalline and Amorphous Solids, Pages 25-60, Geoff G.Z. Zhang, Deliang Zhou
Chapter 3 - Analytical Techniques in Solid-state Characterization, Pages 61-74, Eric J. Munson
Chapter 4 - Salt Screening and Selection: New Challenges and Considerations in the Modern Pharmaceutical Research and Development Paradigm, Pages 75-86, Wei-Qin (Tony) Tong
Chapter 5 - Drug Stability and Degradation Studies, Pages 87-124, Deliang Zhou, William R. Porter, Geoff G.Z. Zhang
Chapter 6 - Excipient Compatibility, Pages 125-145, Ajit S. Narang, Venkatramana M. Rao, Krishnaswamy S. Raghavan
Chapter 7 - Theory of Diffusion and Pharmaceutical Applications, Pages 147-162, Yisheng Chen, Douglas Flanagan
Chapter 8 - Particle, Powder, and Compact Characterization, Pages 163-186, Gregory E. Amidon, Pamela J. Secreast, Deanna Mudie
Chapter 9 - Polymer Properties and Characterization, Pages 187-217, James E. Brady, Thomas Dürig, Sherwin S. Shang
Chapter 10 - Applied Statistics in Product Development, Pages 219-262, William R. Porter
Chapter 11 - Oral Absorption Basics: Pathways, Physico-chemical and Biological Factors Affecting Absorption, Pages 263,265-288, Zhongqiu Liu, Stephen Wang, Ming Hu
Chapter 12 - Oral Drug Absorption, Evaluation, and Prediction, Pages 289-308, Yongsheng Yang, Lawrence X. Yu
Chapter 13 - Fundamentals of Dissolution, Pages 309-318, Jianzhuo Wang, Douglas R. Flanagan
Chapter 14 - Dissolution Testing of Solid Products, Pages 319-340, Michelle Long, Yisheng Chen
Chapter 15 - Bioavailability and Bioequivalence, Pages 341-364, Hao Zhu, Honghui Zhou, Kathleen Seitz
Chapter 16 - In Vivo Evaluation of Oral Dosage Form Performance, Pages 365-378, Honghui Zhou, Kathleen Seitz
Chapter 17 - In Vitro–In Vivo Correlations: Fundamentals, Development Considerations, and Applications, Pages 379-406, Yihong Qiu
Chapter 18 - Integration of Physical, Chemical, Mechanical, and Biopharmaceutical Properties in Solid Oral Dosage Form Development, Pages 407,409-441, Xiaorong He
Chapter 19 - Improving the Oral Absorption of Poorly Soluble Drugs Using SEDDS and S-SEDDS Formulations, Pages 443-468, Walt Morozowich, Ping Gao
Chapter 20 - Rational Design of Oral Modified-Release Drug Delivery Systems, Pages 469-499, Yihong Qiu
Chapter 21 - Development of Modified-Release Solid Oral Dosage Forms, Pages 501-517, Yihong Qiu, Guohua Zhang
Chapter 22 - Analytical Development and Validation for Solid Oral Dosage Forms, Pages 519-537, Xingchun (Frank) Fang, Geoff Carr, Ronald C. Freeze
Chapter 23 - Statistical Design and Analysis of Long-term Stability Studies for Drug Products, Pages 539-561, David LeBlond
Chapter 24 - Packaging Selection for Solid Oral Dosage Forms, Pages 563-576, Yisheng Chen
Chapter 25 - Clinical Supplies Manufacture: Strategy, Good Manufacturing Process Considerations, and Cleaning Validation, Pages 577-597, Brian W. Pack, Suchinda Stithit, Lisa Ray, Wei Chen, Jack Y. Zheng, Richard Hwang
Chapter 26 - Specification Setting and Manufacturing Process Control for Solid Oral Drug Products, Pages 599-614, Wei Chen, Suchinda Stithit, Jack Y. Zheng, Richard Hwang
Chapter 27 - Scale-up of Pharmaceutical Manufacturing Operations of Solid Dosage Forms, Pages 615-636, John Strong
Chapter 28 - Process Development, Optimization, and Scale-up: Powder Handling and Segregation Concerns, Pages 637-665, Thomas Baxter, James Prescott
Chapter 29 - Process Development and Scale-up of Wet Granulation by the High Shear Process, Pages 667-699, Lirong Liu, Michael Levin, Paul Sheskey
Chapter 30 - Process Development, Optimization, and Scale-up: Fluid-bed Granulation, Pages 701-714, Ken Yamamoto, Z. Jesse Shao
Chapter 31 - Development, Scale-up, and Optimization of Process Parameters: Roller Compaction, Pages 715-724, Timothy J. Smith, Gary Sackett, Paul Sheskey, Lirong Liu
Chapter 32 - Development, Optimization, and Scale-up of Process Parameters: Tablet Compression, Pages 725-759, Dale Natoli, Michael Levin, Lev Tsygan, Lirong Liu
Chapter 33 - Development, Optimization, and Scale-up of Process Parameters: Pan Coating, Pages 761-805, Stuart Porter, Gary Sackett, Lirong Liu
Chapter 34 - Development, Optimization, and Scale-up of Process Parameters: Wurster Coating, Pages 807-825, David Jones
Chapter 35 - Process Analytical Technology in Solid Dosage Development and Manufacturing, Pages 827-841, Nancy E. Sever, Martin Warman, Sean Mackey, Walter Dziki, Min Jiang
Chapter 36 - The Product Development Process, Pages 843,845-860, Lynn Van Campen
Chapter 37 - Product Registration and Drug Approval Process in the United States, Pages 861-883, Steven F. Hoff, Yisheng Chen
Chapter 38 - Modern Pharmaceutical Quality Regulations: Question-based Review, Pages 885-901, Wenlei Jiang, Lawrence X. Yu
Chapter 39 - Intellectual Property Law Primer, Pages 903-910, Joseph A. Fuchs
Chapter 40 - Product Lifecycle Management (LCM), Pages 911-921, Erika A. Zannou, Ping Li, Wei-Qin (Tony) Tong
Index, Pages 923-943