chapter 1 Excipients: Background/Introduction / chapter 2 Food and Drug Administration Perspective on Regulation of Pharmaceutical Excipients / chapter 3 Pharmaceutical Excipient Development—A Preclinical Challenge / chapter 4 Regulation of Pharmaceutical Excipients / chapter 5 Cyclodextrins—Enabling Excipients: A Case Study of the Development of a New Excipient—Sulfobutylether b-Cyclodextrin (CAPTISOL Cyclodextrins Provide Case Studies of New Excipient Development -- chapter 6 The Use of Food Additive Safety Evaluation Procedures as a Basis for Evaluating the Safety of New Pharmaceutical Excipients / chapter 7 Pharmacopeial Harmonization / chapter 8 Excipient Interactions / chapter 9 Improved Excipient Functionality by Coprocessing / chapter 10 A Comparison of Physical and Mechanical Properties of Common Tableting Diluents / chapter 11 Excipients for Oral Liquid Formulations / chapter 12 Use of Nonactive Pharmaceutical Excipients in Oral Drug Formulations: Biopharmaceutical Classification System Considerations / chapter 13 Excipients for Semisolid Formulations / chapter 14 Excipients for Pulmonary Formulations / chapter 15 Synergistic Combinations of Penetration Enhancers and Their Discovery by High-Throughput Screening / chapter 16 Excipient Selection and Criteria for Injectable Dosage Forms / chapter 17 Excipients for Protein Drugs / chapter 18 Excipients Used in Vaccines / chapter 19 Polymeric Excipients for Controlled Release Applications / chapter 20 Emerging Excipients in Parenteral Medications: The New Paradigm / chapter 21 Excipient Manufacturing and Good Manufacturing Practices / chapter 22 Excipient Quality Assurance: Handling, Sampling, and Regulatory Issues / chapter 23 Excipient Distribution