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CONTRIBUTORS. PREFACE. SECTION 1 MANUFACTURING SPECIALTIES. 1.1Biotechnology-Derived Drug Product Development (Stephen M. Carl, David J.Lindley, Gregory T. Knipp, Kenneth R. Morris, Erin Oliver, Gerald W. Becker,and Robert D. Arnold). 1.2 Regulatory Considerations in Approval onFollow-On Protein Drug Products (Erin Oliver, Stephen M. Carl, Kenneth R.Morris, Gerald W. Becker, and Gregory T. Knipp). 1.3 RadiopharmaceuticalManufacturing (Brit S. Farstad and Ivan Penuelas). SECTION 2 ASEPTICPROCESSING. 2.1 Sterile Product Manufacturing (James Agalloco and JamesAkers). SECTION 3 FACILITY. 3.1 From Pilot Plant to Manufacturing:Effect of Scale-Up on Operation of Jacketed Reactors (B. Wayne Bequette).3.2 Packaging and Labeling (Maria Ines Rocha Miritello Santoro and Anil KumarSingh). 3.3 Clean-Facility Design, Construction, and Maintenance Issues(Raymond K. Schneider). SECTION 4 NORMAL DOSAGE FORMS. 4.1 Solid DosageForms (Barbara R. Conway). 4.2 Semisolid Dosages: Ointments, Creams, andGels (Ravichandran Mahalingam, Xiaoling Li, and Bhaskara R. Jasti). 4.3Liquid Dosage Forms (Maria V. Rubio-Bonilla). SECTION 5 NEW DOSAGE FORMS.5.1 Controlled-Release Dosage Forms (Anil Kumar Anal). 5.2 Progress inthe Design of Biodegradable Polymer-Based Microspheres for ParenteralControlled Delivery of Therapeutic Peptide/Protein (ShunmugaperumalTamilvanan). 5.3 Liposomes and Drug Delivery (Sophia G. Antimisiaris,Paraskevi Kallinteri, and Dimitrios G. Fatouros). 5.4 BiodegradableNanoparticles (Sudhir S. Chakravarthi and Dennis H. Robinson). 5.5Recombinant Saccharomyces cerevisiae as New Drug Delivery System to Gut: InVitro Validation and Oral Formulation (Stephanie Blanquet and Monique Alric).5.6 Nasal Delivery of Peptide and Nonpeptide Drugs (Chandan Thomas andFakhrul Ahsan). 5.7 Nasal Powder Drug Delivery (Jelena Filipovi -Gr i andAnita Hafner). 5.8 Aerosol Drug Delivery (Michael Hindle). 5.9 OcularDrug Delivery (Ilva D. Rupenthal and Raid G. Alany). 5.10 Microemulsionsas Drug Delivery Systems (Raid G. Alany and Jingyuan Wen). 5.11Transdermal Drug Delivery (C. Scott Asbill and Gary W. Bumgarner). 5.12Vaginal Drug Delivery (Jose das Neves, Maria Helena Amaral, and MariaFernanda Bahia). SECTION 6 TABLET PRODUCTION. 6.1 PharmaceuticalPreformulation: Physicochemical Properties of Excipients and Powers andTablet Characterization (Beom-Jin Lee). 6.2 Role of Preformulation inDiscovery and Development: Pharmaceutics of Solid Dosage Forms (Omathanu P.Perumal and Satheesh K. Podaralla). 6.3 Tablet Design (Eddy CastellanosGil, Isidoro Caraballo, and Bernard Bataille). 6.4 Tablet ProductionSystems (Katharina M. Picker-Freyer). 6.5 Controlled Release of Drugs fromTablet Coatings (Sacide Alsoy Altinkaya). 6.6 Tablet Compression (HeltonM. M. Santos and Joao J. M. S. Sousa). 6.7 Effects of Grinding inPharmaceutical Tablet Production (Gavin Andrews, David Jones, Zhai Hui, OsamaAbu Diak, and Gavin Walker). 6.8 Oral Extended-Release Formulations(Anette Larsson, Susanna Abrahmsen-Alami, and Anne Juppo). SECTION 7 ROLEOF NANOTECHNOLOGY. 7.1 Cyclodextrin-Based Nanomaterials in PharmaceuticalField (Erem Bilensoy and A. Attila Hincal). 7.2 Nanotechnology inPharmaceutical Manufacturing (Yiguang Jin). 7.3 PharmaceuticalNanosystems: Manufacture, Characterization, and Safety (Faz Chowdhury).7.4 Oil-in-Water Nanosized Emulsions: Medical Applications (ShunmugaperumalTamilvanan). INDEX.