Pharmaceutical Manufacturing Handbook / Pharmaceutical Development Bd.1 (PDF)

CONTRIBUTORS. PREFACE. SECTION 1 MANUFACTURING SPECIALTIES. 1.1 Biotechnology-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 on Follow-On Protein Drug Products (Erin Oliver, Stephen M. Carl, Kenneth R. Morris, Gerald W. Becker, and Gregory T. Knipp). 1.3 Radiopharmaceutical Manufacturing (Brit S. Farstad and Iván Peñuelas). SECTION 2 ASEPTIC PROCESSING. 2.1 Sterile Product Manufacturing (James Agalloco and James Akers). 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 Inês Rocha Miritello Santoro and Anil Kumar Singh). 3.3 Clean-Facility Design, Construction, and Maintenance Issues (Raymond K. Schneider). SECTION 4 NORMAL DOSAGE FORMS. 4.1 Solid Dosage Forms (Barbara R. Conway). 4.2 Semisolid Dosages: Ointments, Creams, and Gels (Ravichandran Mahalingam, Xiaoling Li, and Bhaskara R. Jasti). 4.3 Liquid Dosage Forms (Maria V. Rubio-Bonilla). SECTION 5 NEW DOSAGE FORMS. 5.1 Controlled-Release Dosage Forms (Anil Kumar Anal). 5.2 Progress in the Design of Biodegradable Polymer-Based Microspheres for Parenteral Controlled Delivery of Therapeutic Peptide/Protein (Shunmugaperumal Tamilvanan). 5.3 Liposomes and Drug Delivery (Sophia G. Antimisiaris, Paraskevi Kallinteri, and Dimitrios G. Fatouros). 5.4 Biodegradable Nanoparticles (Sudhir S. Chakravarthi and Dennis H. Robinson). 5.5 Recombinant Saccharomyces cerevisiae as New Drug Delivery System to Gut: In Vitro Validation and Oral Formulation (Stéphanie Blanquet and Monique Alric). 5.6 Nasal Delivery of Peptide and Nonpeptide Drugs (Chandan Thomas and Fakhrul Ahsan). 5.7 Nasal Powder Drug Delivery (Jelena Filipovic-Grcic and Anita Hafner). 5.8 Aerosol Drug Delivery (Michael Hindle). 5.9 Ocular Drug Delivery (Ilva D. Rupenthal and Raid G. Alany). 5.10

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 twenty-nine books and numerous papers, presentations, and other publications.

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