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Informationen zum Autor 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. Klappentext Pharmaceutical Manufacturing Handbook covers a range of topics to help professionals better understand the methods used in the pharmaceutical manufacturing, pharmaceutical engineering, and process engineering fields. It covers many aspects, such as the building of a facility, to the various dosage and delivery forms available, and finally to the principles of validation. Other topics include quality assurance and regulatory requirements. Without exposure to all of these topics, professionals and others in the various pharmaceutical fields will not be able to produce quality drugs. Zusammenfassung Pharmaceutical Manufacturing Handbook covers a range of topics to help professionals better understand the methods used in the pharmaceutical manufacturing, pharmaceutical engineering, and process engineering fields. Inhaltsverzeichnis Pharmaceutical Manufacturing Handbook: Production and Processes PREFACE xiii SECTION 1 MANUFACTURING SPECIALTIES 1 1.1 Biotechnology-Derived Drug Product Development 3 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 33 Erin Oliver, Stephen M. Carl, Kenneth R. Morris, Gerald W. Becker, and Gregory T. Knipp 1.3 Radiopharmaceutical Manufacturing 59 Brit S. Farstad and Iván Peñuelas SECTION 2 ASEPTIC PROCESSING 97 2.1 Sterile Product Manufacturing 99 James Agalloco and James Akers SECTION 3 FACILITY 137 3.1 From Pilot Plant to Manufacturing: Effect of Scale-Up on Operation of Jacketed Reactors 139 B. Wayne Bequette 3.2 Packaging and Labeling 159 Maria Inês Rocha Miritello Santoro and Anil Kumar Singh 3.3 Clean-Facility Design, Construction, and Maintenance Issues 201 Raymond K. Schneider SECTION 4 NORMAL DOSAGE FORMS 233 4.1 Solid Dosage Forms 235 Barbara R. Conway 4.2 Semisolid Dosages: Ointments, Creams, and Gels 267 Ravichandran Mahalingam, Xiaoling Li, and Bhaskara R. Jasti 4.3 Liquid Dosage Forms 313 Maria V. Rubio-Bonilla, Roberto Londono, and Arcesio Rubio SECTION 5 NEW DOSAGE FORMS 345 5.1 Controlled-Release Dosage Forms 347 Anil Kumar Anal 5.2 Progress in the Design of Biodegradable Polymer-Based Microspheres for Parenteral Controlled Delivery of Therapeutic Peptide/Protein 393 Shunmugaperumal Tamilvanan 5.3 Liposomes and Drug Delivery 443 Sophia G. Antimisiaris, Paraskevi Kallinteri, and Dimitrios G. Fatouros 5.4 Biodegradable Nanoparticles 535 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 565 Stéphanie Blanquet and Monique Alric 5.6 Nasal Delivery of Peptide and Nonpeptide Drugs 591 Chandan Thomas and Fakhrul Ahsan 5.7 Nasal Powder Drug Delivery 651 Jelena Filipovic Grcic and AnitaHafner 5.8 Aerosol Drug Delivery 683 Michael Hindle 5.9 Ocular Drug Delivery 729 Ilva D. Rupenthal and Raid G. Alany 5.10 Microemulsions as Drug Delivery Systems 769 Raid G. Alany and Jingyuan Wen 5....
