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This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.
This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.
Dieser Download kann aus rechtlichen Gründen nur mit Rechnungsadresse in A, B, BG, CY, CZ, D, DK, EW, E, FIN, F, GR, HR, H, IRL, I, LT, L, LR, M, NL, PL, P, R, S, SLO, SK ausgeliefert werden.
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.
Inhaltsangabe
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 Microemulsions as Drug Delivery Systems (Raid G. Alany and Jingyuan Wen). 5.11 Transdermal Drug Delivery (C. Scott Asbill and Gary W. Bumgarner). 5.12 Vaginal Drug Delivery (José das Neves, Maria Helena Amaral, and Maria Fernanda Bahia). SECTION 6 TABLET PRODUCTION. 6.1 Pharmaceutical Preformulation: Physicochemical Properties of Excipients and Powers and Tablet Characterization (Beom-Jin Lee). 6.2 Role of Preformulation in Discovery and Development: Pharmaceutics of Solid Dosage Forms (Omathanu P. Perumal and Satheesh K. Podaralla). 6.3 Tablet Design (Eddy Castellanos Gil, Isidoro Caraballo, and Bernard Bataille). 6.4 Tablet Production Systems (Katharina M. Picker-Freyer). 6.5 Controlled Release of Drugs from Tablet Coatings (Sacide Alsoy Altinkaya). 6.6 Tablet Compression (Helton M. M. Santos and João J. M. S. Sousa). 6.7 Effects of Grinding in Pharmaceutical Tablet Production (Gavin Andrews, David Jones, Zhai Hui, Osama Abu Diak, and Gavin Walker). 6.8 Oral Extended-Release Formulations (Anette Larsson, Susanna Abrahmsén-Alami, and Anne Juppo). SECTION 7 ROLE OF NANOTECHNOLOGY. 7.1 Cyclodextrin-Based Nanomaterials in Pharmaceutical Field (Erem Bilensoy and A. Attila Hincal). 7.2 Nanotechnology in Pharmaceutical Manufacturing (Yiguang Jin). 7.3 Pharmaceutical Nanosystems: Manufacture, Characterization, and Safety (Faz Chowdhury). 7.4 Oil-in-Water Nanosized Emulsions: Medical Applications (Shunmugaperumal Tamilvanan). INDEX.
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 Microemulsions as Drug Delivery Systems (Raid G. Alany and Jingyuan Wen). 5.11 Transdermal Drug Delivery (C. Scott Asbill and Gary W. Bumgarner). 5.12 Vaginal Drug Delivery (José das Neves, Maria Helena Amaral, and Maria Fernanda Bahia). SECTION 6 TABLET PRODUCTION. 6.1 Pharmaceutical Preformulation: Physicochemical Properties of Excipients and Powers and Tablet Characterization (Beom-Jin Lee). 6.2 Role of Preformulation in Discovery and Development: Pharmaceutics of Solid Dosage Forms (Omathanu P. Perumal and Satheesh K. Podaralla). 6.3 Tablet Design (Eddy Castellanos Gil, Isidoro Caraballo, and Bernard Bataille). 6.4 Tablet Production Systems (Katharina M. Picker-Freyer). 6.5 Controlled Release of Drugs from Tablet Coatings (Sacide Alsoy Altinkaya). 6.6 Tablet Compression (Helton M. M. Santos and João J. M. S. Sousa). 6.7 Effects of Grinding in Pharmaceutical Tablet Production (Gavin Andrews, David Jones, Zhai Hui, Osama Abu Diak, and Gavin Walker). 6.8 Oral Extended-Release Formulations (Anette Larsson, Susanna Abrahmsén-Alami, and Anne Juppo). SECTION 7 ROLE OF NANOTECHNOLOGY. 7.1 Cyclodextrin-Based Nanomaterials in Pharmaceutical Field (Erem Bilensoy and A. Attila Hincal). 7.2 Nanotechnology in Pharmaceutical Manufacturing (Yiguang Jin). 7.3 Pharmaceutical Nanosystems: Manufacture, Characterization, and Safety (Faz Chowdhury). 7.4 Oil-in-Water Nanosized Emulsions: Medical Applications (Shunmugaperumal Tamilvanan). INDEX.
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