Pharmaceutical Manufacturing Handbook: Production and Processes (Pharmaceutical Development Series) PDF
Preview Pharmaceutical Manufacturing Handbook: Production and Processes (Pharmaceutical Development Series)
PHARMACEUTICAL MANUFACTURING HANDBOOK Production and Processes SHAYNE COX GAD, PH.D., D.A.B.T. Gad Consulting Services Cary, North Carolina A JOHN WILEY & SONS, INC., PUBLICATION PHARMACEUTICAL MANUFACTURING HANDBOOK Production and Processes PHARMACEUTICAL MANUFACTURING HANDBOOK Production and Processes SHAYNE COX GAD, PH.D., D.A.B.T. Gad Consulting Services Cary, North Carolina A JOHN WILEY & SONS, INC., PUBLICATION Copyright © 2008 by John Wiley & Sons, Inc. 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ISBN: 978-0-470-25958-0 Printed in the United States of America 10 9 8 7 6 5 4 3 2 1 CONTRIBUTORS Susanna Abrahms é n - Alami , AstraZeneca R & D Lund, Lund, Sweden, Oral Extended - Release Formulations James Agalloco, A galloco & Associates, Belle Mead, New Jersey, S terile Product Manufacturing Fakhrul Ahsan, Texas Tech University, Amarillo, Texas, Nasal Delivery of Peptide and Nonpeptide Drugs James Akers, Akers Kennedy & Associates, Kansas City, Missouri, S terile Product Manufacturing Raid G. Alany, The University of Auckland, Auckland, New Zealand, O cular Drug Delivery; Microemulsions as Drug Delivery Systems Monique Alric, Universit é d ’ Auvergne, Clermont - Ferrand, France, Recombinant Saccharomyces Cerevisiae a s New Drug Delivery System to Gut: In Vitro Valida- tion and Oral Formulation Sacide Alsoy Altinkaya, Izmir Institute of Technology, Urla - Izmir, Turkey, Con- trolled Release of Drugs from Tablet Coatings Maria Helena Amaral, University of Porto, Porto, Portugal, V aginal Drug Delivery Anil Kumar Anal, Living Cell Technologies (Global) Limited, Auckland, New Zealand, C ontrolled - Release Dosage Forms Gavin Andrews, Queen ’ s University Belfast, Belfast, Northern Ireland, Effects of Grinding in Pharmaceutical Tablet Production Sophia G. Antimisiaris, S chool of Pharmacy, University of Patras, Rio, Greece, Liposomes and Drug Delivery vi CONTRIBUTORS Robert D. Arnold, T he University of Georgia, Athens, Georgia, B iotechnology - Derived Drug Product Development C. Scott Asbill, Samford University, Birmingham, Alabama, T ransdermal Drug Delivery Maria Fernanda Bahia, U niversity of Porto, Porto, Portugal, V aginal Drug Delivery Bernard Bataille, University of Montpelier 1, Montpellier, France, T ablet Design Gerald W. Becker, SSCI, West Lafayette, Indiana, B iotechnology - Derived Drug Product Development; Regulatory Considerations in Approval of Follow- O n Protein Drug Products B. Wayne Bequette, Rensselaer Polytechnic Institute, Troy, New York, F rom Pilot Plant to Manufacturing: Effect of Scale- U p on Operation of Jacketed Reactors Erem Bilensoy, Hacettepe University Faculty of Pharmacy, Ankara, Turkey, C yclo- dextrin - Based Nanomaterials in Pharmaceutical Field St é phanie Blanquet, Universit é d ’ Auvergne, Clermont - Ferrand, France, Recombi- nant Saccharomyces Cerevisiae as New Drug Delivery System to Gut: In Vitro Validation and Oral Formulation Gary W. Bumgarner, Samford University, Birmingham, Alabama, Transdermal Drug Delivery Isidoro Caraballo, University of Sevilla, Seville, Spain, T ablet Design Stephen M. Carl, Purdue University, West Lafayette, Indiana, B iotechnology - D erived Drug Product Development; Regulatory Considerations in Approval of Follow - On Protein Drug Products Sudhir S. Chakravarthi, University of Nebraska Medical Center, College of Phar- macy, Omaha, Nebraska, Biodegradable Nanoparticles D.F. Chowdhury, University of Oxford, Oxford, United Kingdom, P harmaceutical Nanosystems: Manufacture, Characterization, and Safety Barbara R. Conway, Aston University, Birmingham, United Kingdom,S olid Dosage Forms Jos é das Neves, University of Porto, Porto, Portugal, V aginal Drug Delivery Osama Abu Diak, Q ueen’ s University Belfast, Belfast, Northern Ireland, E ffects of Grinding in Pharmaceutical Tablet Production Brit S. Farstad, Instititue for Energy Technology, Isotope Laboratories, Kjeller, Norway, Radiopharmaceutical Manufacturing Dimitrios G. Fatouros, School of Pharmacy and Biomedical Sciences, Portsmouth, England, L iposomes and Drug Delivery Jelena Filipovi ç -G rč ič , Faculty of Pharmacy and Biochemistry, University of Zagreb, Zagreb, Croatia, Nasal Powder Drug Delivery CONTRIBUTORS vii Eddy Castellanos Gil, C enter of Pharmaceutical Chemistry and University of Havana, Havana, Cuba; University of Sevilla, Seville, Spain; University of Mont- pelier 1, Montpellier, France, Tablet Design Anita Hafner, Faculty of Pharmacy and Biochemistry, University of Zagreb, Zagreb, Croatia, N asal Powder Drug Delivery A. Atilla Hincal, H acettepe University Faculty of Pharmacy, Ankara, Turkey, Cyclodextrin - Based Nanomaterials in Pharmaceutical Field Michael Hindle, V irginia Commonwealth University, Richmond, Virginia, A erosol Drug Delviery Bhaskara R. Jasti, University of the Pacifi c, Stockton, California, Semisolid Dosages: Ointments, Creams, and Gels Yiguang Jin, B eijing Institute of Radiation Medicine, Beijing, China, N anotechnol- ogy in Pharmaceutical Manufacturing David Jones, Queen ’ s University Belfast, Belfast, Northern Ireland, Effects of Grinding in Pharmaceutical Tablet Production Anne Juppo, U niversity of Helsinki, Helsinki, Finland, O ral Extended- R elease Formulations Paraskevi Kallinteri, Medway School of Pharmacy, Universities of Greenwich and Kent, England, Liposomes and Drug Delivery Gregory T. Knipp, Purdue University, West Lafayette, Indiana, B iotechnology - D erived Drug Product Development; Regulatory Considerations in Approval of Follow - On Protein Drug Products Anette Larsson, Chalmers University of Technology, G ö teborg, Sweden, O ral Extended - Release Formulations Beom - Jin Lee, K angwon National University, Chuncheon, Korea, P harmaceutical Preformulation: Physiochemical Properties of Excipients and Powders and Tablet Characterization Xiaoling Li, University of the Pacifi c, Stockton, California, S emisolid Dosages: Ointments, Creams, and Gels David J. Lindley, Purdue University, West Lafayette, Indiana, B iotechnology - Derived Drug Product Development Roberto Londono, Washington State University, Pullman, Washington, Liquid Dosage Forms Ravichandran Mahalingam, University of the Pacifi c, Stockton, California, S emi- solid Dosages: Ointments, Creams, and Gels Kenneth R. Morris, P urdue University, West Lafayette, Indiana, B iotechnology - Derived Drug Product Development; Regulatory Considerations in Approval of Follow - On Protein Drug Products Erin Oliver, Rutgers, The State University of New Jersey, Piscataway, New Jersey, Biotechnology - Derived Drug Product Development; Regulatory Considerations in Approval of Follow - On Protein Drug Products
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