داروساز ایرانی

Volume 1
21 CFR Part 11 Revisited = Thomas Linz and Sigrun Seeger . . . . . . . . . . . . . . . . . . . . . . . . 1
Absorption Enhancers = J. P. Remon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Absorption of Drugs = Peter G. Welling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Adsorption at Solid Surfaces: Pharmaceutical Applications = Hong Wen . . . . . . . . . . . . . . . . . 34
Adverse Drug Reactions = Therese I. Poirier and Robert L. Maher, Jr. . . . . . . . . . . . . . . . . . . 46
Advertising and Promotion of Prescription and Over-the-Counter Drug Products =
Wayne L. Pines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Alternative Medicines = Kristi L. Lenz . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Amorphous Pharmaceutical Systems = Bruno C. Hancock . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Analytical Procedures: Validation = Joachim Ermer and John S. Landy . . . . . . . . . . . . . . . . . 92
Animals in Drug Development = Farrel L. Fort . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
Aseptic Processing: Validation = James P. Agalloco and James E. Akers . . . . . . . . . . . . . . . . 127
Autoxidation and Antioxidants = John M. Pezzuto and Eun Jung Park . . . . . . . . . . . . . . . . . . 139
Bioabsorbable Polymers = Shalaby W. Shalaby . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
Bioavailability of Drugs and Bioequivalence = James T. Dalton and Charles R. Yates . . . . . . . . 164
Biodegradable Polymers as Drug Carriers = Peter Markland and Victor C. Yang . . . . . . . . . . . 176
Biologic Fluids: Analysis = Stephen G. Schulman, Judith A. Davis, and Gayle A. Brazeau . . . . . 194
Biopharmaceutics = Leon Shargel and Andrew B.C. Yu . . . . . . . . . . . . . . . . . . . . . . . . . . . 208
Biosynthesis of Drugs = Geoffrey A. Cordell and Kyung Hee Lee . . . . . . . . . . . . . . . . . . . . . 228
Biotechnology and Biological Preparations = Ronald P. Evens . . . . . . . . . . . . . . . . . . . . . . . 258
Biotechnology-Derived Drug Products: Formulation Development =
Mary E.M. Cromwell . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 281
Biotechnology-Derived Drug Products: Stability Testing, Filling, and Packaging =
Mary E.M. Cromwell . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 302
Biotransformation of Drugs = Les F. Chasseaud and D. R. Hawkins . . . . . . . . . . . . . . . . . . . 310
Bio-Validation of Steam Sterilization = Nigel A. Halls . . . . . . . . . . . . . . . . . . . . . . . . . . . . 325
Blood Substitutes: Fluorocarbon Approach = Jean G. Riess . . . . . . . . . . . . . . . . . . . . . . . . . 335
Blood Substitutes: Hemoglobin-Based Oxygen Carriers = Deanna J. Nelson . . . . . . . . . . . . . . . 353
Blow-Fill-Seal: Advanced Aseptic Processing = Deborah J. Jones . . . . . . . . . . . . . . . . . . . . . . 378
Buffers, Buffering Agents, and Ionic Equilibria = Harry G. Brittain . . . . . . . . . . . . . . . . . . . . 385
Calorimetry in Pharmaceutical Research and Development = Sophie-Dorothe´e Clas,
Chad R. Dalton, and Bruno C. Hancock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 393
Capsules, Hard = Brian E. Jones . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 406
Capsules, Soft = David H. Bergstrom, Stephen Tindal, and Wenbin Dang . . . . . . . . . . . . . . . 419
Carcinogenicity Testing: Past, Present, and Future = Koen Van Deun . . . . . . . . . . . . . . . . . . . 431
Chiroptical Analytical Methods = Neil Purdie . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 445
Chromatographic Methods of Analysis: Gas Chromatography = Isadore Kanfer,
Roderick B. Walker, and Michael F. Skinner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 463
Chromatographic Methods of Analysis: High Performance Liquid Chromatography =
R. Raghavan and Jose C. Joseph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 526
Chromatographic Methods of Analysis: Thin Layer Chromatography = Joseph Sherma . . . . . . . . 538
Clinical Data Management Systems = Samuel V. Givens, Debra Barnes,
Victoria Imber, and Barbara Perry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 551
Clinical Evaluation of Drugs = Lynda Sutton, Allen Cato, and Allen Cato III . . . . . . . . . . . . . 560
Clinical Pharmacokinetics and Pharmacodynamics = Leslie Z. Benet and
Laviero Mancinelli . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 572
Clinical Supplies Manufacture: GMP Considerations = David L. Chesney and
Mark L. Balboni . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 591
Coacervation and Phase Separation = Bruno Gander, Maria Jose Blanco-Prı´eto,
C. Thomasin, Ch. Wandrey, and D. Hunkeler . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 600
Cocrystals: Design, Properties and Formation Mechanisms = Naı´r Rodrı´guez-Hornedo,
Sarah J. Nehm, and Adivaraha Jayasankar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 615
Colloids and Colloid Drug Delivery System = Diane J. Burgess . . . . . . . . . . . . . . . . . . . . . . . 636
Coloring Agents for Use in Pharmaceuticals = David R. Schoneker . . . . . . . . . . . . . . . . . . . . 648
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I1
Volume 2
Complexation: Cyclodextrins = Gerold Mosher and Diane O. Thompson . . . . . . . . . . . . . . . . 671
Complexation: Non-Cyclodextrins = Galina N. Kalinkova . . . . . . . . . . . . . . . . . . . . . . . . . . 697
Computer Systems Validation = Orlando Lopez . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 707
Computer-Assisted Drug Design = J. Phillip Bowen and Michael Cory . . . . . . . . . . . . . . . . . . 714
Computers in Pharmaceutical Technology = Onkaram Basavapathruni . . . . . . . . . . . . . . . . . . 732
Continuous Processing of Pharmaceuticals = J. P. Remon and C. Vervaet . . . . . . . . . . . . . . . . 743
Contract Manufacturing = Duncan E. McVean . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 750
Cooling Processes and Congealing = Richard Turton and Xiu Xiu Cheng . . . . . . . . . . . . . . . . 761
Coprecipitates and Melts = Madhu K. Vadnere . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 774
Corrosion of Pharmaceutical Equipment = Paul K. Whitcraft . . . . . . . . . . . . . . . . . . . . . . . . 782
Cosmetics and Their Relation to Drugs = Martin M. Rieger . . . . . . . . . . . . . . . . . . . . . . . . . 798
Cosolvents and Cosolvency = Joseph T. Rubino . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 806
Crystal Habit Changes and Dosage Form Performance = A. K. Tiwary . . . . . . . . . . . . . . . . . . 820
Crystallization: General Principles and Significance on Product Development =
Naı´r Rodrı´guez-Hornedo, Ron C. Kelly, Brent D. Sinclair, and Jonathan M. Miller . . . . . . . 834
Crystallization: Particle Size Control = Richard D. Braatz, Mitsuko Fujiwara,
Thomas J. Wubben, and Effendi Rusli . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 858
Dendrimers = Antony D’Emanuele, David Attwood, and Ragheb Abu-Rmaileh . . . . . . . . . . . . 872
Dental Products = Sebastian G. Ciancio . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 891
Dissolution and Dissolution Testing = A. Mark Dyas and Utpal U. Shah . . . . . . . . . . . . . . . . . 908
DNA Probes for the Identification of Microbes = Wayne P. Olson . . . . . . . . . . . . . . . . . . . . . 929
Dosage Form Design: A Physicochemical Approach = Michael B. Maurin and
Anwar A. Hussain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 939
Dosage Forms and Basic Preparations: History = Robert A. Buerki and Gregory J. Higby . . . . . . 948
Dosage Forms: Lipid Excipients = Alan L. Weiner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 975
Dosage Forms: Non-Parenterals = Shailesh K. Singh and Venkatesh Naini . . . . . . . . . . . . . . . 988
Dosage Forms: Parenterals = Gayle A. Brazeau, Adam Persky, and Jintana Napaporn . . . . . . . 1001
xxiv
Dosage Regimens and Dose-Response = Chyung S. Cook and Aziz Karim . . . . . . . . . . . . . . . . 1012
Dressings in Wound Management = Sarah M.E. Cockbill . . . . . . . . . . . . . . . . . . . . . . . . . . 1023
Drug Abuse = Richard B. Seymour and David E. Smith . . . . . . . . . . . . . . . . . . . . . . . . . . . 1038
Drug Delivery Systems: Neutron Scattering Studies = M. Jayne Lawrence and
David J. Barlow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1049
Drug Delivery: Buccal Route = James C. McElnay and Carmel M. Hughes . . . . . . . . . . . . . . . 1071
Drug Delivery: Controlled Release = Yie W. Chien and Senshang Lin . . . . . . . . . . . . . . . . . . . 1082
Drug Delivery: Fast-Dissolve Systems = Vikas Agarwal, Bhavesh H. Kothari,
Derek V. Moe, and Rajendra K. Khankari . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1104
Drug Delivery: Liquid Crystals in = Christel C. Mueller-Goymann . . . . . . . . . . . . . . . . . . . . 1115
Drug Delivery: Monoclonal Antibodies = John B. Cannon, Ho-Wah Hui, and
Pramod K. Gupta . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1132
Drug Delivery: Monoclonal Antibodies in Imaging and Therapy = Ban-An Khaw . . . . . . . . . . . . 1149
Drug Delivery: Mucoadhesive Hydrogels = Hans E. Junginger, J. Coos Verhoef, and
Maya Thanou . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1169
Drug Delivery: Nanoparticles = Elias Fattal and Christine Vauthier . . . . . . . . . . . . . . . . . . . 1183
Drug Delivery: Nasal Route = Rene´ Bommer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1201
Drug Delivery: Needle-Free Systems = Toby King . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1209
Drug Delivery: Ophthalmic Route = Masood Chowhan, Alan L. Weiner, and
Haresh Bhagat . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1220
Drug Delivery: Oral Colon-Specific = Vincent H.L. Lee and Suman K. Mukherjee . . . . . . . . . . 1228
Drug Delivery: Oral Route = Brahma N. Singh and Kwon H. Kim . . . . . . . . . . . . . . . . . . . . 1242
Drug Delivery: Parenteral Route = Michael J. Akers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1266
Drug Delivery: Pulmonary Delivery = Michael T. Newhouse . . . . . . . . . . . . . . . . . . . . . . . . . 1279
Drug Delivery: Pulsatile Systems = Till Bussemer and Roland A. Bodmeier . . . . . . . . . . . . . . . 1287
Drug Delivery: Rectal Route = J. Howard Rytting and Joseph A. Fix . . . . . . . . . . . . . . . . . . . 1298
Drug Delivery: Topical and Transdermal Routes = Kenneth A. Walters . . . . . . . . . . . . . . . . . . 1311
Drug Delivery: Tumor-Targeted Systems = Yu Li and Chao-Pin Lee . . . . . . . . . . . . . . . . . . . 1326
Drug Delivery: Vaginal Route = Yie W. Chien and Chi H. Lee . . . . . . . . . . . . . . . . . . . . . . . 1339
Drug Design: Basic Principles and Applications = Jacques H. Poupaert . . . . . . . . . . . . . . . . . . 1362
Drug Development Management = James E. Tingstad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1370
Drug Information Systems = Linda Lisgarten and Michelle Wake . . . . . . . . . . . . . . . . . . . . . 1385
Drug Interactions = Daniel A. Hussar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1392
Drug Master Files = C. Jeanne Taborsky and Brian James Reamer . . . . . . . . . . . . . . . . . . . 1401
Drug Safety Evaluation = Farrel L. Fort . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1406
Dry Powder Aerosols: Emerging Technologies = Hak-Kim Chan and Nora Y.K. Chew . . . . . . . . 1428
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I1
Volume 3
Drying and Dryers = Anthony J. Hlinak and Bradley A. Clark . . . . . . . . . . . . . . . . . . . . . . 1435
Economic Characteristics of the R&D Intensive Pharmaceutical Industry = Douglas L. Cocks . . . . 1450
Effervescent Pharmaceuticals = Nils-Olof Lindberg and Henri Hansson . . . . . . . . . . . . . . . . . 1454
Elastomeric Components for the Pharmaceutical Industry = Edward J. Smith . . . . . . . . . . . . . . 1466
Electrical Power Systems for Pharmaceutical Equipment = Joseph Maida . . . . . . . . . . . . . . . . 1482
Electroanalytical Methods of Analysis: Polarography and Voltammetry =
A. David Woolfson . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1490
Electroanalytical Methods of Analysis: Potentiometry = Karel Vytras . . . . . . . . . . . . . . . . . . . 1502
Electrochemical Detection for Pharmaceutical Analysis = Craig E. Lunte and
Damon Osbourn . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1516
Electrostatic Charge in Pharmaceutical Systems = Philip Chi Lip Kwok and
Hak-Kim Chan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1535
Emulsions and Microemulsions = Gillian M. Eccleston . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1548
Enzyme Immunoassay and Related Bioanalytical Methods = John W.A. Findlay and
Ira Das . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1566
Equipment Cleaning = Destin A. LeBlanc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1580
European Agency for the Evaluation of Medicinal Products (EMEA) = David M. Jacobs . . . . . . 1593
Evaporation and Evaporators = David P. Kessler . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1600
Excipients for Pharmaceutical Dosage Forms = Patrick J. Crowley and Luigi G. Martini . . . . . . 1609
Excipients: Parenteral Dosage Forms and Their Role = Sandeep Nema,
Ron J. Brendel, and Richard Washkuhn . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1622
Excipients: Powders and Solid Dosage Forms = Hak-Kim Chan and Nora Y.K. Chew . . . . . . . . 1646
Excipients: Safety Testing = Marshall Steinberg and Florence K. Kinoshita . . . . . . . . . . . . . . 1656
Expert Systems in Pharmaceutical Product Development =
Raymond C. Rowe and Ronald J. Roberts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1663
Expiration Dating = Leslie C. Hawley and Mark D. VanArendonk . . . . . . . . . . . . . . . . . . . . 1685
Extractables and Leachables in Drugs and Packaging = Daniel L. Norwood,
Alice T. Granger, and Diane M. Paskiet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1693
Extrusion and Extruders = J. M. Newton . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1712
Film Coating of Oral Solid Dosage Forms = Linda A. Felton . . . . . . . . . . . . . . . . . . . . . . . . 1729
Filters and Filtration = Maik W. Jornitz . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1748
Flame Photometry = Thomas M. Nowak . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1759
Flavors and Flavor Modifiers = Thomas L. Reiland and John M. Lipari . . . . . . . . . . . . . . . . . 1763
Fluid Bed Processes for Forming Functional Particles =
Yoshinobu Fukumori and Hideki Ichikawa . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1773
Food and Drug Administration: Role in Drug Regulation = Roger L. Williams . . . . . . . . . . . . . 1779
Fractal Geometry in Pharmaceutical and Biological Applications = P. Tang,
Hak-Kim Chan, and Judy A. Raper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1791
Freeze Drying = Michael J. Pikal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1807
Freeze Drying, Scale-Up Considerations = Edward H. Trappler . . . . . . . . . . . . . . . . . . . . . . 1834
Gastro-Retentive Systems = Amnon Hoffman and Bashir A. Qadri . . . . . . . . . . . . . . . . . . . 1850
Gelatin-Containing Formulations: Changes in Dissolution Characteristics =
Saranjit Singh and Sariputta P. Pakhale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1861
Gels and Jellies = Clyde M. Ofner III and Cathy M. Klech-Gelotte . . . . . . . . . . . . . . . . . . . 1875
Generic Drugs and Generic Equivalency = Arthur H. Kibbe . . . . . . . . . . . . . . . . . . . . . . . . . 1891
Genetic Aspects of Drug Development = Werner Kalow . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1897
Geriatric Dosing and Dosage Forms = Cheryl A. Wiens and Carol A. Borynec . . . . . . . . . . . . . 1905
Good Clinical Practices (GCPs): An Overview = Richard A. Guarino . . . . . . . . . . . . . . . . . . . 1925
Good Laboratory Practices (GLPs): An Overview = Nigel J. Dent . . . . . . . . . . . . . . . . . . . . . 1931
Good Manufacturing Practices (GMPs): An Overview = Ira R. Berry . . . . . . . . . . . . . . . . . . . 1941
Handling Hazardous Chemicals and Pharmaceuticals = Antonio Conto . . . . . . . . . . . . . . . . . . 1948
Harmonization of Pharmacopeial Standards = Lee T. Grady and Jerome A. Halperin . . . . . . . . 1955
Headspace Oxygen Analysis in Pharmaceutical Products = Allen C. Templeton and
Robert A. Reed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1967
Health Care Systems: Outside the United States = Albert I. Wertheimer and
Sheldon X. Kong . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1977
Health Care Systems: Within the United States = Henri R. Manasse, Jr. . . . . . . . . . . . . . . . . . 1985
Homogenization and Homogenizers = Shailesh K. Singh and Venkatesh Naini . . . . . . . . . . . . . 1996
Hot-Melt Extrusion Technology = Jim W. McGinity, Michael A. Repka,
John J. Koleng, Jr., and Feng Zhang . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2004
xxvi
Hydrogels = Marı´a Dolores Blanco, Rosa Maria Olmo, and Jose´ Marı´a Teijo´n . . . . . . . . . . . . 2021
Hydrolysis of Drugs = Jason M. LePree and Kenneth A. Connors . . . . . . . . . . . . . . . . . . . . . 2040
Immunoassay = Stephen G. Schulman and G.J.P.J. Beernink . . . . . . . . . . . . . . . . . . . . . . . . 2048
In Vitro–In Vivo Correlation = J.-M. Cardot and Erick Beyssac . . . . . . . . . . . . . . . . . . . . . . 2062
Inhalation: Dry Powder = Lynn Van Campen and Geraldine Venthoye . . . . . . . . . . . . . . . . . 2077
Inhalation: Liquids = Michael E. Placke, Jeffrey Ding, and William C. Zimlich, Jr. . . . . . . . . . 2092
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I1
Volume 4
Iontophoresis = J. Bradley Phipps, Erik R. Scott, J. Richard Gyory, and
Rama V. Padmanabhan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2119
Isolators for Pharmaceutical Application = Gordon J. Farquharson . . . . . . . . . . . . . . . . . . . . 2133
Isomerism = Thomas N. Riley, Jack DeRuiter, William R. Ravis, and C. Randall Clark . . . . . . 2142
Laboratory Information Management System (LIMS) = Siri H. Segalstad . . . . . . . . . . . . . . . . 2164
Laminar Airflow Equipment: Applications and Operation = Gregory F. Peters . . . . . . . . . . . . . . 2171
Lead Optimization in Pharmaceutical Development: Molecular and Cellular Approaches =
C. K. Atterwill and M. G. Wing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2192
Lens Care Products = Masood Chowhan and Ralph Stone . . . . . . . . . . . . . . . . . . . . . . . . . 2202
Liquid Oral Preparations = Jagdish Parasrampuria and Stephen William Pitt . . . . . . . . . . . . . 2216
Lozenges = Robert W. Mendes and Hridaya Bhargava . . . . . . . . . . . . . . . . . . . . . . . . . . . 2231
Materials of Construction for Pharmaceutical Equipment = Michelle M. Gonzalez . . . . . . . . . . . 2237
Medication Errors = Diane D. Cousins . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2243
Melt Processes for Oral Solid Dosage Forms = Paul W.S. Heng and Tin Wui Wong . . . . . . . . . . 2257
Metabolite Identification in Drug Discovery = Kathleen A. Cox, Nigel Clarke, and
Diane Rindgen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2262
Metered Dose Inhalers = Sandy J.M. Munro and Alan L. Cripps . . . . . . . . . . . . . . . . . . . . . 2269
Microbial Control of Pharmaceuticals = Nigel A. Halls . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2286
Microbiologic Monitoring of Controlled Processes = Gregory F. Peters and
Marghi R. McKeon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2298
Microencapsulation Technology = Kinam Park and Yoon Yeo . . . . . . . . . . . . . . . . . . . . . . . . 2315
Microsphere Technology and Applications = Diane J. Burgess and
Anthony J. Hickey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2328
Milling of Active Pharmaceutical Ingredients = Elizabeth S. Fisher . . . . . . . . . . . . . . . . . . . . 2339
Mixing and Segregation in Tumbling Blenders = Troy Shinbrot and
Fernando J. Muzzio . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2352
Moisture in Pharmaceutical Products = R. Gary Hollenbeck . . . . . . . . . . . . . . . . . . . . . . . . 2368
Nanoparticle Engineering = Robert O. Williams III and Jason M. Vaughn . . . . . . . . . . . . . . . . 2384
Neural Computing and Formulation Optimization = Elizabeth Colbourn and
Raymond C. Rowe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2399
Non-Prescription Drugs = Sujit S. Sansgiry, Lynn Simpson, Gauri Shringarpure, and
Amit Kulkarni . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2413
Nutraceutical Supplements = G. Brian Lockwood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2431
Optimization Methods = Gareth A. Lewis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2452
Orphan Drugs = Carolyn H. Asbury . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2468
Otic Preparations = William H. Slattery III . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2475
Outsourcing = Duane B. Lakings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2486
Packaging Materials: Glass = Claudia C. Okeke and Desmond G. Hunt . . . . . . . . . . . . . . . . . 2508
Packaging Systems: Compendial Requirements = Claudia C. Okeke, Desmond G. Hunt,
Nicholas Mohr, Thomas Medwick, Eric B. Sheinin, and Roger L. Williams . . . . . . . . . . . . 2526
Paperless Documentation Systems = Ellen M. Williams and Michael McKenna . . . . . . . . . . . . 2551
Particle Engineering = Miriam K. Franchini . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2567
Particle-Size Characterization = Brian H. Kaye . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2582
Partition Coefficients = Eric J. Lien and Steven Shijun Ren . . . . . . . . . . . . . . . . . . . . . . . . 2595
Patents: International Perspective = Stuart R. Suter and Peter J. Giddings . . . . . . . . . . . . . . . 2604
Patents: United States Perspective = Lorie Ann Morgan and Jeffrey Tidwell . . . . . . . . . . . . . 2616
Pediatric Dosing and Dosage Forms = Rosalie Sagraves . . . . . . . . . . . . . . . . . . . . . . . . . . . 2629
Pelletization Techniques = Isaac Ghebre-Sellassie and Axel Knoch . . . . . . . . . . . . . . . . . . . . 2651
Peptides and Proteins: Buccal Absorption = Ashim K. Mitra, Hemant H. Alur, and
Thomas P. Johnston . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2664
Peptides and Proteins: Nasal Absorption = Takahiro Morita and Hiroshi Yamahara . . . . . . . . . 2678
Peptides and Proteins: Non-Invasive Delivery = Michael R. DeFelippis,
Muppalla Sukumar, and Natarajan Rajagopalan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2692
Peptides and Proteins: Oral Absorption = Eugene J. McNally and Jung Y. Park . . . . . . . . . . . . 2713
Peptides and Proteins: Pulmonary Absorption = Igor Gonda . . . . . . . . . . . . . . . . . . . . . . . . . 2731
Peptides and Proteins: Transdermal Absorption = Richard H. Guy,
M. Begon~a Delgado-Charro, and Diego Marro . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2741
Pharmaceutical Data: Mathematical Modeling = David W.A. Bourne . . . . . . . . . . . . . . . . . . . 2757
Pharmaceutical Excipient Testing: Regulatory and Preclinical Perspective = Paul Baldrick . . . . . 2771
Pharmaceutical Quality Assurance Microbiology Laboratories = Anthony M. Cundell . . . . . . . . 2783
Pharmacogenomics and Genomic Technologies = Daniel A. Brazeau . . . . . . . . . . . . . . . . . . . 2794
Pharmacokinetic/Pharmacodynamic Modeling and Simulations in Drug Development =
Dawei Xuan and Sally Y. Choe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2802
Pharmacokinetics: Effects of Food and Fasting = Rajesh Krishna and Bradford K. Jensen . . . . . 2816
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I1
Volume 5
Pharmacopeial Standards: European Pharmacopeia = Agne`s Artiges . . . . . . . . . . . . . . . . . . . . 2829
Pharmacopeial Standards: Japanese Pharmacopeia = Mitsuru Uchiyama . . . . . . . . . . . . . . . . . 2836
Pharmacopeial Standards: United States Pharmacopeia and National Formulary =
Lee T. Grady . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2841
Photodecomposition of Drugs = Hanne Hjorth Tonnesen . . . . . . . . . . . . . . . . . . . . . . . . . . . 2859
Physiological Factors Affecting Oral Drug Delivery = Clive G. Wilson,
Bridget O’Mahony, and Blythe Lindsay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2866
Pilot Plant Design = Mickey L. Wells, Samuel B. Balik, Ralph B. Caricofe,
Charles W. Crew, Ronald A. Sanftleben, and A. Wayne Wood . . . . . . . . . . . . . . . . . . . . 2875
Pilot Plant Operation = Mickey L. Wells, A. Wayne Wood, Samuel B. Balik,
Ralph B. Caricofe, Ronald A. Sanftleben, and Charles W. Crew . . . . . . . . . . . . . . . . . . . 2886
Plants as Drugs = Christine K. O’Neil and Charles W. Fetrow . . . . . . . . . . . . . . . . . . . . . . . 2901
Polymeric Delivery Systems for Poorly Soluble Drugs = Kang Moo Huh, Sang Cheon Lee,
Tooru Ooya, and Kinam Park . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2913
Polymers in Transdermal Delivery Systems = Fumio Kamiyama and Ying-shu Quan . . . . . . . . . 2925
Polymorphism: Pharmaceutical Aspects = Harry G. Brittain . . . . . . . . . . . . . . . . . . . . . . . . . 2935
Population Pharmacokinetics = Ene I. Ette, Alaa M. Ahmad, and Paul J. Williams . . . . . . . . . 2946
Powder Sampling = Helena J. Venables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2959
Powders as Dosage Forms = Jean-Marc Aiache and Erick Beyssac . . . . . . . . . . . . . . . . . . . . 2971
Preservation of Pharmaceutical Products = Peter Gilbert and David G. Allison . . . . . . . . . . . . 2983
Process Chemistry in the Pharmaceutical Industry = Kumar G. Gadamasetti and
Ambarish K. Singh . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2993
Prodrug Design = Bernard Testa and Joachim Mayer . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3008
xxviii
Project Management = Jerome J. Groen and Cara R. Frosch . . . . . . . . . . . . . . . . . . . . . . . . 3015
Protein Binding of Drugs = Sylvie Laganie`re and Iain J. McGilveray . . . . . . . . . . . . . . . . . . 3027
Proteomics: Pharmaceutical Applications = A. Ian Smith . . . . . . . . . . . . . . . . . . . . . . . . . . . 3041
Pyrogens and Endotoxin Detection = James F. Cooper . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3052
Quality Assurance of Pharmaceuticals = Barbara Immel . . . . . . . . . . . . . . . . . . . . . . . . . . . 3064
Quality Systems Management = Gary C. Harbour and Robert G. Kieffer . . . . . . . . . . . . . . . . 3075
Radiochemical Methods of Analysis = R. Raghavan and Jose C. Joseph . . . . . . . . . . . . . . . . . 3082
Radiolabeling of Pharmaceutical Aerosols and Gamma Scintigraphic Imaging for
Lung Deposition = Hak-Kim Chan, Stefan Eberl, and William Glover . . . . . . . . . . . . . . 3094
Receptors for Drugs: Discovery in the Post-Genomic Era = Jeffrey M. Herz and
William J. Thomsen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3108
Rheology of Pharmaceutical Systems = Fridrun Podczeck . . . . . . . . . . . . . . . . . . . . . . . . . . 3128
RNAi in Drug Development = Dmitry Samarsky, Shelley Hough, Adam Harris,
Eugene Carstea, and Peter Welch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3147
Roller Compaction Technology for the Pharmaceutical Industry = Ronald W. Miller and
Paul J. Sheskey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3159
Salt Forms: Pharmaceutical Aspects = Owen I. Corrigan . . . . . . . . . . . . . . . . . . . . . . . . . . . 3177
Scale-Up and Post Approval Changes (SUPAC) = Jerome P. Skelly . . . . . . . . . . . . . . . . . . . . 3188
Scale-Up of Solid Dosage Forms = Colleen E. Ruegger, Alan E. Royce, Matthew J. Mollan, Jr.,
Robert F. Wagner, Stephen J. Valazza, and Mark R. Mecadon . . . . . . . . . . . . . . . . . . . . 3193
Secondary Electron Microscopy in Pharmaceutical Technology = Peter C. Schmidt . . . . . . . . . . 3217
Semisolid Preparations = Guru Betageri and Sunil Prabhu . . . . . . . . . . . . . . . . . . . . . . . . . 3257
Solids: Flow Properties = Stephen A. Howard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3275
Solid-State NMR in the Characterization of Pharmaceutical Formulations =
Eric J. Munson and Joseph W. Lubach . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3297
Solubilization of Drugs in Aqueous Media = Paul B. Myrdal and Samuel H. Yalkowsky . . . . . . . 3311
Solubilizing Excipients in Pharmaceutical Formulations = Robert G. Strickley . . . . . . . . . . . . . . 3334
Spectroscopic Methods of Analysis: Atomic Absorption and Emission Spectrophotometry =
John P. Oberdier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3367
Spectroscopic Methods of Analysis: Diffuse Reflectance Spectroscopy =
Herbert Michael Heise . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3375
Spectroscopic Methods of Analysis: Fluorescence Spectroscopy = Stephen G. Schulman and
Jeffrey A. Hughes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3387
Spectroscopic Methods of Analysis: Infrared Spectroscopy = Marilyn D. Duerst . . . . . . . . . . . . 3405
Spectroscopic Methods of Analysis: Mass Spectrometry = Mike S. Lee . . . . . . . . . . . . . . . . . . 3419
Spectroscopic Methods of Analysis: Near-Infrared Spectrometry = Emil W. Ciurczak . . . . . . . . . 3434
Spectroscopic Methods of Analysis: Nuclear Magnetic Resonance Spectroscopy =
Thomas M. O’Connell and Kevin L. Facchine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3440
Spectroscopic Methods of Analysis: Ultraviolet and Visible Spectrophotometry =
R. Raghavan and Jose C. Joseph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3460
Starches and Starch Derivatives = Ann W. Newman, Ronald L. Mueller,
Imre M. Vitez, and Chris C. Kiesnowski . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3476
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I1
Volume 6
Statistical Methods = Charles Bon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3483
Statistical Process Control and Process Capability = Thomas D. Murphy,
Shailesh K. Singh, and Merlin L. Utter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3499
Sterilization: Dry Heat = Andrea Chieppo and Thomas Kupiec . . . . . . . . . . . . . . . . . . . . . . 3512
Sterilization: Ethylene Oxide = Terezinha de Jesus Andreo Pinto . . . . . . . . . . . . . . . . . . . . . 3519
xxix
Sterilization: Moist Heat = Dario Pistolesi . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3529
Sterilization: Radiation = Stephen G. Schulman and Phillip M. Achey . . . . . . . . . . . . . . . . . . 3540
Super Disintegrants: Characterization and Function = Larry L. Augsburger,
Albert W. Brzeczko, Umang Shah, and Huijeong Ashley Hahm . . . . . . . . . . . . . . . . . . . . 3553
Supercritical Fluid Technology in Pharmaceutical Research = Aaron S. Mayo and
Uday B. Kompella . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3568
Surfactants in Pharmaceutical Products and Systems = Owen I. Corrigan and
Anne Marie Healy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3583
Suspensions = Robert A. Nash . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3597
Tablet Compression: Machine Theory, Design, and Process Troubleshooting =
Michael J. Bogda . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3611
Tablet Evaluation Using Near-Infrared Spectroscopy = Christopher T. Rhodes and
Karen Morisseau . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3630
Tablet Formulation = Larry L. Augsburger and Mark J. Zellhofer . . . . . . . . . . . . . . . . . . . . 3641
Tablet Manufacture = Norman Anthony Armstrong . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3653
Tablet Manufacture by Direct Compression = Norman Anthony Armstrong . . . . . . . . . . . . . . . 3673
Tablet Press Instrumentation = Michael Levin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3684
Tablet Testing = Saeed A. Qureshi . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3707
Technology Transfer Considerations for Pharmaceuticals = Ira R. Berry . . . . . . . . . . . . . . . . . 3717
Thermal Analysis of Drugs and Drug Products = Danie`lle Giron . . . . . . . . . . . . . . . . . . . . . . 3726
Titrimetry = Vesa Virtanen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3752
Tonicity = Jaymin C. Shah . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3768
Tooling for Tableting = Annette Bauer-Brandl . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3782
Trace Level Impurity Analysis = Daniel L. Norwood, Fenghe Qiu, and James O. Mullis . . . . . . . 3797
Transdermal Delivery: Anatomical Site Influence = Nora Y.K. Chew,
Nina F. Wilkins, and Barrie C. Finnin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3814
Transdermal Delivery: Sonophoresis = Samir S. Mitragotri, Hua Tang,
E. Daniel Blankschtein, and Robert Langer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3828
Transdermal Delivery: Technologies = S. Kevin Li . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3843
Ultrasonic Nebulizers = Kevin M.G. Taylor and Orla McCallion . . . . . . . . . . . . . . . . . . . . . 3854
Unit Processes in Pharmacy: Fundamentals = Anthony J. Hickey and David Ganderton . . . . . . . 3862
Unit Processes in Pharmacy: Operations = Anthony J. Hickey and David Ganderton . . . . . . . . 3879
Vaccines and Other Immunological Products = Suresh K. Mittal, Harm HogenEsch, and
Kinam Park . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3908
Validation of Pharmaceutical Processes = Robert A. Nash . . . . . . . . . . . . . . . . . . . . . . . . . . 3928
Veterinary Dosage Forms = J. Desmond Baggot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3941
Veterinary Pharmaceuticals: Factors Influencing Their Development and Use =
Marilyn N. Martinez, Laura Hungerford, and Mark G. Papich . . . . . . . . . . . . . . . . . . . . 3978
Viral Inactivation Issues in Aseptically Processed Parenterals = J. Hotta, A. Klos,
S. Petteway, Jr., and D. Pifat . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3997
Virtual Screening = Tı´mea Polga´r and Gyo¨rgy M. Keseru¨ . . . . . . . . . . . . . . . . . . . . . . . . . . 4013
Water for Pharmaceuticals = Leonid Shnayder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4039
Water Sorption of Drugs and Dosage Forms = Mark J. Kontny and James J. Conners . . . . . . . . 4049
Waxes = Roland A. Bodmeier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4066
Wet Granulation: End-Point Determination and Scale-Up = Michael Levin . . . . . . . . . . . . . . . 4078
World Health Organization (WHO): Global Harmonization of Requirements for
Medicinal Products = Juhana E. Idanpaan-Heikkila . . . . . . . . . . . . . . . . . . . . . . . . . . 4099
X-Ray Powder Diffractometry = Raj Suryanarayanan and Suneel Rastogi . . . . . . . . . . . . . . . 4103
Zeta Potential = Luk Chiu Li and Youqin Tian . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4117
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I1