Presenting authoritative and engaging articles on all aspects of drug development, dosage, manufacturing, and regulation, this Third Edition enables the pharmaceutical specialist and novice alike to keep abreast of developments in this rapidly evolving and highly competitive field. A dependable reference tool and constant companion for years to come, the Third Edition will offer completely new entries that cover critical issues in the field such as the impact of genomics, biotechnology, and implants on drug discovery, targeting, delivery, and formulation. In addition, it will address new regulatory issues, such as the changes in advertising regulations, and emerging FDA procedures.
Table of Contents:
(COMPLETELY NEW AND REVISED CHAPTERS OF THE THIRD EDITION INCLUDE): 21 CFR Part 11 Revisited. Adsorption at Solid Surfaces - Pharmaceutical Applications. Alternative Medicines. Amorphous Pharmaceutical Systems. Bioavailability of Drugs and Bioequivalence. Biotechnology and Biological Preparations. Biotechnology-Derived Drug Products: Formulation Development. Biotechnology-Derived Drug Products: Stability Testing, Filling, and Packaging. Bio-validation of Steam Sterilization. Buffers, Buffering Agents, and Ionic Equilibria. Calorimetry in Pharmaceutical Research and Development. Capsules, Hard. Capsules, Soft. Clinical Supplies Manufacture: GMP Considerations. Cocrystallization. Cold Chain Distribution of Pharmaceuticals. Computer Systems Validation. Continuous Processing of Pharmaceuticals. Corrosion of Pharmaceutical Equipment. Crystal Habit Changes and Dosage Form Performance. Crystallization: Significance on Product Development, Processing, and Performance. Dendrimers. Dissolution and Dissolution Testing. Dressings in Wound Management. Drug Delivery -- Pulsatile Systems. Drug Delivery across the Blood-Brain Barrier. Drug Delivery Systems: Neutron Scattering Studies. Drug Information Systems. Drug Master Files. Drug Transporters. Dry Powder Aerosols, Emerging Technologies. Electrical Power Systems for Pharmaceutical Equipment. Electrochemical Detection for Pharmaceutical Analysis. Electrostatic Charge in Pharmaceutical Systems. European Agency for the Evaluation of Medicinal Products (EMEA). Extractables and Leachables in Drugs and Packaging. Fast-Dissolve Drug Delivery Systems. Film Coating of Oral Solid Dosage Forms. Fine Particle Processing Techniques in Pharmaceutics. Fluid Bed Processes for Forming Functional Particles. Forced Degradation Studies. Formulation Patent Issues. Fractal Geometry in Pharmaceutical and Biological Applications - A Review. Freeze Drying, Scale-Up Considerations. Gastro-Retentive Systems. Gelatin-Containing Formulations: Changes in Dissolution Characteristics. Genetic Aspects of Drug Development. Genetic Materials as Pharmaceuticals. Handling Hazardous Chemicals and Pharmaceuticals. Headspace Oxygen Analysis in Pharmaceutical Products. Hydrogels. Implantable Biomedical Devices. IV / IC Correlation. Laboratory Information Management System (LIMS). Liquid Oral Preparations. Materials of Construction for Pharmaceutical Equipment. Melt Processes for Oral Solid Dosage Forms. Metabolite Identification in Drug Discovery. Microbiologic Monitoring of Controlled Processes. Microencapsulation Technology. Milling of Pharmaceuticals. Molecular and Cellular Approaches to Lead Optimization in Pharmaceutical Development. Nanoparticle Engineering. Needle-Free Drug Delivery. Neural Computing and Formulation Optimization. Noninvasive Protein and Peptide Delivery. Nonprescription Drugs. Nutraceutical Supplements. Oligonucleotides: Bioanalytical Techniques. Packaging Systems: Compendial Requirements. Particle Engineering. Particle Size Control during Crystallization. Patents -- International Perspective. Peptides and Proteins -- Nasal Absorption. Pharmacogenomics and Genomic Technologies. Pharmacokinetics: Effects of Food and Fasting. Pilot Plant Design. Pilot Plant Operation. PK/PD Modeling and Simulations in Drug Development. Polymeric Delivery Systems for Poorly Soluble Drugs. Polymers in Transdermal Delivery Systems. Population Pharmacokinetics. Powder Sampling. Preformulation Studies on Drugs. Proteomics, Pharmaceutical Applications. Quality Assurance of Pharmaceuticals. Quality Systems Management. Radiolabelling of Pharmaceutical Aerosols and Gamma Scintigraphic Imaging for Lung Deposition. Rheology of Pharmaceutical Systems. RNAi in Drug Development
About the Author :
James Swarbrick, D.Sc., Ph.D., is the president of PharmaceuTech, Inc., Pinehurst, North Carolina, USA. He has served in a number of industrial and academic positions, including director of product development at Sterling-Winthrop Research Institute, Rensselaer, New York, and vice president for research and development and vice president for scientific affairs at AAIPharma, Wilmington, North Carolina, USA. Prior to joining AAIPharma, he was a professor and chairman of the Division of Pharmaceutics at the University of North Carolina at Chapel Hill School of Pharmacy.
Dr. Swarbrick is a Fellow of the American Association of Pharmaceutical Sciences, the Royal Society of Chemistry, and the Royal Pharmaceutical Society of Great Britain. He has also served as a member and chairman of the FDA's Generic Drugs Advisory Committee, as chairman of the PhRMA Foundation's Pharmaceutics Advisory Committee, as well as a member of the PhRMA Foundation's Scientific Advisory Committee.
Review :
"...sets the standard in the field and creates the ultimate go-to-guide on all aspects of this ever-evolving area of concentration....this [set] is like having a pharmaceutical library at your fingertips, notable for providing answers to the latest questions in a fascinating field of study." -Electric Review
"...a valuable resource... a good reference for people who work in the pharmaceutical sciences... includes in-depth articles, which are all referenced."
-Doody's Review Service
"indispensable for scientists and experts active in various stages of drug development, manufacture, marketing, and regulation."
-Reaction Kinetics and Catalysis Letters (for previous edition)
"...The depth and breadth of coverage...make it an excellent source for academic and special libraries supporting research programs in the health sciences, pharmacology, and chemical engineering."
-American Reference Books Annual (for previous edition)
"...a valuable, well presented...addition to the literature."
-The Pharmaceutical Journal (for previous edition)
"...praiseworthy....The editors and the authors are to be congratulated."
-Pharmaceutical Technology (for previous edition)
"...a valuable resource for one who wishes to quickly become familiar with specific topics in pharmaceutics....an up-to-date, expertly written convenience."
-ARBAonline (for previous edition)
"...the value of the encyclopedia is in its tremendous breadth....highly recommended...should be in the library of any company or institution involved in pharmaceuticals."
-Organic Process Research and Development (for previous edition)
"...a highly recommended set to academic health science libraries....I am not familiar with any other book that offers the same coverage."
-E-Streams (for previous edition)
"...Many of the issues addressed are complex, and the editors have succeeded in their efforts to provide up-to-date, concise, and well-written reviews from experts in their respective fields....The quality of this publication justifies its expense in any college of pharmacy, health sciences library or bookstore, or pharmaceutical industry library."
-Doody's Reviews (for previous edition)
