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.
|Publisher:||Taylor & Francis|
|Product dimensions:||8.50(w) x 11.00(h) x 6.40(d)|
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