New Trends in Radiopharmaceutical Synthesis, Quality Assurance, and Regulatory Control

1.1 Introductory Remarks.- 1.2 Overview.- 1.3 A Muscarinic Receptor Ligand: Review of the Chemistry and Applications.- 2.1 Aspects on the Synthesis and Design of 11C-Tracers for PET.- 2.2 Special Problems Associated with the Synthesis of High Specific Activity Carbon-11 Labeled Radiotracers.- 2.3 PET Radiopharmaceuticals via Reductive Carboxylation.- 2.4 [13N] Labeled Tracers, Synthesis and Applications.- 2.5 Cu1+ Assisted Nucleophilic Exchange Radiohalogenation: Application and Mechanistic Approach.- 2.6 Potential Breast Tumor Imaging Agents: Fluorotamoxifen and Derivatives.- 2.7 Fluorinated Azabicycloesters as Muscarinic Receptor Ligands for Application with PET.- 2.8 Flourine-18 Ligands for the In Vivo Study of ?-Adrenergic Receptors in the Heart and Lung.- 2.9 Design and Radiofluorination of Benzamide Dopamine D2 Receptor Ligands.- 3.1 A Synthetic Porphyrin with High Affinity for Lung Cancer Cells and Inflamed Lymphatic Tissue.- 3.2 Galium and Copper Radiopharmaceutical Chemistry.- 3.3 Radiometallating Antibodies and Autoantigenic Peptides.- 3.4 Biomedical Use of Arsenic Radioisotopes.- 3.5 Improved Extraction Efficiency of Gallium-67 After Irradiation of Zinc-68 with Protons.- 3.6 Chemistry and Concept for An Automated 72Se/72As Generator.- 3.7 Radiochemistry of Monoclonal Antibody Labeling.- 3.8 The Study on the Formulation of A Tc(V)-99m-DMS Lyophilized Instant Kit for Tumor Scintigraphy.- 3.9 A National Biomedical Tracer Facility.- 3.10 Tantalum-178-Labeled Radiopharmaceutical Synthesis Via The Intermediate Tantalum Pentachloride — A Potential Myocardial Perfusion Agent.- 3.11 Status of Lead and Bismuth for Radioimmunoimaging and Therapy.- 4.1 Use of Organolithium and Organomagnesium Reagents In Radiopharmaceutical Synthesis.- 4.2 Application of OrganosiliconChemistry to the Synthesis of Gamma and Positron Emitting Radiotracers for Use In Nuclear Imaging Studies.- 4.3 The Synthesis of Halogenated Radiopharmaceuticals using Organomercurials.- 4.4 Synthesis of Radiopharmaceuticals Via Organoboranes.- 4.5 Radiosotope Incorporation via Aryl and Alkenyl Trialkyltin Intermediates.- 5.1 Robots In the Radiopharmaceutical Laboratory: Will They Replace the Chemist?.- 5.2 The Use of Transducers for Automated Radiopharmaceutical Synthesis Procedures.- 5.3 Facilitating the Design and Operation of Computer-Controlled Radiochemistry Synthesizers with an “Electronic Toolbox”.- 5.4 Knowledge-Based Automated Radiopharmaceutical Manufacturing for Positron Emission Tomography.- 5.5 Robotic Thin Layer Chromatography Instrument for Synthetic Chemistry.- 5.6 Automated Radiochemical Processing for Clinical PET.- 5.7 Captive Solvent Methods for Fast, Simple, Carbon-11 Radioalkylation.- 6.1 Identity, Strength, Purity, Quality and Safety: Common Goals for New Drugs.- 6.2 Quality Assurance Considerations Related to “In-House” Radiopharmaceutical Preparations Utilizing Positron Emitting Radionuclides.- 6.3 The Role of High Performance Liquid Chromatography In Radiochemical/Radiopharmaceutical Synthesis and Quality Assurance.- 6.4 Experience from a National Quality Assurance System on Radiopharmaceuticals.- 6.5 Radiopharmaceutical Production for PET: Quality Assurance Practice, Experience and Issues.- 6.6 Post-Column Reactor Determination of Aluminum Concentration in Cyclotron Produced Radiorubidium.- 6.7 Implications of the Food, Drug and Cosmetic Act on the Quality Assurance of Radiopharmaceuticals used in the United States.- 6.8 Quality Assurance in Radiochemical/Radiopharmaceutical Manufacturing.- 7.1 Regulatory Control ofRadiopharmaceutics.- 7.2 Regulatory Control of Radiopharmaceuticals.- 7.3 Development of European Regulations on Radiopharmaceuticals.- 7.4 Regulation of Cyclotron Radiopharmaceutical Production and Distribution: An Agreement State Perspective.- 7.5 New Drug Approval Process for Radiopharmaceuticals.- 7.6 Abbreviated New Drug Applications (ANDAS): Future Trends in Radiopharmaceuticals.