Trends on the Role of PET in Drug Development.

The Editors; Contributors; Preface; 1 Introduction on PET. Description of Basics and Principles Aren van Waarde; References; 2 Drug Development in the Pharmaceutical Industry Adrian D. Nunn; 1. Introduction; 2. Drug Approval Rates; 3. Costs of Each Stage; 4. Efficiency of Drug Development; 5. Changing Healthcare Model; 6. Comparative Effectiveness; 7. Personalized Medicine; 8. Regulatory Issues; 9. Conclusions; References; 3 Molecular Imaging Biomarkers as a Tool in Development of Novel Medicines R. Paul Maguire; 1. Summary.

2. FDA Critical Path Initiative -- Drug Development Challenge3. Drug Development Process Decision Points; 3.1 Phases of drug development; 4. Imaging Biomarkers in General; 4.1 Imaging biomarkers for early decision making; 4.2 Diagnostics; 4.2.1 Smaller likelihood ratio; 4.3 Markers of disease; 5. Imaging Biomarkers Other than Molecular Imaging; 6. Biomarkers Other than Imaging; 7. Receptor Occupancy; 7.1 Determination of in vivo KD; 7.2 Typical RO study designs; 7.3 Assumptions; 8. Thresholds for Decision Making; 8.1 Efficacy and occupancy at G-coupled protein receptors.

9. Sources of Imprecision9.1 Instrument sensitivity; 9.2 Variability of PK; 10. Safety of Molecular Imaging Probes; 11. Ideal Molecular Imaging Ligand; 11.1 Safety; 11.2 Affinity; 11.3 Non-specific binding; 11.4 Selectivity; 11.5 Easy deployment and implementation; 12. Models of PET-Pharmacokinetics -- Data Analysis; 13. Industry Academic Collaboration; 13.1 Labeling available chemical matter; 13.2 Translational imaging; 13.3 Customized therapies -- companion diagnostics; 14. Summary; References; 4 What is the Role of Positron Emission Tomography in Drug Development? Timothy J. McCarthy.

1. Introduction2. Biomarker Definitions; 3. PET as a Tool for Proof of Target; 4. PET as a Tool for Proof of Mechanism; 5. PET as a Tool for Proof of Efficacy; 6. Summary and Conclusions; References; 5 Review of 11C Preparations and Examples in Drug Development Farhad Karimi and Bengt Långstrom; 1. Choice of Radionuclide; 2. 11C Compounds; 2.1 11C precursor; 2.2 11C chemistry based on [11C]methyl iodide/triflate; 2.2.1 Palladium-mediated C-C bond formation; 2.3 11C Chemistry based on [11C]carbon monoxide; 2.3.1 [11C]Carbon monoxide insertion.

2.3.2 Organo metals mediated 11C-carbonylation reaction2.3.2.1 Palladium-mediated 11C-carbonylation reaction; 2.3.2.2 Selenium-mediated 11C-carbonylation reaction; 2.3.2.3 Rhodium-mediated 11C-carbonylation reaction; 2.3.2.4 Radical-mediated carbonylation reactions; 3. Endogenous PET-Radiopharmaceuticals; 4. Automated Synthetic Devices; References; 6 The Role of Recent Development of 18F Radiochemistry in Drug Development Farhad Karimi and Bengt Långstrom; 1. Introduction; 2. Nucleophilic 18F Fluorination; 2.1 Basic chemistry.

2.2 Influence of ionic liquid and tertiary alcohols on [18F]fluorination.

Drug development is very expensive and a fight against time. PET offers possibilities to speed up this process by adding unique in vivo information on pharmacokinetics/dynamics of a drug at an early stage. This information can help decision makers to move the drug in the drug development process or to decide to stop further developments. This unique and complete book highlights the different ways PET can be used and describes the latest trends in the various disciplines within nuclear medicine to further improve methodologies and increase the number of tools to accelerate drug development. Var.

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Includes bibliographical references and index.

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