Trends on the Role of PET in Drug Development.
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...
Clasificación: | Libro Electrónico |
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Autor principal: | |
Otros Autores: | , |
Formato: | Electrónico eBook |
Idioma: | Inglés |
Publicado: |
Singapore :
World Scientific,
2012.
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Temas: | |
Acceso en línea: | Texto completo |
Tabla de Contenidos:
- 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.