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1. |
Record Nr. |
UNICAMPANIAVAN0063664 |
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Titolo |
11: Sixteenth century German artists : Hans Burgkmair, the elder; Hans Schaufelein; Lucas Cranach, the elder / edited by Tilman Falk |
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Pubbl/distr/stampa |
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New York, : Abaris books, 1980 |
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ISBN |
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Descrizione fisica |
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444 p. : in gran parte ill. ; 31 cm. |
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Lingua di pubblicazione |
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Materiale a stampa |
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Livello bibliografico |
Monografia |
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2. |
Record Nr. |
UNINA9910140620203321 |
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Autore |
Rosenberg Michael J |
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Titolo |
The agile approach to adaptive research [[electronic resource] ] : optimizing efficiency in clinical development / / Michael J. Rosenberg |
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Pubbl/distr/stampa |
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Hoboken, N.J., : Wiley, c2010 |
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ISBN |
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1-282-54764-X |
9786612547645 |
0-470-59968-5 |
0-470-59967-7 |
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Descrizione fisica |
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1 online resource (296 p.) |
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Collana |
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Wiley series on technologies for the pharmaceutical industry |
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Disciplina |
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Soggetti |
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Drug development |
Pharmaceutical industry |
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Lingua di pubblicazione |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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Note generali |
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Description based upon print version of record. |
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Nota di bibliografia |
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Includes bibliographical references and index. |
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Nota di contenuto |
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The Agile Approach to Adaptive Research: Optimizing Efficiency in Clinical Development; Contents; Preface; Acknowledgments; 1 Opportunity for Efficiency; The Adaptive Solution; An Industrial Success Story; Signs of Trouble Ahead; Converging Challenges; The Struggle to |
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Replace Lost Revenues; Clinical Research Is the Key; Behind the High Costs of Clinical Development; High Costs and Increasing Prices; Growing Pressures Mandate Greater Efficiency; The High Risk of Current Development Practices; Economic Consequences of Faster Clinical Development; Thriving in a New Era; References |
2 Defining and Extending the Adaptive ApproachThe Adaptive Concept; Knowledge, Time, and Decision Making; The Value of Early Knowledge; The Spectrum of Design and Operational Adaptations; Maximizing the Adaptive Approach: Agile Clinical Development; Measure Performance in Real Time; Metrics in Action; Right Information to the Right Eyes at the Right Time; Make Timely Decisions; Organize Work in Lean Processes; Rework in Clinical Studies; Backflow of Patient Data; Match Technology with Tasks; Objections to Adaptive Methods; Integrity and Validity; The Regulatory Environment |
The Complexity of Clinical ResearchConclusion; References; 3 Design Adaptations Part One: Finding the Right Dose; Background; Types of Design Adaptations; Order of Discussion; Dosing Nomenclature; Determining Maximum Safe Dose; Single Arm; Continual Reassessment Method; Other Bayesian Dose-Finding Methods; Determining Optimal Dose (Pruning); Multiple Arms; Improvements over Conventional Approaches to Dose Finding; Dose Selection in Practice; Optimizing Dose Selection; Minimizing Costs Versus Maximizing Information; Surrogate Endpoints; Conclusion; References |
4 Design Adaptations Part Two: Additional Design ChangesSample-Size Reestimation; The Trouble with Planning Estimates; The High Cost of "Underbuilt" Studies; The Benefits of Reestimation and Rightsizing; Reestimation and Trial Stages; Rules to Restrict Reestimation; Adjusting Sample Size for Nuisance Parameters; Seamless Designs: Combining Multiple Phases; When to Consider Seamless Studies; Seamless Phase I/Phase II Trials; Seamless Phase II/Phase III Trials; Planning Issues in Seamless Trials; Phase I-II-III Designs; Adaptive Randomization; Response-Adaptive Randomization |
Other Forms of Adaptive RandomizationOther Types of Design Adaptations; Noninferiority-to-Superiority Design; Adaptive Hypotheses and Subpopulations; Treatment Switching; Conclusions; References; 5 Operational Adaptations; Design and Operational Adaptations; The Nature and Significance of Operational Adaptations; Implementing Operational Adaptations; Enrollment and Other Site Issues; Data Quality; Monitoring; Site Closeout and Database Lock; Supporting Functions for Efficient Operations; The Bottom Line; References; 6 Agile Clinical Development; Benefits of Agile Development |
A Development Example |
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Sommario/riassunto |
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Apply adaptive research to improve results in drug development The pharmaceutical industry today faces a deepening crisis: inefficiency in its core business, the development of new drugs. The Agile Approach to Adaptive Research offers a solution. It outlines how adaptive research, using already-available tools and techniques, can enable the industry to streamline clinical trials and reach decision points faster and more efficiently. With a wealth of real-world cases and examples, author Michael Rosenberg gives readers a practical overview of drug development, the problems inh |
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3. |
Record Nr. |
UNISANNIOPAL0211604 |
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Autore |
Riga, Giulio |
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Titolo |
Microsim : procedure automatiche di microzonazione sismica / Giulio Riga |
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Pubbl/distr/stampa |
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[Palermo], : D. Flaccovio, 2008 |
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ISBN |
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Descrizione fisica |
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159 p. ; 25 cm. + 1 CD Rom |
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Collana |
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CD book |
Sistema microzonazione : collana per l'individuazione del rischio sismico locale e la valutazione delle conseguenze |
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Disciplina |
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Collocazione |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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