00793nam0-22002651i-450-99000576923040332119990530000576923FED01000576923(Aleph)000576923FED0100057692319990530d1934----km-y0itay50------baruma-------00---ParadisulDantetradus de Alexandru Marcu ; gravuri de Mac Constantinescuanic, de Silviu DragomirCraiovaScrisul Romanescuisa1934290 p.ill.23 cmAlighieri,Dante<1265-1321>38904ITUNINARICAUNIMARCBK990005769230403321GLOTT. B V E 57 (3)IST.GLOTT. S.I.FLFBCFLFBCParadisul570915UNINA05428nam 2200661Ia 450 991014062020332120230725023141.01-282-54764-X97866125476450-470-59968-50-470-59967-7(CKB)2670000000009571(EBL)487636(OCoLC)587390006(SSID)ssj0000356422(PQKBManifestationID)11925354(PQKBTitleCode)TC0000356422(PQKBWorkID)10349050(PQKB)10203962(MiAaPQ)EBC487636(Au-PeEL)EBL487636(CaPaEBR)ebr10376664(CaONFJC)MIL254764(EXLCZ)99267000000000957120090929d2010 uy 0engur|n|---|||||txtccrThe agile approach to adaptive research[electronic resource] optimizing efficiency in clinical development /Michael J. RosenbergHoboken, N.J. Wileyc20101 online resource (296 p.)Wiley series on technologies for the pharmaceutical industryDescription based upon print version of record.0-470-24751-7 Includes bibliographical references and index.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 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; References2 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 EnvironmentThe 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; References4 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 RandomizationOther 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 DevelopmentA Development ExampleApply 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 inhWiley series on technologies for the pharmaceutical industry.Drug developmentPharmaceutical industryDrug development.Pharmaceutical industry.615/.19Rosenberg Michael J974731MiAaPQMiAaPQMiAaPQBOOK9910140620203321The agile approach to adaptive research2219561UNINA05456nam 2200649Ia 450 991095895180332120250626184810.01-281-74360-797866117436040-08-053301-9(CKB)1000000000384240(EBL)344655(OCoLC)476160655(SSID)ssj0000167157(PQKBManifestationID)12008704(PQKBTitleCode)TC0000167157(PQKBWorkID)10169598(PQKB)10380783(MiAaPQ)EBC344655(Au-PeEL)EBL344655(CaPaEBR)ebr10244773(CaONFJC)MIL174360(EXLCZ)99100000000038424019981119d1999 uy 0engur|n|---|||||txtrdacontentcrdamediacrrdacarrierHandbook of biological control principles and applications of biological control /editors, Thomas S. Bellows, T.W. Fisher ; associate editors, L.E. Caltagirone ... [et al.]1st ed.San Diego Academic Pressc19991 online resource (1073 pages)Description based upon print version of record.0-12-257305-6 Includes bibliographical references.Front Cover; Handbook of Biological Control; Copyright Page; Contents; Contributors; Preface and Acknowledgments; PART I: INTRODUCTION; Chapter 1. Scope and Significance of Biological Control; Introduction; Principles and Processes; Agents, Biology, and Methods; Applications; References; Chapter 2. Theories and Mechanisms of Natural Population Regulation; Introduction; Single-Species Populations; Introduction; Interspecific Competition; Host-Parasitoid Systems; Host-Pathogen Systems; Multispecies Systems; References; PART II: PRINCIPLES AND PROCESSES; Chapter 3. Taxonomy and Biological ControlIntroduction Taxonomy: The Historical Perspective; Contributions of Biological Control to Taxonomy; Sources of Taxonomic Expertise; Literature, Reference Collections, and Voucher Specimens; Modern Systematic Tools and Techniques; References; Chapter 4. Molecular Methods in Classical Biological Control; Introduction and Rationale; Molecular Markers; Applications in Biological Control; Conclusions; References; Chapter 5. Exploration for Natural Enemies; Introduction; Areas for Search; Risk Assessment and Evaluation of Natural Enemy PotentialPlanning, Preparation, and Execution of a Foreign Collecting Trip References; Chapter 6. Quarantine; Introduction; Establishing Quarantine Facilities; Quarantine Procedures; Personnel; References; Chapter 7. Culture and Colonization; Culture of Hosts for Entomophagous Arthropods; Culture of Entomophagous Arthropods; Colonization of Entomophagous Arthropods; Addendum; References; Chapter 8. Life Table Construction and Analysis for Evaluating Biological Control Agents; Introduction; Definitions and Data Collection; Assessing Quantitative Impact of Natural EnemiesDetermining Ecological Roles of Natural Enemies Experimental Designs for Life Table Studies; Applications to Categories of Natural Enemies Other Than Parasitoids; Conclusions; References; Chapter 9. Evaluation of Biological Control with Experimental Methods; Introduction; Evaluation Techniques; Exclusion or Inclusion Techniques; Assay Techniques; Summary; References; Chapter 10. Evaluation of Results; Introduction; Naturally Occurring Biological Control; Estimating the Benefits and Costs of Classical Biological Control; Justifying the Need for Biological Control; Perceived Risk; ConclusionReferences Chapter 11. Periodic Release and Manipulation of Natural Enemies; Introduction; Augmentation; Conservation; Monitoring; Rearing; In Vitro Rearing; Conclusions; References; Chapter 12. Genetic Improvement and Other Genetic Considerations for Improving the Efficacy and Success Rate of Biological Control; Introduction; Category 1: Biological Control by Restoring a Natural Balance; Category 2: Biological Control of Secondary Pests; Category 3: Biological Control of Weeds and Pests in Novel or Disturbed Environments; Genetic Considerations for Improved Success Rates in Biological Control; Limited Opportunity for Genetic Improvement in Category 1 Cases of Biological ControlFor many years the use of chemical agents such as pesticides and herbicides has been effective in controlling the many varieties of pests that infest both agricultural crops and backyard gardens. However, these pests are gradually becoming resistant to these agents, because the agents themselves are acting as selective factors making the pests better and better able to resist and persist. As a result, the use of biological controlling agents is increasing. This book is a comprehensive and authoritative handbook of biological control.Biological controlBiological pest control agentsPestsBiological controlBiological pest control agents.PestsBiological control.632/.96Bellows T. S1830645Fisher T. W1830646MiAaPQMiAaPQMiAaPQBOOK9910958951803321Handbook of biological control4401132UNINA