Clinical Trial Simulations

Applications and Trends

Editors:

ISBN: 978-1-4419-7414-3 (Print) 978-1-4419-7415-0 (Online)

Table of contents (22 chapters)

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  1. Front Matter

    Pages i-xvi

  2. Clinical Trial Simulation and Quantitative Pharmacology

    1. Front Matter

      Pages 13-13

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      Book Chapter

      Pages 1-11

      Clinical Trial Simulation and Quantitative Pharmacology

  3. Application of M&S in Regulatory Decisions

    1. Front Matter

      Pages 13-13

    2. No Access

      Book Chapter

      Pages 15-36

      Contribution of Modeling and Simulation Studies in the Regulatory Review: A European Regulatory Perspective

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      Book Chapter

      Pages 37-57

      Contribution of Modeling and Simulation in the Regulatory Review and Decision-Making: U.S. FDA Perspective

  4. Strategic Applications of M&S in Drug Development

    1. Front Matter

      Pages 59-59

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      Book Chapter

      Pages 61-83

      Decision-Making in Drug Development: Application of a Model Based Framework for Assessing Trial Performance

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      Book Chapter

      Pages 85-107

      Decision-Making in Drug Development: Application of a Clinical Utility IndexSM

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      Book Chapter

      Pages 109-130

      Adaptive Trial Designs

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      Book Chapter

      Pages 131-148

      Keys of Collaboration to Enhance Efficiency and Impact of Modeling and Simulation

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      Book Chapter

      Pages 149-172

      Leveraging Pharmacometrics in Early Phase Anti-inflamatory Drug Development

  5. Application of M&S in Selected Therapeutic Areas

    1. Front Matter

      Pages 173-173

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      Book Chapter

      Pages 175-198

      The Application of Drug-Disease Models in the Development of Anti-Hyperglycemic Agents

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      Book Chapter

      Pages 199-226

      Modeling and Simulation in the Development of Cardiovascular Agents

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      Book Chapter

      Pages 227-250

      Viral Dynamic Modeling and Simulations in HIV and Hepatitis C

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      Book Chapter

      Pages 251-279

      A Model-Based PK/PD Antimicrobial Chemotherapy Drug Development Platform to Simultaneously Combat Infectious Diseases and Drug Resistance

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      Book Chapter

      Pages 281-306

      PKPD and Disease Modeling: Concepts and Applications to Oncology

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      Book Chapter

      Pages 307-323

      Application of Pharmacokinetic–Pharmacodynamic Modeling and Simulation for Erythropoietic Stimulating Agents

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      Book Chapter

      Pages 325-340

      Model Based Development of an Agent for the Treatment of Generalized Anxiety Disorder

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      Book Chapter

      Pages 341-357

      Balancing Efficacy and Safety in the Clinical Development of an Atypical Antipsychotic, Paliperidone Extended-Release

  6. Expanded Applications of M&S

    1. Front Matter

      Pages 359-359

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      Book Chapter

      Pages 361-396

      Application of Modeling and Simulation in the Development of Protein Drugs

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      Book Chapter

      Pages 397-429

      Modeling and Simulation in Pediatric Research and Development

  7. Evolving Methodologies in M&S

    1. Front Matter

      Pages 431-431

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      Book Chapter

      Pages 433-455

      Disease Progression Analysis: Towards Mechanism-Based Models

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      Book Chapter

      Pages 457-482

      Using a Systems Biology Approach to Explore Hypotheses Underlying Clinical Diversity of the Renin Angiotensin System and the Response to Antihypertensive Therapies

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