Pharmacogenomic trial design: use of a PK/PD model to explore warfarin dosing interventions through clinical trial simulation

David H. Salinger; Danny D. Shen; Kenneth Thummel; Ann K. Wittkowsky; Paolo Vicini; David L. Veenstra

doi:10.1097/fpc.0b013e3283333b80

Pharmacogenomic trial design: use of a PK/PD model to explore warfarin dosing interventions through clinical trial simulation

Pharmacogenetics and Genomics ◽

10.1097/fpc.0b013e3283333b80 ◽

2009 ◽

Vol 19 (12) ◽

pp. 965-971 ◽

Cited By ~ 4

Author(s):

David H. Salinger ◽

Danny D. Shen ◽

Kenneth Thummel ◽

Ann K. Wittkowsky ◽

Paolo Vicini ◽

...

Keyword(s):

Clinical Trial ◽

Trial Design ◽

Clinical Trial Simulation ◽

Trial Simulation ◽

Warfarin Dosing

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Combining Model‐Based Clinical Trial Simulation, Pharmacoeconomics, and Value of Information to Optimize Trial Design

CPT Pharmacometrics & Systems Pharmacology ◽

10.1002/psp4.12579 ◽

2020 ◽

Author(s):

Daniel Hill‐McManus ◽

Dyfrig A. Hughes

Keyword(s):

Clinical Trial ◽

Value Of Information ◽

Trial Design ◽

Clinical Trial Simulation ◽

Model Based ◽

Trial Simulation

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Clinical Trial Simulation To Optimize Trial Design for Fludarabine Dosing Strategies in Allogeneic Hematopoietic Cell Transplantation

CPT Pharmacometrics & Systems Pharmacology ◽

10.1002/psp4.12486 ◽

2020 ◽

Author(s):

Jurgen B. Langenhorst ◽

Thomas P.C. Dorlo ◽

Charlotte Kesteren ◽

Erik M. Maarseveen ◽

Stefan Nierkens ◽

...

Keyword(s):

Clinical Trial ◽

Cell Transplantation ◽

Trial Design ◽

Hematopoietic Cell Transplantation ◽

Hematopoietic Cell ◽

Allogeneic Hematopoietic Cell Transplantation ◽

Clinical Trial Simulation ◽

Trial Simulation ◽

Dosing Strategies

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Clinical Trial Simulation—A Case Study Incorporating Efficacy and Tolerability Dose Response

Statistics for Biology and Health - Dose Finding in Drug Development ◽

10.1007/0-387-33706-7_8 ◽

2006 ◽

pp. 106-126

Author(s):

Wayne Ewy ◽

Peter Lockwood ◽

Candace Bramson

Keyword(s):

Clinical Trial ◽

Dose Response ◽

Clinical Trial Simulation ◽

Trial Simulation

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Clinical Trial Simulation to Inform Phase 2: Comparison of Concentrated vs. Distributed First-in-Patient Study Designs in Psoriasis

CPT Pharmacometrics & Systems Pharmacology ◽

10.1038/psp.2013.32 ◽

2013 ◽

Vol 2 (7) ◽

pp. 58 ◽

Cited By ~ 8

Author(s):

MG Dodds ◽

DH Salinger ◽

J Mandema ◽

JP Gibbs ◽

MA Gibbs

Keyword(s):

Clinical Trial ◽

Clinical Trial Simulation ◽

Phase 2 ◽

Patient Study ◽

Trial Simulation ◽

Study Designs

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Sensitivity Analysis of Pharmacokinetic and Pharmacodynamic Models in Clinical Trial Simulation and Design

Drugs and the Pharmaceutical Sciences - Simulation for Designing Clinical Trials ◽

10.1201/9780203910276.ch8 ◽

2002 ◽

Author(s):

Ivan Nestorov

Keyword(s):

Clinical Trial ◽

Sensitivity Analysis ◽

Clinical Trial Simulation ◽

Trial Simulation

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Clinical Trial Simulation (CTS)

Drugs and the Pharmaceutical Sciences - Simulation for Designing Clinical Trials ◽

10.1201/9780203910276.ch10 ◽

2002 ◽

Author(s):

Lawrence Lesko ◽

Peter Lee

Keyword(s):

Clinical Trial ◽

Clinical Trial Simulation ◽

Trial Simulation

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Deﬁning Covariate Distribution Models for Clinical Trial Simulation

Simulation for Designing Clinical Trials ◽

10.1201/9780203910276-7 ◽

2002 ◽

pp. 49-72

Keyword(s):

Clinical Trial ◽

Clinical Trial Simulation ◽

Distribution Models ◽

Trial Simulation

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Clinical Trial Simulation (CTS): A Regulatory Clinical Pharmacology Perspective

Simulation for Designing Clinical Trials ◽

10.1201/9780203910276-14 ◽

2002 ◽

pp. 219-228

Keyword(s):

Clinical Trial ◽

Clinical Pharmacology ◽

Clinical Trial Simulation ◽

Trial Simulation

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Clinical Trial Simulation

Chapman & Hall/CRC Biostatistics Series - Adaptive Design Methods in Clinical Trials ◽

10.1201/9781584887775.ch11 ◽

2006 ◽

pp. 211-237

Keyword(s):

Clinical Trial ◽

Clinical Trial Simulation ◽

Trial Simulation

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A kinetic-pharmacodynamic model for clinical trial simulation of antidepressant action: Application to clomipramine–lithium interaction

Contemporary Clinical Trials ◽

10.1016/j.cct.2006.09.001 ◽

2007 ◽

Vol 28 (3) ◽

pp. 276-287 ◽

Cited By ~ 12

Author(s):

Bérangère Gruwez ◽

Marie-France Poirier ◽

Alain Dauphin ◽

Jean-Pierre Olié ◽

Michel Tod

Keyword(s):

Clinical Trial ◽

Pharmacodynamic Model ◽

Clinical Trial Simulation ◽

Lithium Interaction ◽

Trial Simulation ◽

Antidepressant Action

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