Pharsight Reference Library

Reference Library

Pharsight Reference Library

Case Studies

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Hermann D, Wang W, Falcoz C, Hartman D, Mandema J. Strategies to Improve Model-Based Decision-Making During Clinical Development [poster]. Presented at: Annual Meeting of the Population Approach Group in Europe (PAGE); June 2005; Pamplona, Spain. Reprinted courtesy of PAGE.

Pharsight Corporation. Case Study of Clinical Pharmacology: PK/PD Modeling of Mycophenolate Mofetil in Renal Transplants.

Sasahara K, Wada R, Gao Y. Modeling and Simulation: A Tool to Enable Efficient Clinical Drug Development. Presented at: Japanese Society of Pharmaceutical Sciences; March 29, 2005; Tokyo, Japan.

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Merdjan H. Role of PKPD Modeling and Simulation in Influencing the Design of Early Clinical Studies. [oral presentation]. Presented at: 3rd Annual Drug Development Summit. June 8-9, 2011; Zurich, Switzerland.

Dykstra K, Hodge L, Poland B, Carrothers TJ. Methods for Developing Differentiated Drug Products. [invited presentation]. Presented at: DIA/FDA/PhRMA Meeting on Modeling and Simulation in Drug Development: Quantitative Approaches for Decision Making. October 28-29, 2009; Bethesda, Maryland.

Beliveau M, Lemire I, Reimer M, Marier JF, Leonard P, Morseth S.
Pharmacokinetic (PK) Analysis and Optimal Sampling Strategy (OSS) of a Recombinant Protein (ENB-0040) in Adult and Juvenile Rats. [poster presentation].
Presented at: Society of Toxicology Annual Meeting; March 15-19, 2009; Baltimore, Maryland. Posted with permission of sponsor.

Mouksassi S, Marier JF. Modeling and Simulation for Optimal Drug Development in Pediatric Populations. [invited presentation]. Presented at: 2nd World Conference on Magic Bullets (Ehrlich II); October 3-5, 2008; Nürnberg, Germany.

Mouksassi MS, Chen C, Li J, Marier JF. PK/PD Modeling, Biomarkers and Clinical Endpoints: The Use of Cluster Analyses, Logistic Regressions, and Receiver Operator Characteristics (ROC) for Efficient Drug Development. [poster presentation]. Presented at: 9th World Congress on Clinical Pharmacology and Therapeutics (CPT); July 27-August 1, 2008; Quebec City, Canada.

Falcoz C, Wang W, Ebling W, Claret L, Iyengar S, Gehlert DR, Kielbasa W. PKPD modeling of brain receptor occupancy from animal to man for establishing the clinical dose of the NK-1 Antagonist LY686017. [poster presentation]. Presented at: Pharmacokinetics UK 2008; November 26-28, 2008; London, UK. Posted with permission of sponsor.

Carrothers TJ. Concordance Between the Exposure-QTc Response Relationship in the Pooled Phase 1 Data vs. Thorough QTc Study. [invited presentation]. Presented at: 2nd Annual DIA Cardiac Safety Conference; December 3-4, 2007; Prague, Czech Republic. Reprinted courtesy of DIA, www.diahome.org.

Lukas JC. Modeling, Simulation and Meta-Analysis in Drug Development. [invited presentation]. Presented at: First National Meeting on Modeling and Simulation in Biomedicine, November 29-30, 2007; Valencia, Spain.
View Presentation Slides in Spanish

Mao ZL, Keirns J, Gao Y, Kshirsagar S. Population Pharmacokinetic/
Pharmacodynamic Analysis of Vernakalant Hydrochloride Injection (RSD1235) in Patients With Atrial Fibrillation or Atrial Flutter. [presentation]. Amercian Society for Clinical Pharmacology and Therapeutics (ASCPT) 2007 Annual Meeting; March 21-24, 2007; Anaheim, California. Reprinted with permission of Astellas Pharma US.

Claret L, Girard P, Zuideveld KP, Jorga K, Fagerberg J, Bruno R. A Longitudinal Model for Tumor Size Measurements in Clinical Oncology Studies. [poster presentation]. Annual Meeting of the Population Approach Group in Europe (PAGE); June 2006; Bruges, Belgium.

Prins K, Poland B, Nicolas V, Porchet H, Scalfaro P, Bruno R. Modeling and Simulation of DEBIO-025 to Support Design of a Dose-Response Monotherapy Study in HIV-1 Infected Patients. [poster presentation]. Annual Meeting of the Population Approach Group in Europe (PAGE); June 2006; Bruges, Belgium.

Poland W, Bruno R, Hovde M, Wagg JK. Best Practices in Model-Based HIV Drug Development. [poster abstract P602]. Presented at: 16th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID); April 2006; Nice, France.

Dose Selection for HIV Therapy: Case Study of a Pfizer-Pharsight Collaboration. Reprinted with permission of Pfizer.

Gillespie B. Model-based Meta-analysis for Integration of Data from Multiple Sources. Presented at: Drug Information Association Workshop, Exposure/Response Best Practice: Design, Analysis and Review; Session 1; December 5, 2005; Philadelphia, PA.

Bruno R. Impact of PK/PD Modeling and Simulation in Drug Development.
Presented at: 13th North American International Society for the Study of Xenobiotics (ISSX)/20th Japanese Society for the Study of Xenobiotics (JSSX) Joint Meeting; October 23, 2005; Maui, Hawaii. Presentation delivered at invitation of Dr. Yusuke Tanigawara as part of short course entitled "Pharmacokinetics and Pharmacodynamics Bridging."

Population Pharmacokinetic Case Study: Population pharmacokinetics of olmesartan after administration of its prodrug olmesartan medoxomil in healthy volunteers and hypertensive patients. Reprinted with permission of sponsor.

Dykstra KH. Strategic Uses of Modeling and Simulation in Drug Development. Presented at: DIA 41st Annual Meeting; June 29, 2005; Washington, DC.

Lukas JC, Psimenou E, Rodriguez M, Zografidis A, Lagguranis A. Pharmacokinetics- guided targeting of mycophenolate mofetil (MMF) in combination renal transplantation treatment confirms the need for dose reduction. Presented at: Annual Meeting of the Population Approach Group in Europe (PAGE); June 2005; Pamplona, Spain. Reprinted courtesy of PAGE.

Hermann D, Wang W, Falcoz C, Hartman D, Mandema J. Strategies to Improve Model-Based Decision-Making During Clinical Development. [poster]. Presented at: Annual Meeting of the Population Approach Group in Europe (PAGE); June 2005; Pamplona, Spain. Reprinted courtesy of PAGE.

Claret L, Cox EH, McFadyen L, Pidgen A, Johnson PJ, Haughie S, Boolell M, Bruno R. Modeling and Simulation of the Telephone Sexual Activity Daily Diary (TSADD) Data of patients with female sexual arousal disorder (FSAD) treated with sildenafil (Viagra). [poster]. Presented at: Annual Meeting of the Population Approach Group in Europe (PAGE); June 2005; Pamplona, Spain.

Sasahara K, Wada R, Gao Y. Modeling and Simulation: A Tool to Enable Efficient Clinical Drug Development . Presented at: Japanese Society of Pharmaceutical Sciences; March 29, 2005; Tokyo, Japan.

Wada R. Drug and Disease Models in Cardiovascular Drug Development. Presented at: 8th World Congress on Clinical Pharmacology and Therapeutics; August 1-6, 2004; Brisbane, Australia.

Wada R. Bridging Strategies Using Clinical Trial Simulations. Presented at: 4th Kitasato-University Harvard School of Public Health Symposium; October 28, 2003; Cambridge, MA.

Korsan B, Kingsbury L. The Collaborative and Strategic Benefits of Exploring Drug Models in Clinical Development. Presented at: DIA 39th Annual Meeting; June 19, 2003; San Antonio, TX.

Gillespie WR. Use of Bayesian Modeling and Simulation for Designing and Analysis of Clinical Trials. Presented at: 2003 FDA/Industry Statistics Workshop; September 18, 2003; Bethesda, MD.

Hawley P, Amantea M, Poland B, Hammond J, Raber S, Gao Y, Lertratanakul A, Wada R. Integrated Adherence, Pharmacokinetic, and Pharmacodynamic Modeling to Design a Dose-Ranging Study of Capravirine with Kaletra in Treatment-Experienced Patients [poster]. Presented at: 4th International Workshop on the Clinical Pharmacology of HIV Therapy; March 27-29, 2003; Cannes, France.

Amantea M, Raber S, Pesano R, Garrett M, Ballow C, Lertratanakul A, Poland B, Wada R. Pharmacokinetic Model of Capravirine (CPV), a Novel Non-Nucleoside Reverse Transcriptase Inhibitor, Co-Administered with Kaletra in Healthy and HIV-Infected Subjects. [poster]. Presented at: 4th International Workshop on the Clinical Pharmacology of HIV Therapy; March 27-29, 2003; Cannes, France.

Dykstra KH. How to Leverage Prior Knowledge on Competitors and Analogues to Achieve R&D Productivity Gains Presented at: R&D Leaders Forum; April 7, 2003; Scottsdale, AZ.

Gillespie WR. High Value Applications of Modeling and Simulation (M&S) in Early Clinical Drug Development. Presented at: University of Texas, M.D. Anderson Cancer Center; April 2003; Houston, TX.