Pharsight® Reference Library
Articles and Publications
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Russell J. Pharsight and Tripos Evolve, Prep PKS Online Launch. Bio-IT World [serial online]. August 10, 2009.
Corrigan BW et al. Model-Based Meta-Analyses vs. Clinical Impressionism: Challenges and Rewards. AAPS Newsmagazine, September 2007, pages 26-27. Available at www.aapspharmaceutica.com.
Weiner D, Marier JF, Hovde M. Do You Compute? Drug Discovery & Development [serial online]. September, 2007.
Weiner D. Modeling, Simulation, and the Critical Path. Drug Discovery & Development [serial online]. December, 2006.
Creating a Data Platform for Modeling and Simulation. Interview with Daniel Weiner, Ph.D., Senior Vice President, Software Products, Pharsight Corporation. Beikoku Seiyaku Gyokai Shuho (U.S. Pharmaceutical Industry Weekly Report). [serial newsletter]. July 14, 2006. Used with permission from publisher, MSA Partners LLC, New York.
Russell J. Pharsight Lands CRADA to Assist FDA with Modeling Initiative. Bio-IT World [serial online]. June 9, 2006.
Powell B, Gobburu J, Lee P. U.S. View on the Role of PK/PD in Drug Approval-Discussion on the Basis of Examples. FDA, Silver Spring, MD. Abstract of presentation delivered at The 5th International Symposium on Measurement and Kinetics of In-Vivo Drug Effects. April 2006. Leiden, Netherlands.
Clinical Modeling Hits Prime Time. Drug Discovery & Development [serial online]. March, 2006.
Kamath L. Modeling Success in PK/PD Testing. Drug Discovery & Development [serial online]. February, 2006.
PK/PD Simulation Speeds Decision Making. Bio-IT World Best Practices [serial online]. January 23, 2006.
J. Robert Powell, Edward J. Randinitis, Jack A. Cook, Richard L. Lalonde. Releasing the Human Spirit in Developing Drugs: Increasing Clinical Pharmacokinetics Productivity. International Journal of Pharmaceutical Medicine, Volume 18, Number 1, 2004, pp. 13-17(5).
Mandema JW, Hermann D, Wang W, Sheiner T, Milad M, Bakker-Arkema R, Hartman D. Model-Based Development of Gemcabene, a New Lipid-Altering Agent. AAPS Journal. 2005; 7(3). Available at AAPS website, http://aapsj.org
Russell J. Pfizer's Model of Success. Bio-IT World [serial online]. August 15, 2005. Available at http://www.bio-itworld.com/issues/2005/August-2005/bp-pfizer.
Pharsight Software Used for FDA's Critical Path Initiative [news release]. Bio-IT World. February 25, 2005. Reprinted with permission from BioWorld® today, Atlanta, Georgia.
Uehling MD. Model Patient. Bio-IT World [serial online]. December 15, 2003. Available at http://www.bio-itworld.com/archive/121503/trials.html.
Pharsight Corporation. Bibliography for Computer Assisted Trial Design (CATD).
Gabrielsson J, Weiner D. Pharmacokinetic and Pharmacodynamic Data Analysis, Concepts and Applications, 3rd ed. Stockholm, Sweden: Swedish Pharmaceutical Press; 2001. ISBN 91-8627-492-9.
Models That Take Drugs [report]. The Economist. June 9, 2005. Copyright 2005 Reprinted with permission from the Economist Newspaper Group Limited.
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Wilfley D, Van Buren DJ, Theim KR, Stein RI, Saelens BE, Ezzet F, Russian AC, Perri MG, Epstein LH. The Use of Biosimulation in the Design of a Novel Multilevel Weight Loss Maintenance Program for Overweight Children. Obesity, Volume 18, Supplement 1, pp. S91-S98; February 2010.
Chanu P, Gieschke R, Charoin JE, Pannier A, Reigner B. Population Pharmaco-kinetic/Pharmacodynamic Model for a C.E.R.A. in Both ESA-Naïve and ESA-Treated Chronic Kidney Disease Patients With Renal Anemia. The Journal of Clinical Pharmacology published 23 February 2010, doi:10.1177/0091270009343931.
Houk BE, Bello CL, Poland B, Rosen LS, Demetri GD, Motzer, RJ. Relationship between exposure to sunitinib and efficacy and tolerability endpoints in patients with cancer: results of a pharmacokinetic/pharmacodynamic meta-analysis. Cancer Chemother Pharmacol published online 5 December, 2009. DOI 10.1007/s00280-009-1170-y.
Rohatagi S, Carrothers TJ, Wagg JK, Khariton T. Is a Thorough QTc Study Necessary? The Role of Modeling and Simulation in Evaluating the QTc Prolongation Potential of Drugs. J Clin Pharmacol published Sep 4, 2009 as doi:10.1177/0091270009341184.
Claret L, Girard P, Hoff PM, Van Cutsem E, Zuideveld KP, Jorga K, Fagerberg J, Bruno R. Model-Based Prediction of Phase III Overall Survival in Colorectal Cancer on the Basis of Phase II Tumor Dynamics. Journal of Clinical Oncology published online ahead of print Jul 27 2009; 10.1200/JCO.2008.21.0807.
Bruno R, Claret L. On the Use of Change in Tumor Size to Predict Survival in Clinical Oncology Studies: Toward a New Paradigm to Design and Evaluate Phase II Studies. Clin Pharmacol Ther 86: 136-138; doi:10.1038/clpt.2009.97.
Poland B, Hodge FL, Khan A, Clemen RT, Wagner JA, Dykstra K, Krishna R. The Clinical Utility Index as a Practical Multiattribute Approach to Drug Development Decisions. Clin Pharmacol Ther advance online publication, May 20, 2009; doi:10.1038/clpt.2009.71.
Rohatagi S, Zahir H, Moberly JB, Truitt KE, Inaba S, Shimozato T, Carrothers TJ.
Use of an Exposure-Response Model to Aid Early Drug Development of an Oral Sphingosine 1-Phosphate Receptor Modulator. J Clin Pharmacol published 23 October 2008, 10.1177/0091270008325672.
Rohatagi S, Carrothers TJ, Jin JY, Jusko WJ, Khariton T, Walker J, Truitt K, Salazar DE. Model-Based Development of a PPAR-gamma Agonist, Rivoglitazone, to Aid Dose Selection and Optimize Clinical Trial Designs. J Clin Pharmacol published 21 October 2008, 10.1177/0091270008323260.
Rohatagi S, Kastrissios H, Sakahara K, Truitt K, Moberly JB, Wada R, Salazar DE. Pain relief model for a COX-2 inhibitor in patients with postoperative dental pain. Br J Clin Pharmacol. 2008 Jul;66(1):60-70.
Krishna R, Bergman AJ, Jin B, Fallon M, Cote J, Van Hoydonck P, Laethem T, Gendrano IN, Van Dyck K, Hilliard D, Laterza O, Snyder K, Chavez-Eng C, Lutz R, Chen J, Bloomfield DM, De Smet M, Van Bortel LM, Gutierrez M, Al-Huniti N, Dykstra K, Gottesdiener KM, Wagner JA. Multiple-Dose Pharmacodynamics and Pharmacokinetics of Anacetrapib, a Potent Cholesteryl Ester Transfer Protein (CETP) Inhibitor, in Healthy Subjects. Clinical Pharmacology & Therapeutics 84, 679 - 683 (25 Jun 2008).
Rohatagi S, Carrothers TJ, Kshirsagar S, Khariton T, Lee J, Salazar D. Evaluation of Population Pharmacokinetics and Exposure-Response Relationship With Coadministration of Amlodipine Besylate and Olmesartan Medoxomil. J Clin Pharmacol published 19 May 2008, 10.1177/0091270008317847.
Rohatagi S, Kastrissios H, Gao Y, Zhang N, Xu J, Moberly J, Wada R, Yoshihara K, Truitt K, Salazar D. Predictive population pharmacokinetic/pharmacodynamic model for a novel COX-2 inhibitor. J Clin Pharmacol. 2007 Mar;47(3):358-70.
Kastrissios H, Rohatagi S, Moberly J, Truitt K, Gao Y, Wada R, Takahashi M,
Kawabata K, Salazar D. Development of a predictive pharmacokinetic model for a novel cyclooxygenase-2 inhibitor. J Clin Pharmacol. 2006 May;46(5):537-48.
Claret L, Cox H, McFadyen L, Pidgen A, Johnson J, Haughie S, Boolell M, Bruno R.
Modeling and Simulation of
Sexual Activity Daily Diary Data of Patients with Female Sexual Arousal Disorder Treated with Sildenafil Citrate (Viagra®). Pharmaceutical Research. 2006;
Vol. 23, No. 8, pages 1756-1764.
Lowe D. What You Need to Know About Adaptive Trials. Pharmaceutical Executive [serial online]. July 1, 2006. Available at http://pharmexec.com.
Kazutaka Y, Gao Y, Shiga H, Wada DR, Hisaoka M. Population Pharmacokinetics of Olmesartan Following Oral Administration of its Prodrug, Olmesartan Medoxomil: In Healthy Volunteers and Hypertensive Patients. Clinical Pharmacokinetics. 2005; Volume 44, Number 12; pp. 1329-1342(14).
Mandema JW, Hermann D, Wang W, Sheiner T, Milad M, Bakker-Arkema R, Hartman D. Model-Based Development of Gemcabene, a New Lipid-Altering Agent. AAPS Journal. 2005; 7(3). Available at AAPS website, http://aapsj.org
Korsan B, Dykstra K, Pullman W. Transparent Trade-Offs: A Clinical Utility Index (CUI) Openly Evaluates a Product's Attributes — and Chance of Success Pharmaceutical Executive. March 2005.
Russell J. FDA Mulls Drug/Disease Model Library. Bio-IT World [serial online]. December 19, 2005. Available at http://www.bio-itworld.com/newsitems/2005/dec2005/12-19-05-news-fda-models
Krause A, Millard S (Editors). Applied Statistics in the Pharmaceutical Industry with Case Studies Using S-Plus. Springer-Verlag, New York; 2001. ISBN 0-387-988149.
Janssen P, Prins NH, Peeters PJ, Zuideveld KP, Lefebvre R. 5-HT7 receptor efficacy distribution throughout the canine stomach. British Journal of Pharmacology. 2004;143:331?342. Abstract and full text available online at: http://www.nature.com/bjp.
Pillai G, Gieschke R, Goggin T, Jacqmin P, Schimmer RC, Steimer JL.
A semimechanistic and mechanistic population PK-PD model for biomarker response to ibandronate, a new biophosphonate for the treatment of osteoporosis. British Jounrnal of Clinical Pharmacology. 2004, 58:6, 618-631. Available from Blackwell Publishing, Ltd.
Poland B, Wada R. Combining drug-disease and economic modelling to inform drug development decisions Drug Discovery Today. November 2001;6(22):1165-1170.
Sheiner LB, Learning vs Confirming in Clinical Drug Development, Clin. Pharmacol. Ther., 1997, 61:275-291
Reporting and Analysis Services
Mouksassi MS, Marier JF, Cyran J, Vinks AA. Clinical Trial Simulations in Pediatric Patients Using Realistic Covariates: Application to Teduglutide, a Glucagon-Like Peptide-2 Analog in Neonates and Infants With Short-Bowel Syndrome. Clinical Pharmacology & Therapeutics (2009); advance online publication 21 October 2009. doi:10.1038/clpt.2009.199.
Marier JF, Mouksassi MS, Gosselin NH, Beliveau M, Cyran J, Wallens J. Population Pharmacokinetics of Teduglutide Following Repeated Subcutanenous Administrations in Healthy Participants and in Patients With Short Bowel Syndrome and Crohn's Disease. J. Clin. Pharmacol; 2009 Sep 22. [Epub ahead of print].
Babbar S, Marier JF, Mouksassi MS, Beliveau M, Vanhove GF, Chanda S, Bley K. Pharmacokinetic Analysis of Capsaicin After Topical Administration of a High-Concentration Capsaicin Patch to Patients With Peripheral Neuropathic Pain.
Ther Drug Monit. 2009;
10.1097/FTD.0b013e3181a8b200.
Rakha EA, Elsheikh SE, Aleskandarany MA, Habashi HO, Green AR, Powe DG, El-Sayed ME, Benhasouna A, Bruet JS, Akslen LA, Evans AJ, Blamey R, Reis-Filho JS, Foulkes WD, Ellis IO. Triple-Negative Breast Cancer: Distinguishing between Basal and Nonbasal Subtypes. Clin Cancer Res 2009;15(7) April 1, 2009.
Pettersen G, Mouksassi MS, Theoret Y, Labbe L, Faure C, Nguyen B, Litalien C. Population Pharmacokinetics of Intravenous Pantoprazole in Paediatric Intensive Care Patients. Br J Clin Pharmacol; 2008; DOI:10.1111/j.1365-2125.2008.03328.x.
Marier JF, Beliveau M, Mouksassi MS, Shaw P, Cyran J, Kesavan J, Wallens J, Zahir H, Wells D, Caminis J. Pharmacokinetics, Safety, and Tolerability of Teduglutide, a Glucagon-Like Peptide-2 (GLP-2) Analog, Following Multiple Ascending Subcutaneous Administrations in Healthy Subjects. J. Clin. Pharmacol. 2008; 48; 1289; DOI: 10.1177/0091270008320605.