Pharsight® Reference Library
Articles and Publications
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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.
Strategic Consulting Services
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.
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
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.