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Certara’s Best of Blogs 2015

A selection of short essays from our blog, written to empower our customers with biosimulation and regulatory writing solutions in order to help them solve the toughest drug development problems. Certara staff contributions range in topic from pharmacometrics to systems biology to the growing importance of regulatory writing.

Author(s): Alice Ke, Ana Henry, David Hermann, Debra Fontana, Ellen Leinfuss, Helen Humphries, Iain Gardner, Keith Kleeman, Kelley Hill, Kelley Kendle, Kevin Feng, Kim Green, Krishna Machavaram, Mark Lovern, Martin Beliveau, Masoud Jamei, Michael Eckstut, Mohamad-Samer Mouksassi, Nastya Kassir, Nathalie Gosselin, Nikunjkumar Patel, Steve Sibley, Steve Toon, Suzanne Minton, Trevor Johnson, Zoe Barter
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Understanding the Relationship Between Systemic and Hepatic Exposure of Obeticholic Acid for the Treatment of Liver Disease in Patients with Cirrhosis

Obeticholic acid (OCA) is a selective and potent farnesoid X receptor (FXR) agonist in development for several chronic liver diseases. OCA is a semi-synthetic analogue of chenodeoxycholic acid (CDCA) with similar pharmacokinetic (PK) properties. There was a significant increase in systemic exposure of OCA in patients with hepatic impairment. A proportionally similar increase in systemic […]

Author(s): Jeffrey Edwards, Carl LaCerte, Thomas Peyret, Nathalie H. Gosselin, Jean-Francois Marier, Alan F. Hofmann, David Shapiro
Event: American Association for the Study of Liver Diseases (AASLD) Liver Meeting
Year: 2015
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Using Modeling and Simulation to Optimize Dosing of an Anti-infective for Children

Pediatric drug development can, in many ways, be described as a “Catch 22.” It is extremely challenging (both logistically and ethically) to enroll children in clinical trials, yet without a proper and approved clinical process, physicians are left with inaccurate dosing and therapeutic approaches for children. Modeling and simulation methods, including population PK modeling, are […]

Speaker(s): Nathalie Gosselin
Solution: Model-informed Drug Development, PK/PD Modeling & Simulation
Therapeutic Area: Infectious Disease, Pediatrics
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Motesanib’s Promise & Peril: Population PK Modeling an Anticancer Drug

When thinking about the challenges of oncology drug development, I recall the advice of the 6th century BCE military strategist, Sun Tzu: If you know the enemy and know yourself, you need not fear the result of a hundred battles. If you know yourself, but not the enemy, for every victory gained you will also […]

Solution: PK/PD Modeling & Simulation
Therapeutic Area: Oncology/Hematology
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