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Changing the Game in Drug Development: A Selection from Certara’s Best of Blogs

A selection of short essays from our blog containing insights from our thought leaders on how modeling and simulation has impacted and is continuing to reshape our approach to drug development.

Author(s): Craig Rayner, Karen Rowland Yeo, Rik de Greef, Thomas Peyret
Solution: Drug Development & Regulatory Strategy, Model-informed Drug Development, PBPK Modeling & Simulation, PK/PD Modeling & Simulation
Therapeutic Area: Central Nervous System, Oncology/Hematology, Rare/Orphan Disease
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Certara’s Best of Blogs 2016

A selection of short essays from our blog, written to empower our customers with modeling and simulation (M&S) 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 and sharing clinical trial results.

Author(s): Behtash Bahador, Bernd Wendt, Chris Lovejoy, Christine Yuying Gao, Craig Rayner, Ellen Leinfuss, Karen Rowland Yeo, Lora Killian, Manoranjenni Chetty, Neil Benson, Nirpal Singh Virdee, Patrick Smith, Rik de Greef, Serge Guzy, Steve Sibley, Suzanne Minton, Tatyana Wanderer, Thomas Peyret, Venkateswari Muthukrishnan
Solution: Clinical Trials Simulation, Drug Development & Regulatory Strategy, Model-informed Drug Development, Molecular Modeling & Simulation, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Regulatory & Medical Writing, Systems Pharmacology
Therapeutic Area: Central Nervous System, Infectious Disease, Oncology/Hematology, Pediatrics, Rare/Orphan Disease
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How to Expedite FDA Approvals of Orphan Drugs

350 million patients worldwide suffer from 7,000 rare diseases, yet only 300 of these diseases have approved treatments. This gap, impacting 95% of rare disease patients, represents a huge unmet medical need. Developing drugs for rare diseases poses a range of clinical, regulatory and commercial challenges. The small number of patients are difficult to identify […]

Author(s): Thomas Peyret
Solution: PK/PD Modeling & Simulation
Therapeutic Area: Rare/Orphan Disease
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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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