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Time Dependent Pharmacokinetics of Pembrolizumab in Patients with Solid Tumor and Its Correlation with Best Overall Response

Author(s): Hongshan Li, Jingyu Yu, Chao Liu, Jiang Liu, Sriram Subramaniam, Hong Zhao, Gideon Blumenthal, David Turner, Claire LiMalidi, Ahamadi, Rik de Greef, Manash Chatterjee, Anna Kondic, Julie Stone, Brian Booth, Patricia Keegan, Atiqur Rahman, Yaning Wang
Publications: Journal of Pharmacokinetics and Pharmacodynamics
Year: June 1, 2017
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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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The Special Opportunities for Modeling and Simulation in Oncology Drug Development

In his most recent New York Times Magazine piece, “The Improvisational Oncologist,” Dr. Siddhartha Mukherjee, author of The Emperor of All Maladies: A Biography of Cancer, wrote, “In an era of rapidly proliferating, precisely targeted treatments, every cancer case has to be played by ear.” Oncology treatment: yesterday, today and tomorrow Mukherjee begins his article […]

Solution: PK/PD Modeling & Simulation
Therapeutic Area: Oncology/Hematology
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How Modeling and Simulation Can Bring New Immuno-oncology Treatments to Patients

Immuno-oncology, which harnesses the patient’s own immune system to fight cancer, is one of the hottest areas in drug development today. In recent years, the FDA has granted breakthrough therapy designations to multiple immuno-oncology drugs for a variety of oncology indications including advanced non-small cell lung cancer and melanoma. Over the last two decades, PK/PD […]

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

One of the biggest recent advances in cancer therapy has been the arrival of novel immunotherapies, such as anti-PD1 antibodies, which have demonstrated remarkable efficacy in multiple tumor types. In many instances supported by the ‘Breakthrough’ status granted by the FDA, many pharmaceutical companies are making huge efforts to bring these promising treatments to cancer […]

Speaker(s): Rik de Greef
Solution: Model-informed Drug Development, PK/PD Modeling & Simulation
Therapeutic Area: Oncology/Hematology
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