Refine Your Search

  • Solutions

  • Therapeutic Areas

  • Resource Type

Surveying the Lay of the Land for Modeling & Simulation for Global Regulatory Submissions

Analogous to how a geologist surveys the “lay of the land” to determine if oil lies underneath, or an investment advisor strives to understand the “lay of the land” to decide how to invest in a turbulent market, sponsors and regulators also need to determine how to best utilize and report modeling and simulation results […]

Author(s): Maria Saluta
Solution: Clinical Pharmacology Strategy, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Regulatory & Medical Writing
Therapeutic Area: Oncology/Hematology
More Info

Ready, Set, Model! Take PK/PD Analysis to New Heights with Phoenix 8.0

Dr. Scott Gottlieb, the Commissioner of Food and Drugs, has outlined the steps the US FDA will take to implement the 21st Century Cures Act. In outlining the plan, the Commissioner endorses modeling and simulation approaches to increase the efficiency of drug development. Certara has launched Phoenix® 8.0, the latest version of the innovative PK/PD […]

Author(s): Maria Saluta
Solution: PK/PD Modeling & Simulation
More Info

How Clinical Pharmacology Gap Analysis Can Create Value

During my years reviewing applications for the US FDA, I encountered a lot of poor planning concerning a drug’s clinical pharmacology program. This poor planning left the company either lacking data to make informed decisions or scrambling at the end of development to address unanswered issues. Early planning is key to regulatory success, not only […]

Author(s): Julie Bullock
Solution: Clinical Pharmacology Strategy, PK/PD Modeling & Simulation
More Info

Using PML to Perform Mechanistic Pharmacokinetic Modeling

Watch this webinar with Cen Guo—a graduate student at UNC-Chapel Hill—to learn how she used an integrated approach to predict alterations in bile acid disposition due to inhibition of multiple transporters using the model bile acid taurocholate (TCA).

Speaker(s): Cen Guo
Solution: PK/PD Modeling & Simulation
More Info

Using Virtual Cancer Patients to Probe the Mechanisms of Oncology Drug Disposition

Oncology drug developers face a distinct set of challenges. Oncology drugs are often very toxic which precludes conducting clinical trials in healthy volunteers. In addition, cancer patients differ from healthy people in terms of their demographics and physiology. These changes mean that the pharmacokinetics of drugs may be altered in this population compared to healthy […]

Author(s): Oliver Hatley
Solution: PBPK Modeling & Simulation
Therapeutic Area: Oncology/Hematology
More Info

Pharmacology to Payer: One Quantitative Drug Development Framework to Rule Them All

In JRR Tolkien’s Lord of the Rings, the power of the one ring forged by the evil sorcerer, Sauron, is used to control all of the disaggregated, independent kingdoms of Middle Earth. Similarly, but without the malice, the “pharmacology to the payer” (P2P) quantitative framework can be viewed as a way to unite and connect […]

Author(s): Craig Rayner
Solution: Clinical Pharmacology Strategy
Therapeutic Area: Infectious Disease
More Info

Using PBPK Models to Assess Fetal Drug Exposure

The tragedy of thalidomide provides a cautionary tale about the potential for birth defects resulting from fetal exposure to drugs. Thalidomide was used to treat morning sickness in pregnant women. By the time it was banned in 1962, more than 10,000 children had been born with thalidomide-induced birth defects. “Phocomelia,” wherein babies were born with […]

Author(s): Rick Greupink
Solution: PBPK Modeling & Simulation
More Info

Using Model-based Meta-analysis to Inform Drug Development for Autoimmune Diseases

MBMA helps sponsors design less costly and more precise trials with an eye toward achieving commercial success for both the drug and portfolio. Watch this webinar with Dr. Mark Lovern, Vice President at Certara Strategic Consulting, to learn how leveraging public data can provide value by abbreviating the “cash spiral” inherent to proprietary data.

Speaker(s): Mark Lovern
Solution: Model-based Meta-analysis, PK/PD Modeling & Simulation
More Info
Learn More LinkedIn Twitter Facebook Email Subscribe to the Blog