Refine Your Search

  • Solutions

  • Therapeutic Areas

  • Resource Type

Optimize Immuno-oncology Drug Discovery and Development Using Quantitative Systems Pharmacology

A Quantitative Systems Pharmacology (QSP) approach for developing combination immune-oncology therapies can be used to better predict effective drug combinations, especially to more accurately correlate the physiological differences between preclinical models and human patients.

Author(s): Piet van der Graaf, Andrzej Kierzek
Solution: Drug Development & Regulatory Strategy, Model-informed Drug Development, Molecular Modeling & Simulation, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Systems Pharmacology
Therapeutic Area: Oncology/Hematology, Rare/Orphan Disease
More Info

Certara’s Simcyp PBPK M&S Technology Achieves First FDA Virtual Bioequivalence Approval for ‘Complex’ Generic Drug

PRINCETON, NJ – June 12, 2019 – Certara’s Simcyp®️ physiologically-based pharmacokinetic (PBPK) modeling and simulation technology was used to demonstrate bioequivalence (BE) for the US Food and Drug Administration (FDA) approval of a complex generic drug on the agency’s abbreviated new drug application (ANDA) pathway.

Solution: PBPK Modeling & Simulation
Therapeutic Area: Dermatology
More Info

Pirana

Pirana is a flexible and extendible modeling workbench with an intuitive graphical user interface for facilitating pharmacometric workflows for NONMEM, PsN, Xpose/R, and more. Pirana’s research tools facilitate the iterative processes used to create Pop PK/PD models, resulting in better organization and more efficient analysis of results.

Solution: Model-informed Drug Development, Molecular Modeling & Simulation, PK/PD Modeling & Simulation, Scientific Informatics
Therapeutic Area: Cardiovascular, Central Nervous System, Dermatology, Endocrinology, Infectious Disease, Oncology/Hematology, Pediatrics, Rare/Orphan Disease
More Info

Changing the Game in Oncology Drug Development and Patient Access

Maximize your understanding of your anti-cancer drug’s safety and efficacy profile to achieve regulatory and commercial success with Certara’s strategic and technology-enabled services across the entire drug development continuum – from pre-clinical first-in-human studies to regulatory submissions, health economics/outcomes research and market access value communication.

Solution: Clinical Transparency & Disclosure, Clinical Trials Simulation, Drug Development & Regulatory Strategy, Model-based Meta-analysis, Model-informed Drug Development, Molecular Modeling & Simulation, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Regulatory & Medical Writing, Systems Pharmacology
Therapeutic Area: Oncology/Hematology
More Info
Learn More LinkedIn Twitter Facebook Email