Certara Introduces Phoenix Technology Services to Optimize Pharma R&D Productivity

New Services Portfolio Supports Users of Certara’s Gold Standard Phoenix Software PRINCETON, NJ – Feb. 25, 2016 – Certara®, the global biosimulation technology-enabled drug development company, today announced the introduction of Phoenix® Technology Services. These services, led and implemented by Certara’s professional team of biosimulation (modeling and simulation) experts, include customized and ready-to-use solutions that … Continued

Inside the Mind of Pharmacometrics Pioneer, Professor Malcolm Rowland

Officially, Prof. Malcolm Rowland has retired. This scientific pioneer has been helping lay the foundation of a mechanistic understanding of pharmacokinetics since the 1960s. So you might think that he’d be ready for quieter pursuits. But this professor emeritus at the University of Manchester has no plans to stop actively teaching and guiding the pharmaceutical industry’s … Continued

Tips for Custom IVIVC Models in Phoenix

The IVIVC tool within Phoenix is a convenient and powerful tool to build an in vivo-in vitro correlation model using dissolution experiments and real in vivo profiles. This module can support your organization in formulation development and even in applying for biowaivers. The tool has a flexible library of built-in models that can be modified … Continued

How LC-MS Proteomics Is Revolutionizing PBPK Modeling and Simulation

Drug-metabolizing enzymes and drug transporters play an important role in hepatic drug metabolism and disposition and therefore have major implications on the fate of drugs in the human body. Recently, an increasing number of studies have reported proteomic expression data for pharmacologically relevant enzymes and transporters providing rich data that can be used for simulation … Continued

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 … Continued

Conventional & Mechanistic IVIVC: Complementary or Clashing Methods?

An IVIVC (in vitro-in vivo correlation) is a mathematical relationship that predicts key pharmacokinetic parameters (Cmax, AUC) from in vitro dissolution data. Drug developers use IVIVCs for 3 major reasons: To serve as a surrogate for human bioequivalence (BE) studies To support and/or validate the use of dissolution methods and specifications To assist in quality … Continued

Certara Expands Its Quantitative Systems Pharmacology Group; Appoints Professor Andrzej Kierzek

PRINCETON, NJ – Feb. 3, 2016 – Certara®, the global biosimulation technology-enabled drug development company, today announced that it has appointed Andrzej Kierzek, PhD, as head of systems modeling in its Simcyp® Quantitative Systems Pharmacology (QSP) Group. He joins Certara from the University of Surrey, UK, where he serves as professor of systems biology. Certara … Continued

Seeing the Strategic Value of Modeling and Simulation Technology

They say beauty is in the eye of the beholder. One could also say that the benefits of modeling and simulation (M&S) are in the eye of the beholder. How does the beholder, in this case, a drug developer, see the benefits of these approaches? All reputable businesses use “generally accepted accounting principles” to manage, … Continued