PRINCETON, NJ – Dec. 14, 2015 – Certara®, the global biosimulation technology-enabled drug development company, today announced that it has been honored with a 2015 R&D 100 Award in the Software/Services category for Muse® Invent™. This awards program recognizes the 100 most innovative technologies and services of the past year. Muse Invent allows researchers to … Continued
Drug developers frequently use in vitro-in vivo correlations (IVIVCs) to: Serve as a surrogate for human bioequivalence (BE) studies. Support and/or validate the use of dissolution methods and specifications. Assist in quality control during manufacturing and selecting appropriate formulations. Conventional IVIVC uses deconvolution methods such as Wagner Nelson, Loo-Riegelman and numerical deconvolution to estimate the … Continued
PRINCETON, NJ – Dec. 8, 2015 – Certara®, the global biosimulation technology-enabled drug development company, today announced the release of version 15 of its Simcyp® Population-based Simulator. The Simcyp Simulator is the pharmaceutical industry’s most sophisticated physiologically-based pharmacokinetic (PBPK) modeling and simulation platform for determining first-in-human dose selection, predicting drug-drug interactions (DDIs), understanding drug disposition … Continued
Pharmacometrics uses mathematical models of biology, pharmacology, disease, and physiology to describe and quantify interactions between drugs and patients, including beneficial effects and adverse effects. I recently had the pleasure of talking to a thought leader, Dr. Lawrence Lesko, about the history of pharmacometrics and how it will continue to shape drug development in the … Continued
PRINCETON, NJ – Dec. 1, 2015 – Certara®, the global biosimulation technology-enabled drug development company, today announced that it has appointed Professor Piet van der Graaf, PharmD, PhD, as its vice president of quantitative systems pharmacology (QSP) and the head of its new Simcyp® QSP organization. Van der Graaf is professor of systems pharmacology, chair … Continued
PRINCETON, NJ – Dec. 1, 2015 – Certara®, the global biosimulation technology-enabled drug development company, today announced that it has acquired XenologiQ, a UK-based quantitative systems pharmacology (QSP) consultancy. “This transaction strengthens Certara’s modeling and simulation capabilities, increases its leadership in mechanistic pharmacology, and supports the company’s precision medicine vision,” said Certara Chief Executive Officer … Continued
Ever noticed how people from different ethnic backgrounds respond differently to drugs? For example, you may enjoy having a few drinks with friends on the weekend. When your friends with Eastern Asian heritage drink alcohol, it’s not uncommon for their faces to turn red. This happens because many East Asians possess an enzyme deficiency for … Continued
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 … Continued
Pediatric drug development can, in many ways, be described as a “Catch 22.”It is extremely challenging (both logistically and ethically) to enroll children in clinical trials, yet without a proper and approved clinical process, physicians are left with inaccurate dosing and therapeutic approaches for children. Modeling and simulation methods, including population PK modeling, are … Continued
In teaching pharmacometrics, I’ve noticed that scientists have difficulty with certain PK/PD modeling concepts. Maybe you’ve read about some of these terms in journal articles, but didn’t know what they meant? Or you’ve heard these terms bandied about by colleagues, but felt too shy to ask them what they meant? I’ll clarify some important concepts … Continued
