Month: February 2016
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
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
Impact of Carprofen Administration on Stress and Nociception Responses of Calves to Cautery Dehorning
The objective of this study was to investigate the effects of carprofen administered immediately before cautery dehorning on nociception and stress. Forty Holstein calves aged approximately 6 to 8 wk old were either placebo treated and sham dehorned ( = 10) or cautery dehorned following administration of carprofen (1.4 mg/kg) subcutaneously ( = 10) or … Continued
Factors Influencing the Central Nervous System Distribution of a Novel Phosphoinositide 3-Kinase/Mammalian Target of Rapamycin Inhibitor GSK2126458: Implications for Overcoming Resistance with Combination Therapy for Melanoma Brain Metastases
Incorporating In Vitro Information on Drug Metabolism into Clinical Trial Simulations to Assess the Effect of CYP2D6 Polymorphisms on Pharmacokinetics and Pharmacodynamics: Dextromethorphan as a Model Application
In vitro-in vivo extrapolation of clearance, embedded in a clinical trial simulation, was used to investigate differences in the pharmacokinetics and pharmacodynamics of dextromethorphan between CYP2D6 poor and extensive metabolizer phenotypes. Information on the genetic variation of CYP2D6, as well as the in vitro metabolism and pharmacodynamics of dextromethorphan and its active metabolite dextrorphan, was … Continued
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