This webinar described how the Simcyp pregnancy-PBPK model was used to predict systemic exposure during pregnancy for two probe medications: tacrolimus and oseltamivir.
Author: Suzanne Minton
Modeling and simulation (M&S) has been widely accepted and adopted by biopharmaceutical companies and global regulatory agencies. However, its implementation in clinical care has been modest to date. Model-based approaches are essential to realize the goal of precision dosing—providing the right drug dose to maximize therapeutic benefit, while reducing risk for each individual patient. The … Continued
Will 2017 finally be the year that we overcome the blight of late-stage attrition of promising drug candidates? In a recent commentary, “Improving the Tools of Clinical Pharmacology: Goals for 2017 and Beyond,” in Clinical Pharmacology & Therapeutics, Issam Zineh and colleagues describe several areas where clinical pharmacology approaches can help reduce late-stage attrition and … Continued
Was it just me or did 2016 just seem to fly by? Reflecting on the events of the past year, I stumbled across this quote which seemed appropriate: There are years that ask questions and years that answer. [Zora Neale Hurston, Their Eyes Were Watching God] Our mission at Certara is helping our clients optimize … Continued
Did you know that only a small fraction of the tens of thousands of commercially-used chemicals have undergone toxicological assessment? Time and cost constraints, not to mention the ethical impossibility of studying these chemicals in human trials, hamper large-scale toxicological assessment. Physiologically-based toxicokinetic (PBTK) models can be leveraged to predict TK from in vitro measurements … Continued
Physiologically-based pharmacokinetic (PBPK) modeling and simulation is increasingly accepted due to the enormous cost and time saving benefits that can be realized through its ability to address regulatory concerns without always defaulting to clinical study — particularly relating to assessing complex drug-drug interactions (DDIs). Independent validation of simulations against clinical data provides confidence in the … Continued
My mom― a clinician scientist herself― would often say this about the power of pharmacology: Every medicine has its price. While most patients benefit from their medications, cases of fatal drug poisonings are tragedies wherein patients pay the ultimate price. Forensic toxicology probes cases of fatal poisonings where the cause of death is unknown. This … Continued
I recently had the pleasure of attending a 1.5 day Certara forum for management on the applications of physiologically-based pharmacokinetic (PBPK) modeling and simulation in Chicago, IL. Our CSO Dr. Amin Rostami and Certara consulting scientist, Dr. Alice Ke aptly led the forum. The highlight of the meeting was discussing the latest challenges and trends … Continued
The topic of this webinar is to introduce mathematical tools to model PK/PD systems with distributed delays.
The modeling and simulation revolution is transforming our approach to drug development. Quantitative pharmacology models can yield valuable insights that help sponsors make better decisions regarding their drug programs. For pharmacometricians to influence decision making, they must be able to effectively communicate. Dr. Joga Gobburu is a Professor at the University of Maryland Schools of … Continued