According to the FDA’s Guidance for Industry on Drug-drug interactions (DDIs), assessment of a new drug’s DDI liability has three major objectives: determining whether any interactions necessitate dosing adjustment, informing the extent of therapeutic monitoring that may be required and identifying any potential contraindications to concomitant use when lesser measures cannot mitigate risk Physiologically-based pharmacokinetic […]Read More
Author: Lisa Almond
Lisa Almond received her PhD in HIV Clinical Pharmacology in 2004 at the University of Liverpool (UK). This was followed by a one-year position as a Postdoctoral Research Assistant focusing on factors determining inter-individual variability in pharmacokinetics of antiretroviral drugs. Since joining Certara in 2005, Lisa has worked in a team of scientists studying the extrapolation of in vitro drug data to predict in vivo pharmacokinetics and DDIs using virtual populations. She has led projects for the extension of models and databases within the Simcyp Simulator and leads workshops teaching hands-on use of PBPK to simulate complex DDIs. Lisa now works in the PBPK Consultancy Services Group at Certara, using PBPK to guide clinical practice (e.g. investigating DDIs for combination therapy). Her particular areas of expertise are the prediction of CYP induction, complex drug-drug interactions and the impact of pharmacogenetics.