250 Label claims using PBPK without the need for additional clinical studies “Clinical Studies and Model-Informed Approaches.” This is the language typically used by the US FDA on drug labels to describe how clinical pharmacology decisions have been reached. Much more detail can be found in the Office of Clinical Pharmacology (OCP) review that supports … Continued
By Ellen Leinfuss AAPS PharmSci 360 meeting took place virtually over the past week. Not to be too ‘punny,’ but virtual drug development using mechanistic modeling took a prominent role on the agenda. Fittingly (sorry, I am on a roll), the Simcyp Simulator accounted for 10 posters in the Physiologically-Based Pharmacokinetic (PBPK) group—leading the category. … Continued
By: Ellen Leinfuss In the past, the “Top 10” described the most popular records in the music charts that week. A similar concept has been adopted in scientific circles and the American Society for Clinical Pharmacology & Therapeutics (ASCPT) now celebrates the Top 10% of scientific papers downloaded from its journals’ websites each year. We … Continued
