Modeling and simulation of oral drug absorption are widely used in discovery, development, and regulation of drug product development. Predictive absorption models are used to determine the rate and extent of oral drug absorption, facilitate lead drug candidate selection, establish formulation development strategy, and support the development of regulatory policies. The Biopharmaceutics Classification System (BCS) of drugs provides information relevant to understanding and predicting GI drug absorption and bioavailability in general that is also relevant to the absorption potential for the colon. Drug performance is important to understand from a multitude of aspects including dosing, delivery mechanism, formulation, adherence and more. There are many approaches being developed to predict drug performance in the GI tract: each with it’s strengths and limitations. 

This week’s available deck is titled “Evaluating the Utility of Gastrointestinal Systems in Predicting Drug Performance: Focus on Tiny-TIM” from Karthik Nagapudi at Genentech. Karthik was a past speaker at our Global Drug Bioavailability Enhancement Summit. This presentation overviews dissolution methodologies, the Tiny-TIM system, Tiny-TIM powder in capsule (PIC): Non-PPI vs PPIDdata and integrated Tiny-Tim and PK modeling approaches. It additionally shares case studies including decreased bioavailability of GDC-A in patients taking PPI amongst others, as well as discussing what Tiny-TIM tells us about the formulation fix.