Harnessing Open-Source Solutions: Insights From the First Open Systems Pharmacology (OSP) Community Conference. [PDF]
Dallmann A +31 more
europepmc +1 more source
Classification system proposed to guide the design, development, regulatory approval, and scaling of long acting, small- and macro-molecule parenteral products (CS-BLAP). [PDF]
Perazzolo S, Shen DD, Ho RJY.
europepmc +1 more source
Development of a Physiologically Based Pharmacokinetic (PBPK) Simulation Model for Nicotine. [PDF]
Kim B +8 more
europepmc +1 more source
Improvement of XZP8257 Dissolution Properties Through Amorphous and Mixed-Phase Precipitate Formation in Biorelevant Media. [PDF]
Zhang M +6 more
europepmc +1 more source
Integrating Experimental Physicochemical Data with PBPK Modeling to Guide the Translational Development of the Antifungal 1,3,4-Oxadiazole Derivative LMM6. [PDF]
Piai JMB +6 more
europepmc +1 more source
Global Trends in Integrating Machine Learning (ML) with Model-Informed Drug Development (MIDD): A Bibliometric and Systematic Review (2015-2025). [PDF]
Dermawan D, Chtita S, Alotaiq N.
europepmc +1 more source
Physiologically-Based Pharmacokinetic Modeling to Support Pediatric Clinical Development: An IQ Working Group Perspective on the Current Status and Challenges. [PDF]
Yates JWT +26 more
europepmc +1 more source
State of Art of Dose Individualization to Support tacrolimus drug monitoring: What's Next? [PDF]
Lloberas N +3 more
europepmc +1 more source
Physiologically based biopharmaceutics modeling of regional and colon absorption in humans
Colon absorption is a key determinant for successful development of extended release and colon targeted drug products. This is the first systematic evaluation of the ability to predict in vivo regional differences in absorption and the extent of colon ...
Patrick F Augustijns +2 more
exaly +2 more sources
For oral drug products, in vitro dissolution is the most used surrogate of in vivo dissolution and absorption. In the context of drug product quality, safe space is defined as the boundaries of in vitro dissolution, and relevant quality attributes ...
Tausif Ahmed +2 more
exaly +2 more sources

