Abstract To implement Quality by Design (QbD) in drug development, scientists need tools
that link drug products properties to in vivo performance. Physiologically based absorption …

Physiologically based absorption models can be an important tool in understanding product
performance and hence implementation of Quality by Design (QbD) in drug product …

Physiologically based pharmacokinetic (PBPK) absorption modeling and simulation is
increasingly used as a tool in drug product development, not only in support of clinical …

In vitro dissolution experiments are used to qualitatively assess the impact of formulation
composition and process changes on the drug dosage form performance. However, the use …

Selection of API phase is one of the first decision points in the formulation development
process. Subsequent to phase selection, the focus shifts to the API physical properties such …

In silico absorption modeling has been performed, to assess the impact of in vitro dissolution
on in vivo performance for ZURAMPIC (lesinurad) tablets. The dissolution profiles of …

Objectives In-silico methods are a cost-effective possibility to support decision making at
different stages of the drug development process. Among the various computational …

The establishment of an in vitro–in vivo correlation (IVIVC) is considered the gold standard
to establish in vivo relevance of a dissolution method and to utilize dissolution data in the …

Nowadays, conducting discriminative dissolution experiments employing physiologically
based pharmacokinetic modeling (PBPK) or physiologically based biopharmaceutical …

Physiologically based biopharmaceutics modeling (PBBM) emphasizes the integration of
physicochemical properties of drug substance and formulation characteristics with system …