Details

Autor(en) / Beteiligte

• Sugano, Kiyohiko
• Urban, Laszlo
• Wang, Jianling

Titel

Emerging Full Mechanistic Physiologically Based Modeling

Ist Teil von

• Predictive ADMET, 2014, p.189-209

Ort / Verlag

Hoboken, NJ, USA: John Wiley & Sons, Inc

Erscheinungsjahr

2014

Link zum Volltext

Quelle

Wiley Online Library All Obooks

Beschreibungen/Notizen

• The prediction of clinical pharmacokinetics (PK) from preclinical data is still challenging. Recently, physiologically based pharmacokinetics (PBPK) modeling became available for drug discovery and development. Currently, the paradigm of PBPK modeling is moving from semi‐empirical to full‐mechanistic ones. To move forward to a full‐mechanistic PBPK modeling paradigm, apparent in vitro data should be first decomposed to intrinsic PK parameters by applying a mechanistic mathematical model(s) to the in vitro data. Full‐mechanistic biopharmaceutical modeling has been extensively investigated during the last several years. The framework of theoretical equations is called the gastrointestinal unified theoretical (GUT) framework in this chapter. The full‐mechanistic models have been applied for other in vitro and in situ models such as the suspended hepatocyte assay and the brain perfusion assay. Population‐based prediction is another area where the full‐mechanistic approach has been anticipated to be successful.