Recommended for new users of PK-Sim as well as to anyone who needs to revive or complement existing knowledge about OSP.
Drug absorption from the gastrointestinal (GI) tract is a highly complex process dependent upon numerous factors including the physicochemical properties of the drug, characteristics of the formulation and interplay with the underlying anatomical and physiological properties of the GI tract. A physiologically based modeling approach provides a possibility to include these factors to predict oral drug absorption during drug product development as well as to establish links between in-vitro and in-vivo data to support establishment of clinically relevant drug product specifications.
This session is primarily recommended to those who want to increase their skills and experience in oral absorption modeling using PK Sim.
Session 3: The Qualification concept of OSP and its exemplary application to pediatric predictions with PK-Sim
The OSP (Re-)Qualification framework enables an automated validation of various scenarios (use-cases) supported by the OSP platform. This technical framework is used, for example, to release, in full confidence, a new version of the OSP Suite by verifying automatically that an ever-growing list of scenarios is performing as expected.
Pediatric population prediction is a common application of PBPK modeling. In this session this aspect will be addressed both as an example for the qualification process but also as to provide participants with knowledge and practical experience of how pediatric modeling is conducted in PK-Sim.
This session is recommended to those who want to gain insight in the OSP qualification concept and/or pediatric modeling using PK-Sim.
Local administration principles are commonly adopted for drugs with non-systemic pharmacological targets to maximize the effect by drug concentration at the site of action. Although this approach may be conceptually straightforward, the inherent difficulties in measuring local drug concentrations reduces the possibility for target exposure assessments and for making concentration-effect correlations. Similarly, it may be difficult to quantify the actual total dose administered, which is an important endpoint when developing pharmaceutical formulations and devices, if measurements such as bioavailability cannot be obtained. Models can, based on structural and drug related information as well as measurable proxy quantities, be applied to predict unmeasurable local exposure. Considerations should be taken to the circumstances under which the model has been evaluated and qualified to identify limitations (knowns-unknowns).
This session is primarily recommended for those interested in modeling of locally acting and locally administered drugs but also for those who are interested in model development and evaluation.