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ACoP 11

October 3 - October 7

October 3, 2020 – October 7, 2020


PBPK Workshop

Applying PBBM/PBPK Modeling to Predict Absorption-Related Drug-Drug Interactions: Approaches and Special Considerations

October 3, 2020

8:00 AM

Gaylord Rockies Resort & Convention Center near Denver, in Aurora, Colorado

Proposed Schedule and topic outline:

The focus of this ½-day workshop will be to discuss how the co-administration of proton pump inhibitors (PPIs) and acid-reducing agents (ARAs) impact gastrointestinal physiology and have been incorporated into physiologically based biopharmaceutics (PBBM) / pharmacokinetic (PBPK) models to predict absorption-related DDIs. A combination of presentations and interactive examples using the GastroPlus® PBBM/PBPK modeling platform will illustrate how to parameterize baseline models for several drugs and, once validated, apply them to predict the changes in absorption and systemic exposure when drug is co-administered with PPIs/ARAs. Proposed workflows to inform clinical development and regulatory interactions will be discussed, and gaps in the current methods will also be explored.

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QSP Workshop

QSP Modeling of Fibrosis Across Diseases

October 8, 2020

1:30 PM

Gaylord Rockies Resort & Convention Center near Denver, in Aurora, Colorado.

Proposed Schedule and topic outline:

Fibrosis is a critical aspect of many diseases that are yet untreated with adequate pharmaceutical intervention. This half day workshop covers the basic theories and applications of quantitative systems pharmacology (QSP) modeling focused on fibrosis, including special emphasis on the slow developing nature of the etiology and the upstream, downstream, and clinical outcome/biomarker indicators that must be considered. Fibrosis of the liver via NASH and fibrosis of the lung as with idiopathic pulmonary fibrosis (IPF) will be used as key examples. The NAFLDsym® and IPFsym® software tools will serve as example model platforms. Presentations, demonstrations, and interactive examples will illustrate typical data inputs utilized and address how to run simulations of expected outcomes and analyze results for impacting decisions. This course is useful for all individuals interested in these fields – prior QSP experience is not required, nor is a deep existing knowledge of fibrosis. Attendees will understand the following important aspects of modeling fibrosis: key components of the pathophysiology, including initiation and stimulation of collagen production via fibroblasts and/or stellate cells, interaction with the immune system, resolution of fibrosis, and biomarkers; examples of targets represented for in silico evaluation; and stratification of simulated populations to address a planned or possible clinical study. The process of representing fibrosis across different diseases and organs will also be discussed.

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Details

Start:
October 3
End:
October 7

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