San Diego, California

Extending MAM/PBPK modeling approaches to predict non‐oral delivery of drugs 

FREE! The focus of this 1‐day workshop will be to discuss development of MAM/PBPK models for major non oral administration routes (nasal/pulmonary, dermal, ocular, and oral cavity) and how they can be applied to address key development questions. A combination of presentations and interactive examples using the GastroPlus™ PBPK modeling platform will illustrate how to parameterize baseline models and, once validated, how they can be deployed to predict FIH exposure and simulate the impact of formulation changes on local and systemic exposure to identify clinically relevant specifications.

Please note – this FREE workshop is open to anyone – registration to the ACoP conference is not required. You will need to register your attendance to the workshop below.
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Using DILIsym to Assess the Liver Safety of Drugs and Drug Candidates

FREE! This 1 day hands‐on workshop provides a working knowledge of the basic theories and application of state‐of‐the‐art quantitative system toxicology (QST) modeling and simulation software (DILIsym) for the analysis of the potential for drugs and drug candidates to cause drug‐induced liver injury (DILI), or for the investigation of mechanisms involved in a documented DILI event. A combination of presentations and interactive examples using DILIsym will illustrate how to gather the appropriate in vitro toxicity data, derive DILIsym related toxicity parameters, conduct simulations of expected outcomes and analyze results for impacting decisions. This is a beginner’s course ‐prior experience with DILIsym is not required.
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The DILIsym® 3-Day Training Workshop

This three-day, hands-on course provides a working knowledge of the basic theories and application of state-of-the-art quantitative system toxicology (QST) modeling and simulation software (DILIsym®) for the analysis of the potential for drugs and drug candidates to cause drug-induced liver injury (DILI), or for the investigation of mechanisms involved in a documented DILI event. A combination of presentations and interactive examples using DILIsym will illustrate how to gather the appropriate in vitro toxicity data, derive DILIsym related toxicity parameters, conduct simulations of expected outcomes and analyze results for impacting decisions.

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The Introductory GastroPlus™ Simulation and Modeling Workshop

This three-day, hands-on course provides a working knowledge of the basic theories and application of state-of-the-art PBPK simulation and modeling software for the analysis of drug dissolution and absorption, coupled with the resulting pharmacokinetics and pharmacodynamics. A combination of presentations and interactive examples, taken from actual industry experience and using GastroPlus, illustrate how to recognize and deal with the multiple interacting phenomena that affect the absorption, PBPK/PD and DDIs of particular drugs and dosage forms.

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