GastroPlus^® Workshop Tokyo 2023 Agenda

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GastroPlus^® Introductory Workshop − November 13^th - 15^th, 2023

Day 1:

• Introduction
• Solubility/Dissolution/Precipitation
• Permeability/Absorption
• PBPK Modeling

Day 2:

• PBPK Modeling-continue
• Nonlinear Metabolism/Carrier-Mediated Transport
• Compartmental PK
• DDI Predictions
• Q&A

Day 3:

• PK/PD Modeling
• Mechanistic IVIVCs & Virtual BE
• Biologics
• Dermal/Pulmonary Overview
• Q&A

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GastroPlus^® Advanced DMPK & Clinical Pharmacology Workshop

− November 16^th - 17^th, 2023

Day 1:

• Intro to PBPK: First-in-human predictions - hepatic & renal clearance
• Transporter-based IVIVE
• Enterohepatic circulation/metabolite tracking modeling

Day 2:

• Special Populations
• Pediatric population predictions
• Pregnancy modeling
• Disease state modeling
• DDI predictions (dynamic/steady state), with focus on auto-induction
• PBPK/PD modeling
• Q&A

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GastroPlus^® Advanced Pharmaceutical Development Workshop

− November 15^th - 16^th, 2023

Day 1:

• Common ion effect on solubility/dissolution/precipitation
• Salt selection/screening and the impact on precipitation kinetics
• Proper use of in vitro dissolution data, especially as it relates to the Z-factor model
• Optimizing formulation (release rate) to hit a therapeutic concentration window

Day 2:

• Positive/negative food effect, with focus on issues related to stomach emptying
• Mechanistic deconvolutions and integration with DDDPlus™
• Virtual bioequivalence trials
• Q&A