The aim of this tutorial is to show how to develop a pharmacokinetic-pharmacodynamic (PKPD) model.
Physiologically Based Pharmacokinetic Model for Voriconazole and Prediction of its Interactions with Midazolam and Alfentanil
Voriconazole (formerly known as UK-109,496), is a second-generation triazole antifungal agent widely used in the treatment of invasive fungal infections.
Exploring Clinical Relevance of Dissolution Testing by Physiologically Based Biopharmaceutics Modeling (PBBM)
In vitro dissolution testing, if reflective of in vivo drug release/absorption, is considered a surrogate for in vivo drug performance.
Mechanistic Insights into Drug-Induced Liver Injury for Macrolide Antibiotics using Quantitative Systems Toxicology Modeling
DILIsym Services Is Using QSP and QST Modeling to Predict Efficacy and Safety of Drugs in Development
Predicting Shrinkage of Individual Parameters in More Complex NLME Models Using Bayesian Fisher Information Matrix
When data are sparse, parameters derived from a non-linear mixed effects model analysis...
Simulations Plus Sets Date for 4th Quarter and Fiscal Year 2019 Earnings Release and Conference Call
Conference Call to be on Wednesday, November 13, 2019, at 4:15 PM ET
Development of Drugs to Treat NAFLD/NASH using Quantitative Systems Pharmacology Modeling
This session will provide scientific background and overview of the application of quantitative systems pharmacology (QSP) modeling in drug development to treat NALFD/NASH
Integrating In Vitro Testing and Physiologically-Based Pharmacokinetic (PBPK) Modelling for Chemical Liver Toxicity Assessment – a Case Study of Troglitazone
In vitro to in vivo extrapolation (IVIVE) for next-generation risk assessment (NGRA) of chemicals requires computational modeling and faces unique challenges.
Combination of Gemcitabine with Cell-Penetrating Peptides: A Pharmacokinetic Approach Using In Silico Tools
Gemcitabine is an anticancer drug used to treat a wide range of solid tumors and is a first line treatment for pancreatic cancer.
Toxicity Assessment of Herbal Medicine Using Zebrafish Embryos: A Systematic Review
Herbal remedies have been practiced by humans over centuries and therefore possess time-proven safety.
Synergy Between Two Mechanisms of Action Contributes to Species Differences in the Liver Safety Profile for PF-04895162
The Purpose is to better understand the mechanisms underlying the apparent species differences, between rat and human, when evaluating the liver safety of compound PF-04895162.
Development of a Physiologically Based Pharmacokinetic (PBPK) Model for Intra-articular Delivery
Understanding local concentrations in intra-articular tissues and fluids such as cartilage, synovial membrane, and synovial fluid are a valuable tool to predict potential...
Efavirenz Physiologically Based Pharmacokinetic Model Development and Validation as a Moderate CYP3A4 Inducer for Drug-Drug Interaction Predictions
Efavirenz is an antiretroviral medication used to treat and prevent HIV/AIDS.
The Effect of the Local Tissue Response on the Pharmacokinetics of Long-Acting Injectable Formulations
Modeling consequences of localized chronic inflammation in tissue on drug diffusion and exposure caused by prolonged therapy with long-acting formulations.
Different Perspectives – Informing Drug Development Decision Making Through Complementary M&S Approaches
Although fundamental principles are different between PBPK and population PK approaches, both techniques have been used to study drug disposition during drug development.
Quantitative Systems Toxicology Approaches to Understand and Predict Drug-Induced Liver Injury
The DILI-sim Initiative is a public-private partnership that has applied quantitative systems toxicology modeling to develop software (DILIsym) that has improved mechanistic understanding of DILI.
Mechanistic Dissolution Modeling of a Poorly Soluble Drug; an Evaluation of Formulation Influence and Simulation Parameters for Enhancing Predictive Capability
In early drug development, the selection of a formulation platform and decisions on formulation strategies have to be made...
Case study: PK model development for a multi-dose study (Maryland 2)
The aim of this tutorial is to develop a population PK model for a multiple dosing trial study of a hypothetical test drug used in the...
The development of a population physiologically based pharmacokinetic model for mycophenolic mofetil and mycophenolic acid in humans using data from plasma, saliva, and kidney tissue
Mycophenolic acid (MPA) is used widely to prevent graft rejection in kidney‐transplant patients.
Prediction of Oral Bioavailability in Rats: Transferring Insights from in Vitro Correlations to (Deep) Machine Learning Models Using in Silico Model Outputs and Chemical Structure Parameters
Oral administration of drug products is a strict requirement in many medical indications.