Applying Mechanistic Modeling to Predict Food Effects on Drugs: Approaches and Special Considerations

Applying Mechanistic Modeling to Predict Food Effects on Drugs: Approaches and Special Considerations

Software: GastroPlus®
Division: Simulations Plus

The focus of this webinar will be to discuss how physiological differences between fasted and fed states have been incorporated into mechanistic absorption (MAM) and physiologically based pharmacokinetic (PBPK) models to predict positive and negative food effects.

Exploratory Study on Lercanidipine Hydrochloride Polymorphism: pH-Dependent Solubility Behavior

Exploratory Study on Lercanidipine Hydrochloride Polymorphism: pH-Dependent Solubility Behavior

Software: GastroPlus®
Division: Simulations Plus

Based on the recent publication from AAPS PharmSci Tech, this 60-minute webinar will showcase an example of the use of GastroPlus® to assess the risk and pharmacokinetic relevance of different solubility and particle size between crystal forms of a poorly water-soluble antihypertensive drug, for diverse physiological conditions.

Modeling of Cyclosporine A-Induced Acute Kidney Injury with RENAsym®

Modeling of Cyclosporine A-Induced Acute Kidney Injury with RENAsym®

Conference: SOT
Software: RENAsym®
Division: DILIsym Services

Cyclosporine A (CsA) is an immunosuppressant commonly used to prevent organ rejection and can be used to treat other diseases such as...

Mechanistic modeling of biologics-induced liver injury (BILI) predicts hepatotoxicity of Tocilizumab through both on- and off-target effects

Mechanistic modeling of biologics-induced liver injury (BILI) predicts hepatotoxicity of Tocilizumab through both on- and off-target effects

Conference: SOT
Software: BIOLOGXsym
Division: DILIsym Services

Biologics address a range of unmet medical needs. However, there are
increasing numbers of BILI cases which slow therapeutic development...

PBK modelling of topical application and characterisation of the uncertainty of Cmax estimate: A case study approach

PBK modelling of topical application and characterisation of the uncertainty of Cmax estimate: A case study approach

Publication: Toxicol Appl Pharmacol
Software: GastroPlus®

Combined with in vitro bioactivity data, physiologically based kinetic (PBK) models has increasing applications in next generation risk assessment for animal-free safety decision...

Identification and characterization of urapidil stress degradation products by LC-Q-TOF-MS and NMR: Toxicity prediction of degradation products

Identification and characterization of urapidil stress degradation products by LC-Q-TOF-MS and NMR: Toxicity prediction of degradation products

Publication: J Pharm Biomed Anal
Software: ADMET Predictor®

Urapidil, an antihypertensive drug is subjected to various stress conditions (acidic, basic, neutral, oxidative and photolytic) as per ICH guidelines.