In-clinic venous dried blood spot (DBS) pharmacokinetic (PK) sampling was incorporated into two phase 3 studies of verubecestat for
Physiologically Based Biopharmaceutics Model of Vildagliptin Modified Release (MR) Tablets to Predict In Vivo Performance and Establish Clinically Relevant Dissolution Specifications
The objective of the study was to predict pharmacokinetic (PK) and pharmacodynamic (PD) parameters of matrix-based modified release (MR) drug product of vildagliptin.
NOMINATING COMMITTEE CHARTER 2022
Revision: March 31, 2022
Purpose:
The Board of Directors has established a Nominating & Corporate Governance Committee (the “Committee”) whose purpose is to seek and nominate qualified candidates for election or appointment to Simulation Plus’s Board of Directors.
Sputum lipoarabinomannan (LAM) as a biomarker to determine sputum mycobacterial load: exploratory and model-based analyses of integrated data from four cohorts
Despite the high global disease burden of tuberculosis (TB), the disease caused by Mycobacterium tuberculosis (Mtb) infection, novel treatments remain an urgent medical need. Development efforts continue to
Design of Dual COX-2 and 5-LOX Inhibitors with Iron-Chelating Properties Using Structure-Based and Ligand-Based Methods
Background: Inflammation is a critical component of many disease progressions, such as malignancy, cardiovascular and rheumatic diseases.
PBK modelling of topical application and characterisation of the uncertainty of Cmax estimate: A case study approach
Combined with in vitro bioactivity data, physiologically based kinetic (PBK) models has increasing applications in next generation risk assessment for animal-free safety...
Applying Mechanistic Modeling to Predict Food Effects on Drugs: Approaches and Special Considerations
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
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.
An IQ Consortium Perspective on Connecting Dissolution Methods to In Vivo Performance: Analysis of an Industrial Database and Case Studies to Propose a Workflow
Assessment of bioperformance to inform formulation selection and development decisions is an important aspect of drug development.
Simulations Plus Receives $1.7 Million Grant for BIOLOGXsym™ Macromolecule Safety Software
SLP will partner with the University of Pittsburgh and its Liver-on-a-Chip platform
Physiologically based pharmacokinetic (PBPK) simulations and modeling of botanical constituents
Botanicals have broad use as traditional medicines, natural health products, and dietary supplements around the world.
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Modeling of Cyclosporine A-Induced Acute Kidney Injury with RENAsym®
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
Biologics address a range of unmet medical needs. However, there are
increasing numbers of BILI cases which slow therapeutic development...
Simulating Multidrug Resistance Protein 3 (MDR3) Inhibition-Mediated Cholestatic Liver Injury Using DILIsym X, a Quantitative Systems Toxicology (QST) Modeling Platform
Inhibition of efflux transporters located on the canalicular membrane of hepatocytes is an important mechanism of cholestatic liver injury, which is...
Quantitative Systems Toxicology (QST) Modeling of Cimaglermin Alfa (GGF2) Hepatotoxicity Shows the Potential of BIOLOGXsym to Predict Biologics-Induced Liver Injury (BILI)
Biologics continue to address various unmet medical needs, but the occurrence of BILI can terminate clinical...
Modeling of Indinavir-Induced Crystal Nephropathy in RENAsym®
Indinavir, a protease inhibitor used to treat patients with HIV/AIDS, is known to induce crystal nephropathy. This is...
Evaluating Nephrotoxicity of Cisplatin in Rats with RENAsym, a Mechanistic Model of Drug-Induced Acute Kidney Injury
Acute kidney injury (AKI) is often initiated by cellular toxicity of proximal tubule epithelial cells (PTEC) when...
PBK modelling of topical application and characterisation of the uncertainty of Cmax estimate: A case study approach
Combined with in vitro bioactivity data, physiologically based kinetic (PBK) models has increasing applications in next generation risk assessment for animal-free safety decision...