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Application of Permeability-limited Physiologically-based Pharmacokinetic Models: Part I—Digoxin Pharmacokinetic Incorporating P-glycoprotein-mediated Efflux Blog Post

A prerequisite for the prediction of the magnitude of P-glycoprotein (P-gp)-mediated drug-drug interactions between digoxin and P-gp inhibitors (e.g. verapamil and its metabolite norverapamil) or P-gp inducers (e.g. rifampicin) is…

Application of Permeability-limited Physiologically-based Pharmacokinetic Models: Part II—Prediction of P-glycoprotein Mediated Drug-drug Interactions with Digoxin Blog Post

Digoxin is the recommended substrate for assessment of P-glycoprotein (P-gp)-mediated drug-drug interactions (DDIs) in vivo. The overall aim of our study was to investigate the inhibitory potential of both verapamil…

Siponimod for Patients with Relapsing-remitting Multiple Sclerosis (BOLD): An Adaptive, Dose-ranging, Randomized, Phase 2 Study Blog Post

Siponimod is an oral selective modulator of sphingosine 1-phosphate receptor types 1 and type 5, with an elimination half-life leading to washout in 7 days. We aimed to determine the…

Accounting for Transporters in Renal Clearance: Towards a Mechanistic Kidney Model (Mech KiM) Blog Post

The impact of transporters in modulating the disposition of drugs in the liver and their passage across the gut wall has received much more attention than their role in renal…

Temporal Profile of Lymphocyte Counts and Relationship with Infections with Fingolimod Therapy Blog Post

Reduction in peripheral blood lymphocytes is an expected pharmacodynamic outcome of fingolimod therapy. The objective of this article is to evaluate lymphocyte dynamics during and after fingolimod therapy and assess…

Certara Enhances SYBYL-X Drug Design and Discovery Software Suite Blog Post

SYBYL-X 2.1 offers improved job control and increased QSAR accessibility ST. LOUIS, MO – Aug. 6, 2013 – Certara™, a leading provider of software and scientific consulting services to improve…

A Pilot Study Assessing the Bioavailability and Pharmacokinetics of Diazepam After Intranasal and Intravenous Administration in Healthy Volunteers Blog Post

Diazepam rectal gel (Diastat®) is the only FDA-approved product indicated for acute repetitive seizures. Despite its proven efficacy, most older children and adults object to this route of administration. As…

Pfizer Deploys Certara’s D360 for Scientific Data Access and Analysis Blog Post

Bio-IT World News Bulletin describes how Pfizer has adopted D360 as Pfizer’s core research platform. ST. LOUIS, MO – 2013 年 7 月 29 日 Certara™, a leading provider of software and scientific…

Clinical Trial Simulation to Inform Phase 2: Comparison of Concentrated vs. Distributed First-in-patient Study Designs in Psoriasis Blog Post

Clinical trial simulation (CTS) and model-based meta-analysis (MBMA) can increase our understanding of small, first-in-patient (FIP) trial design performance to inform Phase 2 decision making. In this work, we compared…

A Mechanistic Framework for In Vitro-In Vivo Extrapolation of Liver Membrane Transporters: Prediction of Drug-drug Interaction Between Rosuvastatin and Cyclosporine Blog Post

The interplay between liver metabolizing enzymes and transporters is a complex process involving system-related parameters such as liver blood perfusion as well as drug attributes including protein and lipid binding, ionization, relative magnitude of passive and active…

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