.Dissolution testing is a performance test for many dosage forms including tablets and capsules. The objective of this study was to evaluate if computer simulations can predict the in vitro dissolution of...
Eslicarbazepine Acetate Drug–Drug Interactions: Characterization Through a Model-Based Population Approach
Eslicarbazepine acetate (ESL) is a once-daily (QD) oral antiepileptic drug (AED), approved by the US Food and Drug Administration for the treatment of partial-onset seizures (POS) as monotherapy or...
Determining Pharmacological Selectivity of the Kappa Opioid Receptor Antagonist LY2456302 Using Pupillometry as a Translational Biomarker in Rat and Human
Selective kappa opioid receptor antagonism is a promising experimental strategy for the treatment of depression.
Concomitant intake of alcohol may increase the absorption of poorly soluble drugs
Ethanol can increase the solubility of poorly soluble and hence present a higher drug concentration in the gastrointestinal tract.
Rethinking Scientific Workflows
Developing a disease drug model is an intensely creative and collaborative effort. It requires the ability to assemble available knowledge and data and to gain a collective appreciation of important relationships. As this collaborative synthesis gets underway, pharmacometricians are charged with translating the ideas and hypotheses about diseases biology and drug pharmacology into mathematical equations. The equations are then coded into the control streams that, along with the data, become the basis for investigating the feasibility of various hypotheses.
Progressive Reporting and Model Based Drug Development
Over the years, our relationships with clients have deepened and Cognigen is often asked to begin working on projects at the earliest stages of development and to continue to refine a model as new data arrives from ongoing clinical development programs. Consequently, if a assets continues to show promise, we have the opportunity to provide modeling and simulation results at decision-making milestones over the lifecycle of clinical development. Typically, these activities culminate in a comprehensive synthesis of exposure-response relationships for efficacy and safety endpoints that are included in the regulatory submission.
Utilizing Physiologically Based Pharmacokinetic Modeling to Inform Formulation and Clinical Development for a Compound with pH-Dependent Solubility
ARRY-403 is a glucokinase activator developed for the treatment of diabetes. Less than dose-proportional exposure was observed during single ascending dose studies with ARRY-403.
Simulations Plus Reports First Quarter FY2015 Financial Results
Final report of first quarter financial results after Cognigen merger; net revenues up 54%; gross profit increased 41%
Physiologically based pharmacokinetic modelling in drug discovery and development: A pharmaceutical industry perspective
The application of physiologically based pharmacokinetic (PBPK) modeling has developed rapidly within the pharmaceutical industry and is becoming an integral part of drug discovery and development.
Simulations Plus Sets Date for 1st Quarter 2015 Earnings Release and Conference Call
Conference Call to be on Wednesday, January 14, at 4:15 PM ET
Comparison of in silico tools for evaluating rat oral acute toxicity
Different in silico models have been developed and implemented for the evaluation of mammalian acute toxicity, exploring acute oral toxicity data expressed as median lethal dose (LD(50)).
The potency–insolubility conundrum in pharmaceuticals: Mechanism and solution for hepatitis C protease inhibitors
As compounds are optimized for greater potency during pharmaceutical discovery, their aqueous solubility often decreases, making them less viable as orally-administered drugs.
The potency-insolubility conundrum in pharmaceuticals: Mechanism and solution for hepatitis C protease inhibitors
As compounds are optimized for greater potency during pharmaceutical discovery, their aqueous solubility often decreases, making them less viable as orally-administered drugs.
Relationships between the antidotal efficacy and structure, PK/PD parameters and bio-relevant molecular descriptors of AChE reactivating oximes: inclusion and integration to biopharmaceutical classification systems
The therapeutic outcome of oximes used as reactivators of phosphorylated human acetylcholinesterase (AChE) is influenced, among other factors, by their biological distribution, their in vivo ability...
In vitro-in vivo correlations: general concepts, methodologies and regulatory applications
The major objective of in vitro-in vivo correlations is to be able to use in vitro data to predict in vivo performance serving as a surrogate for an in vivo bioavailability test and to support biowaivers.
Chromatographic lipophilicity as a predictor of antiproliferative activity of 17-picolyl and 17-picolinylidene androstane derivatives toward prostate cancer
Lipophilicity is a molecular parameter widely used in estimation of biological and environmental behavior of many substances (1-3).
Nonclinical and pharmacokinetic assessments to evaluate the potential of tedizolid and linezolid to affect mitochondrial function
Prolonged treatment with the oxazolidinone linezolid is associated with myelosuppression, lactic acidosis, and neuropathies, toxicities likely caused by impairment of mitochondrial protein synthesis (MPS). To evaluate the potential of the novel oxazolidinone tedizolid...
Predicting drug-drug interactions involving multiple mechanisms using physiologically based pharmacokinetic modeling: A case study with ruxolitinib
Physiologically based pharmacokinetic modeling was applied to characterize the potential drug–drug interactions for ruxolitinib.