To demonstrate the use of mixture modeling in population PK analysis to predict drug concentrations for a subset of subjects with missing data for a key categorical covariate.

A Semi-mechanistic Approach to PK/PD Modeling of Complex Response Data: Bone Turnover Example for Odanacatib, a Cathepsin K Inhibitor
A variety of approaches can be taken to incorporate greater mechanistic understanding into PK/PD models, including a variety of bottom-up, middle-out, and top-down approaches. The osteoporosis field…

Black tea improves attention and self-reported alertness
Tea has previously been demonstrated to better help sustain alertness throughout the day in open-label studies.

Productivity is not a four letter word.
For me, anyway, the point of opinion writing is less to try to shape events, a presumptuous and foolhardy ambition at best, than to help stimulate debate and, from my particular perspective, try to explain why things got the way they are and what they might mean and where they might lead. My own idiosyncratic bent as a writer, no doubt a legacy of my years spent in the theater, is to look for a narrative in the many competing dramas unfolding on the national stage.
Frank Rich, New York Times

Astronomy picture of the day.
During the time that I was a clinical pharmacology fellow with Lewis Sheiner and Stuart Beal in San Francisco, the Voyager mission [1] was sending back incredible images of the moons of Jupiter and the rings of Saturn.

New to an Organization: Tools to Assess Projects and Teams
The complexity of project management and its value increase exponentially as the number and complexity of projects and interdisciplinary team participation increases.

Exposure–Response Analysis of Eslicarbazepine Acetate as Adjunctive Treatment of Patients With Partial-onset Seizures
Eslicarbazepine acetate (ESL) is a novel once-daily (QD) antiepileptic drug (AED) currently under clinical development in the US. ESL is rapidly and extensively metabolized to its major active metabolite…

Population Pharmacokinetics of Eslicarbazepine Acetate in Patients With Partial-onset Seizures
Eslicarbazepine acetate (ESL) is a novel once-daily antiepileptic drug (AED) currently under clinical development in the US. Following oral administration, ESL is rapidly and extensively metabolized…

Utility of Physiologically Based Absorption Modeling in Implementing Quality by Design in Drug Development
To implement Quality by Design (QbD) in drug development, scientists need tools that link drug products properties to in vivo performance

In Vitro-In Vivo Correlation for Gliclazide Immediate-Release Tablets Based on Mechanistic Absorption Simulation.
The aim of this study was to develop a drug-specific absorption model for gliclazide (GLK) using mechanistic gastrointestinal simulation technology (GIST) implemented...

Prediction of Oral Pharmacokinetics of cMet Kinase Inhibitors in Humans: Physiologically Based Pharmacokinetic Model versus Traditional One Compartment Model.
The objective of this study was to assess the physiologically based pharmacokinetic (PBPK) model for predicting plasma concentration-time profiles...

Computers win on Oscar night.
Did you watch the Oscars? A year ago, the 3D blockbuster, Avatar, was denied the Oscar for best film, which went to a low-budget war movie called The Hurt Locker. However, Avatar did win 3 Oscars in technical categories: Cinematography, Art Direction, and Visual Effects.

Simulations Plus Reports Preliminary Revenues for Second Fiscal Quarter of FY2011
String of Record Quarters Sustains Multi-Year Growth Trend

Simulations Plus (“SLP”) Releases ADMET Predictor Version 5.5
New Predictions Further Extend Best-in-Class Software

Simulations Plus (“SLP”) Launches MedChem Designer
Powerful Molecule Drawing Tool Added to World-Class Product Line

Use of structure-activity landscape index curves and curve integrals to evaluate the performance of multiple machine learning prediction models
Standard approaches to address the performance of predictive models that used common statistical measurements for the entire data set provide an overview of...

Simulations Plus to Collaborate with FDA to Develop Predictive Toxicity Models
Center for Food Safety and Applied Nutrition (CFSAN) to Provide Data

So, how cold was it?
We’ve had a cold winter so far in the USA, don’t you think? Snow in Alabama, a blizzard in Boston, another in Chicago, an ice storm in Dallas before the Super Bowl. . .Yep, it’s cold outside. But, take a look at this picture from 100 years ago. It’s hard to imagine how cold it had to have been to make Niagara Falls freeze over.

Simulations Plus Reports First Quarter FY2011 Financial Results
Pharmaceutical Software and Services Revenues Up 18%, Words+ Subsidiary Up 8.3%, Consolidated Earnings Up 32%, and EPS Up 34% from 1QFY10

Simulations Plus Sets Date for 1st Quarter 2011 Earnings Release and Conference Call
Conference Call to be on Friday, January 14, at 11:00 AM EST