Fiscal Year Pharmaceutical Software and Services Up 14.7%, EPS Up 29.3%

Simulations Plus Sets Date for 4th Quarter and Fiscal Year 2011 Earnings Release and Conference Call
Conference Call to be on Thursday, December 1, 2011 at 4:30 PM EST

Simulations Plus Signs Stock Purchase Agreement for Sale of Words+ Subsidiary
Prentke Romich Company to Acquire Subsidiary and Continue Operations

Effect of gastric pH on the pharmacokinetics of a BCS Class II compound in dogs: Utilization of an artificial stomach and duodenum dissolution model and GastroPlus™ simulations to predict absorption
Dogs are one of the most commonly used non-rodent species in toxicology studies and are known to have basal stomach pH ranging from 2 to 7 in the fasted state.

Application of PBPK modelling in drug discovery and development at Pfizer
Early prediction of human pharmacokinetics (PK) and drug–drug interactions (DDI) in drug discovery and development allows for more informed decision making.

Physiologically-Based Pharmacokinetic (PBPK) Model for Prediction of Midazolam Pharmacokinetics After Intranasal Administration in Children
To predict midazolam absorption and pharmacokinetics (PK) after intranasal (i.n.) administration in young children. The absorption and PK of midazolam were simulated using GastroPlus™. The program’s…

Physiologically-Based Pharmacokinetic (PBPK) Models for Prediction of Saquinavir Effect on Midazolam Pharmacokinetics
Physiologically-based pharmacokinetic (PBPK) models for prediction of saquinavir effect on midazolam pharmacokinetics
Viera Lukacova, Walter S. Woltosz, Michael B. Bolger

Translating Disposition of Sotalol from Healthy Adults to Predict Its Behavior in Pediatric and Adult Subjects with Enhanced and Diminished Renal Clearance
To extend a physiologically based pharmacokinetic (PBPK) model of sotalol developed in healthy adults to predict its behavior in pediatric subjects and adults with varying degrees of renal clearance…

A Pharmacokinetic and Safety Evaluation of Single Oral Doses of Eszopiclone in Pediatric Subjects from 6 to 17 Years of Age with Attention Deficit Hyperactivity Disorder and Insomnia
Eszopiclone is a single-isomer, nonbenzodiazepine, cyclopyrrolone agent that has demonstrated efficacy with both polysomnography (PSG) and patient-reported measures in non-elderly adults with chronic primary…

It’s not gloom and doom if it helps to frame the problem.
I know, I know — you don’t want to read another doom and gloom blog. But, in a recent article in the National Review* (link is no longer available), Peter Thiel does an excellent job of linking the desperate necessity of advancements in technology and science with the broader societal crises we are now experiencing. Thiel posits that there is a mistaken, but nearly universal, background assumption about easy progress that underlies our unwillingness to tackle difficult problems.

Grouping Pharmacokinetic Profiles Using Kohonen Self-Organizing Maps
The shapes of plasma concentration versus time (Cp-time) profiles from large clinical trials are often highly variable, even in well-controlled trials involving homogeneous cohorts.

Transporter-Based in vitro-in vivo Extrapolation (IVIVE)
The use of in vitro data to predict the pharmacokinetics (PK) of drugs whose disposition is mediated by transporters is complicated due to unknown transporter expression levels in individual tissues both…

The role of predictive biopharmaceutical modeling and simulation in drug development and regulatory evaluation
Advances in predicting in vivo performance of drug products has the potential to change how drug products are developed and reviewed.

A sequence within the varicella-zoster virus (VZV) OriS is a negative regulator of DNA replication and is bound by a protein complex containing the VZV ORF29 protein
The architecture of the varicella-zoster virus (VZV) origin of DNA replication (OriS) differs significantly from that of the herpes simplex virus (HSV) DNA replication origin.

Simulations Plus Completes Molecule Design Phase, Issues RFQs for Molecule Synthesis
Company Uses Proprietary Software Tools to Design New Drug-like Molecules for Resistant Malaria Parasite

Pharmacokinetic (PK) And Pharmacodynamic (PD) Modeling Of Subcutaneous (Sc) Ly2189102, A Neutralizing IL-1 Beta Antibody, In Patients With Type 2 Diabetes Mellitus
LY2189102, a humanized neutralizing IL-1β antibody, was studied in type 2 diabetes mellitus (T2DM) patients with C-reactive protein (CRP) ≥ 2 mg/L, who received weekly subcutaneous doses of LY2189102…

Simulations Plus Reports Preliminary Revenues for Fourth Fiscal Quarter and FY2011
Pharmaceutical Software and Services Revenues Increase 6.9% for 4th Quarter, up 14.7% for the Fiscal Year

Development of a physiologically based model for oseltamivir and simulation of pharmacokinetics in neonates and infants
Physiologically based pharmacokinetic (PBPK) modelling can assist in the development of drug therapies and regimens suitable for challenging patient populations such as very young children.