Conference Call to be on Wednesday, April 9, at 4:15 PM ET

From Bench to Humans: Formulation Development of a Poorly Water Soluble Drug to Mitigate Food Effect
This study presents a formulation approach that was shown to mitigate the dramatic food effect observed for a BCS Class II drug. In vitro (dissolution), in vivo (dog), and in silico (GastroPlus®) models...

Application of Physiologically Based Absorption Modeling to Formulation Development of a Low Solubility, Low Permeability Weak Base: Mechanistic Investigation of Food Effect
Physiologically based pharmacokinetic (PBPK) modeling has been broadly used to facilitate drug development, hereby we developed a PBPK model to systematically investigate the...

A Case Study of In Silico Modelling of Ciprofloxacin Hydrochloride / Metallic Compound Interactions
With the development of physiologically based absorption models, there is an increased scientific and regulatory interest in in silico modelling and simulation of drug-drug and drug-food interactions.

Modelling the Absorption of Metformin with Patients Post Gastric Bypass Surgery
Gastric bypass surgery in obesity shortens the length of the small intestine, which can have a significant impact on drug absorption.

Physiologically based pharmacokinetic modeling framework for quantitative prediction of an herb-drug interaction
Herb-drug interaction predictions remain challenging. Physiologically based pharmacokinetic (PBPK) modeling was used to improve prediction accuracy of potential herb-drug interactions...

Computational Modeling of OATP1B1 Inhibitors
This poster was presented at the 2014 SOT meeting. It describes where the OATP1b1 data originated and the cutoff value. The model, including descriptors, is discussed.

Quantitative Modeling Uncovers a Potential Limitation in the Putative Mechanism of CCl4 Hepatotoxicity
Drug-induced liver injury (DILI) is one of the leading causes of drug development failures and drug withdrawals. DILIsym® is being developed to identify and mitigate DILI risk through in silico…

Differential effects of RUNX2 on the androgen receptor in prostate cancer: synergistic stimulation of a gene set exemplified by SNAI2 and subsequent invasiveness
Changes to androgen signaling during prostate carcinogenesis are associated with both inhibition of cellular differentiation and promotion of malignant phenotypes.

Simulations Plus Signs New Partnership Agreement in China
Research Institute for Liver Diseases to Offer Company’s Consulting Services

Where top-down meets bottom-up: Combined population PK (PopPk) and PBPK approaches to evaluate the impact of food and gastric pH on the pharmacokinetics of GDC-0941
The phosphoinositide 3-kinase (P13K) signaling pathway is deregulated in a wide variety of cancers. GDC-0941 is a potent and selective pan-inhibitor of class I P13K.

Diaromatic sulfur-containing ‘naphthenic’ acids in process waters
Polar organic compounds found in industrial process waters, particularly those originating from biodegraded petroleum residues, include ‘naphthenic acids’ (NA).

Simulations Plus Announces Success in COX-2/COX-1 Drug Design Project
Three of Four Molecules Hit Both Targets

Safety, tolerability, and pharmacokinetic evaluation of single- and multiple-ascending doses of a novel kappa opioid receptor antagonist LY2456302 and drug interaction with ethanol in healthy subjects
Accumulating evidence indicates that selective antagonism of kappa opioid receptors may provide therapeutic benefit in the treatment of major depressive disorder, anxiety disorders, and substance use disorders.

QbD and Biopharmaceutics – Use of Absorption Modeling
An informative online webinar that discusses the application of absorption modeling as a biopharmaceutics risk assessment tool to facilitate Quality by Design (QbD) arguments during formulation development.

Simulations Plus Reports Preliminary Revenues for Second Fiscal Quarter FY2014
Large Renewal Order Moves to Third Quarter, Still Posts Third Highest Quarterly Revenue

Simulations Plus Signs Research Collaboration Agreement with FDA
Company to Work with FDA on Mechanistic IVIVC Modeling

Semi-mechanistic modelling of the analgesic effect of gabapentin in the formalin-induced rat model of experimental pain
The formalin-induced rat model of nociception involves moderate continuous pain. Formalin-induced pain results in a typical repetitive flinching behaviour, which displays a biphasic pattern characterised by peaks of pain.

Imidazole aldoximes effective in assisting butyrylcholinesterase catalysis of organophosphate detoxification
Intoxication by organophosphate (OP) nerve agents and pesticides should be addressed by efficient, quickly deployable countermeasures such as antidotes reactivating acetylcholinesterase or scavenging the parent OP.

Neuroprotective Potential of Peroxisome Proliferator Activated Receptor-a Agonist in Cognitive Impairment in Parkinson’s Disease: Behavioral, Biochemical, and PBPK Profile
Parkinson’s disease (PD) is a common neurodegenerative disorder affecting 1% of the population by the age of 65 years and 4-5% of the population by the age of 85 years.