2017 White Paper on recent issues in bioanalysis: aren’t BMV guidance/guidelines ‘Scientific’? (Part 1 – LCMS: small molecules, peptides and small molecule biomarkers)
The 2017 11th Workshop on Recent Issues in Bioanalysis (11th WRIB) took place in Los Angeles/Universal City, California from 3 April 2017 to 7 April 2017 with participation of close to 750 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide.
A cross-species translational pharmacokinetic-pharmacodynamic evaluation of core bodytemperature reduction by the TRPM8 blocker PF-05105679.
PF-05105679 is a moderately potent TRPM8 blocker which has been evaluated for the treatment of cold pain sensitivity.
Modeling of Active Transport and Metabolism for Hepatocyte Assays with Application of In Vitro to In Vivo Extrapolation (IVIVE)
Sandwich and suspended hepatocyte cultures are routinely used to assess either active transport and/or metabolism of drug molecules.
Development of In Vitro-In Vivo Correlation for Long Acting Injectable Microsphere Formulations
The concept of in vitro-in vivo correlations (IVIVCs) for long-acting injectable (LAI) microsphere formulations has gained more significance in the past decade.
Application of Physiologically Based Pharmacokinetic (PBPK) Models in Predicting Drug Pharmacokinetics for Different Ethnic Groups
The purpose of this study was to evaluate the ability of PBPK models to predict the pharmacokinects (PK) of different compounds in two ethnic groups, Caucasian and Chinese.
Simulations Plus Reports FY2017 and Fourth Quarter FY2017 Financial Results
Full Fiscal Year Pharmaceutical Software and Services Revenues Up 20.9%;
Earnings per share of $0.33, up 14.9% over prior year
Ribociclib Bioavailability Is Not Affected by Gastric pH Changes or Food Intake: In Silico and Clinical Evaluations.
Ribociclib (KISQALI®), a cyclin-dependent kinase 4/6 inhibitor approved for the first-line treatment of HR+/HER2– advanced breast cancer with an aromatase inhibitor, is administered with...
ADMET Predictor 8.5 Release Notes
Many major enhancements have been made throughout ADMET Predictor for this release.
Intrinsic dissolution simulation of highly and poorly soluble drugs for BCS solubility classification
Intrinsic dissolution testing allows characterizing drug substances through its dissolution rate when exposed to a specified surface area in a specific dissolution media.
ADMET Predictor™ v8.5 Webinar – Discover ‘Discovery PBPK’: Efficiently use PBPK modeling to drive lead selection & optimization
In this video, Michael Lawless discusses how to efficiently screen large compound libraries in minutes based on predicted in vivo fraction absorbed (Fa%) or oral bioavailability (F%) in virtual rats...
GastroPlus® ADMET Predictor Module
This video shows features available in MedChem Designer™ that are available for users that license the ADMET Predictor™ module within GastroPlus™.
Simulations Plus Sets Date for 4th Quarter and Fiscal Year 2017 Earnings Release and Conference Call
Conference Call to be on Tuesday, November 14, at 4:15 PM ET
Robust Uncertainty Estimates for Unbalanced Data Sets
Mathematical models of quantitative structure-activity relationships (QSARs) play a key role in qualifying synthesis ideas, drug candidates and leads.
Combining “Bottom-up” and “Top-down” Approaches to Assess the Impact of Food and Gastric pH on Pictilisib (GDC-0941) Pharmacokinetics
Pictilisib, a weakly basic compound, is an orally administered, potent, and selective pan-inhibitor of phosphatidylinositol 3-kinases for oncology indications.
Investigating Oral Absorption of Carbamazepine in Pediatric Populations
Prediction of the pharmacokinetics of orally administered drugs in children is of importance to optimize the efficacy and safety of pediatricmedicines.