Software based approaches for drug designing and development: A systematic review on commonly used software and its applications.

Software based approaches for drug designing and development: A systematic review on commonly used software and its applications.

Publication: Bulletin of the Faculty of Pharmacy, Cairo University

Drug discovery include drug designing and development, is a multifarious and expensive endeavor, where least number of drugs that pass the clinical trials makes it to market.

Phase 1 and pharmacokinetic study of LY3007113, a p38 MAPK inhibitor, in patients with advanced cancer

Phase 1 and pharmacokinetic study of LY3007113, a p38 MAPK inhibitor, in patients with advanced cancer

Publication: Investigational New Drugs
Division: Simulations Plus

Background The signaling protein p38 mitogen-activated protein kinase (MAPK) regulates the tumor cell microenvironment, modulating cell survival, migration, and invasion.

2017 White Paper on recent issues in bioanalysis: aren’t BMV guidance/guidelines ‘Scientific’? (Part 1 – LCMS: small molecules, peptides and small molecule biomarkers)

2017 White Paper on recent issues in bioanalysis: aren’t BMV guidance/guidelines ‘Scientific’? (Part 1 – LCMS: small molecules, peptides and small molecule biomarkers)

Publication: Bioanalysis
Division: Simulations Plus

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.

Modeling of Active Transport and Metabolism for Hepatocyte Assays with Application of In Vitro to In Vivo Extrapolation (IVIVE)

Modeling of Active Transport and Metabolism for Hepatocyte Assays with Application of In Vitro to In Vivo Extrapolation (IVIVE)

Conference: AAPS
Software: MembranePlus™

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

Development of In Vitro-In Vivo Correlation for Long Acting Injectable Microsphere Formulations

Conference: AAPS
Software: GastroPlus®
Division: Simulations Plus

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

Application of Physiologically Based Pharmacokinetic (PBPK) Models in Predicting Drug Pharmacokinetics for Different Ethnic Groups

Conference: AAPS
Software: GastroPlus®
Division: Simulations Plus

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.

Ribociclib Bioavailability Is Not Affected by Gastric pH Changes or Food Intake: In Silico and Clinical Evaluations.

Ribociclib Bioavailability Is Not Affected by Gastric pH Changes or Food Intake: In Silico and Clinical Evaluations.

Publication: Clin Pharmacol Ther
Software: GastroPlus®

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...

Intrinsic dissolution simulation of highly and poorly soluble drugs for BCS solubility classification

Intrinsic dissolution simulation of highly and poorly soluble drugs for BCS solubility classification

Publication: Dissolut Technol
Software: DDDPlus™

Intrinsic dissolution testing allows characterizing drug substances through its dissolution rate when exposed to a specified surface area in a specific dissolution media.