Oxycodone is an opioid analgesic with several pharmacologically active metabolites and relatively narrow therapeutic index.
Application of a hemodialysis clearance prediction model using quantitative structure‐pharmacokinetic relationship analysis
Hemodialysis (HD) is a method used to remove biogenic substances or blood components that cause disease and some drugs...
Simulations Plus Reports Record First Quarter FY2020 Financial Results
First quarter net revenues of $9.4 million reflecting 24.8% year-over-year growth
Feature of the week #72: Display and informativeness of the BLQ data in the plots
To display BLQ data in the plot, Monolix uses simulated BLQ values.
An industrial approach towards solid dosage development for first-in-human studies: Application of predictive science and lean principles
Tablet development is challenging during early clinical phases of drug discovery because of dose uncertainty, limited active pharmaceutical ingredient availability, and short lead times.
Quantitative systems toxicology (QST) reproduces species differences in PF‐04895162 liver safety due to combined mitochondrial and bile acid toxicity
Many compounds that appear promising in preclinical species, fail in human clinical trials due to safety concerns.
Bridging inhaled aerosol dosimetry to physiologically based pharmacokinetic modeling for toxicological assessment: nicotine delivery systems and beyond
One of the challenges for toxicological assessment of inhaled aerosols is to accurately predict their deposited and absorbed dose.
Comparison of the Hepatotoxic Potential of Two Treatments for Autosomal-Dominant Polycystic Kidney DiseaseUsing Quantitative Systems Toxicology Modeling
Autosomal-dominant polycystic kidney disease (ADPKD) is an orphan disease with few current treatment options.
Physiologically Based Pharmacokinetic Model to Support Ophthalmic Suspension Product Development
FDA’s Orange Book lists 17 currently marketed active pharmaceutical ingredients (API) formulated within ophthalmic suspensions in which a majority has 90% or more of the API undissolved.
In Vitro Dissolution and in Silico Modeling Shortcuts in Bioequivalence Testing
To review in vitro testing and simulation platforms that are in current use to predict in vivo performances of generic products as well as other situations to provide evidence for biowaiver and support drug formulations development.
The Significance of Utilizing In Vitro Transfer Model and Media Selection to Study the Dissolution Performance of Weak Ionizable Bases: Investigation Using Saquinavir as a Model Drug
This study investigated the dissolution behavior of BCS class II ionizable weak base Saquinavir and its mesylate salt in the multi-compartment transfer setup employing different composition of dissolution media.
The Evolving Druggability and Developability Space: Chemically Modified New Modalities and Emerging Small Molecules
The druggability and developability space is rapidly evolving in the post-genomic era.
Simulations Plus Sets Date for First Quarter Fiscal Year 2020 Earnings Release and Conference Call
Conference Call to be on Thursday, January 9, 2020, at 4:15 PM ET
Second basic pKa: An overlooked parameter in predicting phospholipidosis-inducing potential of diamines
In this paper, we present the phospholipidosis-inducing potential (PLIP) of forty fragment-sized diamines derived from N-benzyl-4...
An in vitro toolbox to accelerate anti-malarial drug discovery and development
Modelling and simulation are being increasingly utilized to support the discovery and development of new anti-malarial drugs.
Integrated phytochemical analysis based on UHPLC-LTQ–Orbitrap and network pharmacology approaches to explore the potential mechanism of Lycium ruthenicum Murr. for ameliorating Alzheimer’s disease
Based on compelling experimental and clinical evidence, the fruit of Lycium ruthenicum Murr. (LRM), a unique traditional Tibetan medicine...
Allosteric regulation of protein 14-3-3ζ scaffold by small-molecule editing modulates histone H3 post-translational modifications
Histone post-translational modifications (PTMs) are involved in various biological processes such as transcriptional...
Relationship between plasma concentrations and clinical effects of cariprazine in patients with schizophrenia or bipolar mania
Population pharmacokinetic/pharmacodynamic modeling (via NONMEM) was used to describe longitudinal exposure-response...