Several recently completed clinical trials in NASH patients have included fibrosis stage reductions in...
Impact of chemical structure on the in vitro hydrolysis of fatty esters of 2-ethylhexanoic acid or 2-ethylhexanol and extrapolation to the in vivo situation
Fatty esters of 2-ethylhexanoic acid (EHA) and 2-ethylhexanol (EH) are commonly used in cosmetics. Human liver and skin S9 and human plasma were used to determine the...
Mathematical Representation of Drug-Induced Crystal Nephropathy Using a Quantitative Systems Toxicology Approach
Drugs may cause crystal nephropathy by precipitating within kidney tubules or inducing...
Formulation development and optimization of taste-masked azithromycin oral suspension with ion exchange resins: Bioanalytical method development and validation, in vivo bioequivalence study, and in-silico PBPK modeling for the paediatric population
The study is based on preparing taste-masked oral suspension of azithromycin using ion exchange resins Kyron T135 and Doshion-P542 AB. The complexation...
Mathematical Modeling of Renal Sodium, Potassium, and Glucose Dynamics in Diabetic and Non-Diabetic Simulated Populations
Type 2 diabetic (T2D) patients often exhibit reduced systolic and diastolic functions, which can place them at...
Representation of Fibrosis Stage Within Mechanistic Model of Non-Alcoholic Fatty Liver Disease (NAFLD)/Non-Alchoholic Steatohepatitis (NASH) Aligns with Histologic Assessments
NAFLD encompasses a histological spectrum of liver pathophysiology ranging from steatosis to NASH and may result in cirrhosis and ultimately liver failure. A reduction in fibrosis stage, which...
Proof-of-concept that Variable Onset and Severity of T cell-mediated Drug-Induced Liver Injury is Reproduced in a Simulated Human Population
Idiosyncratic drug-induced liver injury (iDILI) is a rare, but often serious, adverse reaction that can compromise drug development. For some iDILI compounds¹, the...
Mechanistic modeling of drug products applied to the skin: A workshop summary report
The development of a generic drug product involves demonstrating that there is no significant difference in the rate and extent to which the active ingredient becomes...
Febrifugine dihydrochloride as a new oral chemotherapeutic agent against visceral leishmaniasis infection
Visceral leishmaniasis (VL) is the deadliest form of leishmaniasis without a safer treatment option.
Development of Mefenamic Acid-Soluplus ® amorphous dispersions via hot melt extrusion and in silico prediction of oral absorption
The objective of this study was to increase the solubility of Mefenamic Acid (MA), a BCS class II drug by formulating amorphous solid dispersions via Holt-Melt Extrusion.
Exploring a Bioequivalence Failure for Silodosin Products Due to Disintegrant Excipients
Some years ago, excipients were considered inert substances irrelevant in the absorption process. However, years of study have demonstrated that this belief is not always true.
Approaches of formulation bridging in support of orally administered drug product development
As a drug advances through the late stages of clinical development, formulation changes are common to meet clinical, manufacturing, and/or business needs.
Deciphering the immuno-pathological role of FLT, and evaluation of a novel dual inhibitor of topoisomerases and mutant-FLT3 for treating leukemia
Acute myeloid leukemia (AML) is a type of leukemia with an aggressive phenotype, that commonly occurs in adults and with disappointing treatment outcomes.
Simulations Plus and the University of Bath Awarded New FDA Grant
Project will focus on the development of a modeling & simulation framework to support an assessment of bioequivalence for locally-acting drugs in the gastrointestinal tract
Saliva Sampling in Therapeutic Drug Monitoring and Physiologically Based Pharmacokinetic Modeling: Review
Therapeutic drug monitoring investigations based on saliva samples can be utilized as an alternative to blood sampling for many advantages.
Use of Gastrointestinal Simulator, Mass Transport Analysis, and Absorption Simulation to Investigate the Impact of pH Modifiers in Mitigating Weakly Basic Drugs’ Performance Issues Related to Gastric pH: Palbociclib Case Study
It is well known that reduced gastric acidity, for example with concomitant administration of acid reducing agents, can result in variable pharmacokinetics and decreased...
Gustavo Mendes Lima Santos Joins the Simulations Plus Regulatory Fellowship
Ex-Anvisa General Manager will contribute to global regulatory strategies involving pharmacometrics
In vitro and in vivo evaluation of the main protease inhibitor FB2001 against SARS-CoV-2
FB2001 is a drug candidate that targets the main protease of SARS-CoV-2 via covalently binding to cysteine 145.
Predicting the correct dose in children: Role of computational Pediatric Physiological-based pharmacokinetics modeling tools
The pharmacokinetics (PKs) and safety of medications in particular groups can be predicted using the physiologically-based pharmacokinetic (PBPK) model.