The objective of the study was to develop a QbD based orodispersible Nitazoxanide 200 mg tablets its in-silico PBPK modeling. The central composite design was applied...
Model-Informed drug development of gastroretentive release systems for sildenafil citrate
Gastroretentive drug delivery systems (GRDDS) are modified-release dosage forms designed to prolong their residence time in the upper gastrointestinal tract...
Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspective
Model‐informed drug development (MIDD) approaches receive wide regulatory acceptance in the European Medicines Agency (EMA) to support new drug development.
Attenuations in adiponectin production over time restrict simulated efficacy for pegbelfermin in F3 NASH patients
Patients with non-alcoholic steatohepatitis (NASH) and fibrosis do not currently have options for...
Greater efficacy predicted for FGR1/beta-klotho receptor agonists that achieve 60% or greater increases in serum adiponectin
The FGFR1/beta-klotho receptor (FGFR1/KLB) in adipose has been demonstrated to be a...
Reduction of daily moderate alcohol intake predicted to decrease fibrosis stage in patients with non-alcholic steatohepatitis
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