Costs, scientific and ethical concerns related to animal tests for regulatory decision-makinghave stimulated the development of alternative methods.
Incorporating Mechanistic Modeling & Simulation to Assist with Formulation Development and Regulatory Evaluations
A mechanistic, physiologically-based absorption/PK model was constructed in GastroPlus and validated across three dose levels (50, 100, and 300 mg) using in vivo data collected from tablets manufactured…
Challenges with Multi-Objective QSAR in Drug Discovery
The complexity in the drug discovery pipeline, in combination with the exponential growth of experimental and computational data, the technological achievements, and the access to large data sets, has led…
Photolytic and Photocatalytic Transformation of an Antipsychotic Drug Asenapine: Comparison of Kinetics, Identification of Transformation Products, and in silico Estimation of Their Properties
The photolytic and photocatalytic transformation of an antipsychotic drug asenapine with the use of H2O2 and TiO2 was studied. A method employing irradiation with a simulated full solar spectrum in the…
Parameter Sensitivity Analysis in GastroPlus®
This video describes how to set up a parameter sensitivity analysis (PSA) in GastroPlus.
Simulations Plus Reports Third Quarter FY2018 Financial Results
Record quarter as revenues grow 26.7%, 9MoFY18 net income up 63.8%
Board of Directors Announces Quarterly Dividend of $0.06 Per Share
Concentration Profiles of Carvedilol: A Comparison Between In Vitro Transfer Model and Dissolution Testing
The study aims to investigate the transfer behavior of the weakly basic BCS class II model drug carvedilol from the stomach to the small intestine and compare the concentration profiles of carvedilol that...
Design, Synthesis, and Evaluation of Novel L-phenylglycine Derivatives as Potential PPARγ Lead Compounds
In accordance with the structural characteristics of thiazolidinedione drugs and highly bioactive tyrosine derivatives, we tentatively designed the l-phenylglycine derivatives TM1and TM2 based on basic…
Utility of physiologically based pharmacokinetic (PBPK) modeling in oncology drug development and its accuracy: a systematic review
Physiologically based pharmacokinetic (PBPK) modeling, a mathematical modeling approach which uses a pharmacokinetic model to mimick human physiology to predict drug...
Inquiry of Literature Evidence for Induced Fit of Cytochrome P450 2C9 for Warfarin, Phenprocoumon, Flurbiprofen and Clopidogrel: A Critical Review
Cytochrome P450 oxygenases (CYP for short) are liver microsomal enzymes with a prosthetic hem(e) group that catalyze various types of hepatic biotransformation reactions including aromatic and...
Simulations Plus to Report Third Quarter 2018 Financial Results
Simulations Plus, Inc. (Nasdaq: SLP), announced today that it will report its third quarter financial results for fiscal year 2018, the period ended May 31, 2018, after the close of the financial markets on Tuesday, July 10, 2018.
Biopharmaceutical considerations in paediatrics with a view to the evaluation of orally administered drug products – a PEARRL review
In this review, the current biopharmaceutical approaches for evaluation of oral formulation performance in paediatrics are discussed.
Population Pharmacokinetics and Exposure-Response Analyses of Eslicarbazepine Acetate Efficacy and Safety in Monotherapy of Partial-Onset Seizures.
Eslicarbazepine acetate (ESL) is a once-daily oral antiepileptic drug (AED) indicated for partial-onset seizures (POS). ESL pharmacokinetics (PK) and exposure-response analyses were supported by...
The role of peroxisome proliferator-activated receptor gamma in prostate cancer
Despite great progress in the detection and treatment of prostate cancer, this disease remains an incredible health and economic burden. Although androgen receptor (AR)...
Ethanolic Extract of Pomegranate (Punica Granatum L) Peel: Acute Toxicity Tests on Zebrafish (Danio rerio) Embryos and its Toxicity Prediction by in silico
Antibiotic resistance causes many serious health problems that have emerged both in developed and developing countries. One of many examples of the antibiotic problem is resistance to Mycobacterium…
Relationship Between Fremanezumab Exposure and Efficacy in Preventive Therapy of Chronic Migraine in Adults
Fremanezumab is a fully humanized IgG2Δa/kappa monoclonal antibody that selectively targets calcitonin gene-related peptide (CGRP).
Relationship Between Fremanezumab Exposure and Efficacy in Preventive Therapy of Episodic Migraine in Adults
Fremanezumab is a fully humanized IgG2Δa/kappa monoclonal antibody that selectively targets calcitonin gene-related peptide (CGRP).
Lack of Relationship Between Fremanezumab Exposure and Cardiovascular Adverse Events in Phase 2 and Phase 3 Data Including Chronic and Episodic Migraine Patients
Fremanezumab is a fully humanized IgG2Δa/kappa monoclonal antibody that selectively targets calcitonin gene-related peptide (CGRP). Previously, fremanezumab was found to be effective and…