DSP-mAbX is a full human monoclonal antibody targeted to a cell surface antigen. The cross-reactivity of DSP-mAbX to the target antigen in human and monkey has already been confirmed. Here, a quantitative...
Systemization of Logistic Regression Analysis for Pharmacometric Applications
Efficacy and safety data are oftentimes collected as binary (yes/no) data in clinical trials during drug development. The implementation and growing use of CDISC standards in data collection and...
Mechanistic Modeling With Dilisym® Predicts Dose-Dependent Clinical Hepatotoxicity Of Amg 009 That Involves Bile Acid Transporter Inhibition
To predict the clinical hepatotoxicity of AMG 009 and species differences in AMG 009-mediated hepatotoxicity using DILIsym®, a mechanistic model of drug-induced liver injury
Conceptual Schemas
The central focus of MBR&D is not the mathematical equations but rather the conceptual synthesis process that integrates all available information and rational extrapolations to better understand drug pharmacology in the context of the disease process.
Visualize in KIWI 1.5 – Available Now!
Speed and agility is more important than ever as the demand for M&S increases. KIWI 1.5 allows you to easily select and compare parameters estimates and diagnostic plots across multiple candidate models in one view to make decisions quickly and confidently, and delivers high quality graphs to inform team decision making and put in regulatory documents- all formatted, all validated!
Development of Physiologically Based Pharmacokinetic / Pharmacodynamic Model for Indomethacin Disposition in Pregnancy
Findings of a recent clinical study showed indomethacin has lower plasma levels and higher steady-state apparent clearance in pregnant subjects when compared to those in non-pregnant subjects reported in separate studies.
Liver-selective distribution in rats supports the importance of active uptake into the liver via organic anion transporting polypeptides (OATPs) in humans
Organic anion transporting polypeptide (OATP) 1B1 and 1B3 are key molecules that are involved in hepatic uptake related to drug elimination, and OATP-mediated drug interactions are of clinical concern.
PEGylated y-tocotrienol isomer of vitamin E: Synthesis, characterization, in vitro cytotoxicity, and oral bioavailability
Vitamin E refers to a family of eight isomers divided into two subgroups, tocopherols and the therapeutically active tocotrienols (T3).
Acute toxicity prediction in multiple species by leveraging mechanistic ToxCast mitochondrial inhibition data and simulation of oral bioavailability
There is great interest in assessing the in vivo toxicity of chemicals using nonanimal alternatives.
The use of computational chemistry to predict toxicity of antioxidants food additives and its metabolites as a reference for food safety regulation
Antioxidant food additives are used to prevent or slowing down the oxidation process in foods.
Lipidic dispersion to reduce food dependent oral bioavailability of fenofibrate: in vitro, in vivo and in silico assessments
Novel formulations that overcome the solubility limitations of poorly water soluble drugs (PWSD) are becoming ever more critical to a drug development process inundated with these compounds.
Analyzing the structural sensitivity of QSAR models using matched molecular
This video explores analyzing the structural sensitivity of QSAR models using matched molecular pairs using MedChem Studio™
Modeling and Simulation to Support Clinical Development of Eslicarbazepine Acetate in Partial-Onset Epilepsy
Eslicarbazepine acetate (ESL) is a once-daily (QD) oral antiepileptic drug (AED) approved by the US Food and Drug Administration for the treatment of partial-onset seizures (POS) as monotherapy or…
Preclinical pharmacokinetic studies of 3-deazaneplanocin A, a potent epigenetic anticancer agent, and its human pharmacokinetic prediction using GastroPlus™
DZNep is a potential epigenetic drug, and exerts potent anti-proliferative and pro-apoptotic effects on broad-spectrum carcinomas via disruption of the EZH2 pathway.
Application of physiologically based pharmacokinetic modeling in the prediction of pharmacokinetics of bicyclol controlled-release formulation in human
Physiologically based pharmacokinetic (PBPK) modeling can assist in formulation development.
1,4-Oxazine beta-secretase (BACE1) inhibitors: from hit generation to orally bioavailable brain penetrant leads
Alzheimer’s disease (AD) is a progressive neurodegenerative disorder and the major cause of dementia in the elderly.
FDA’s Office of New Drug Products Places Order for 50 Additional Licenses to GastroPlus™
Additional Licenses Required to Meet Increasing Number of Submissions Utilizing GastroPlus
Regulatory Considerations for Approval of Generic Inhalation Drug Products in the US, EU, Brazil, China, and India
This article describes regulatory approaches for approval of "generic" orally inhaled drug products (OIDPs) in the United States, European Union, Brazil, China and India.
Simulations Plus Reports Preliminary Revenues for Fourth Quarter and Fiscal Year 2015
Company Reports Record Fourth-Quarter and Full-Year Revenues