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Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls: A Workshop Summary Report
The implementation of clinically relevant drug product specifications (CRDPS) depends on establishing a link between in vitro performance and in vivo exposure.
Omics for Bioprospecting and Drug Discovery from Bacteria and Microalgae
“Omics” represent a combinatorial approach to high-throughput analysis of biological entities for various purposes.
Computational Prediction and Experimental Validation of ADMET Properties for Potential Therapeutics
The drug development process in the United States is an expensive and lengthy process, usually taking a decade or more to gain approval for a...
American Association of Pharmaceutical Scientists (AAPS) and Chinese National Institutes for Food and Drug Control (NIFDC) Joint Workshop on Dissolution, Bioequivalence, Product Performance, and Quality
The second joint workshop sponsored by the American Association of Pharmaceutical Scientists...
Absorption, distribution, metabolism, excretion, and toxicity evaluation of Papua red fruit flavonoids through a computational study
Red Fruit (RF) (Pandanus conoideus Lam.) was used as traditional medicine for Papuans and consumed as a daily meal.
Oligoadenylate Synthetase 1 enhances DNA sensor cGAS translation to mediate WNV antiviral activity
Interferons inhibit virus replication through the expression of interferon stimulated genes (ISGs).
Amorphous Solid Dispersions in Early Stage of Formulation Development: Predicting Excipient Influence on Dissolution Profiles Using DDDPlus
Excipients play an important role in the formulation of dosage forms and can be used to improve the bioavailability
of a drug through physical interactions that alter the rate of dissolution of a drug.
Case study: Implementing a proportional hazard model and calculating hazard ratios
Proportional hazard models are a popular class of models for time-to-event data.
Improving the Accuracy of Predicted Human Pharmacokinetics: Lessons Learned from the AstraZeneca Drug Pipeline Over Two Decades
During drug discovery and prior to the first human dose of a novel candidate drug, the pharmacokinetic (PK) behavior of the drug in...
Prediction methods of drug-drug interactions of non-oral CYP3A4 substrates based on clinical interaction data after oral administrations – Validation with midazolam, alfentanil, and verapamil after intravenous administration and prediction for blonanserin transdermal patch
Drug-drug interactions (DDI) have been examined for various drugs for oral use, but less for non-oral applications.
Population Pharmacokinetic and Pharmacokinetic / Pharmacodynamic Modeling of Weight‐Based Intravenous Reslizumab Dosing
Reslizumab 3.0 mg/kg has demonstrated efficacy in clinical studies of patients with eosinophilic asthma and a history of exacerbations.
Exposure–Response Analyses to Support Optimal Dosing Regimens of Ceftolozane/Tazobactam in Patients With Hospital-Acquired Pneumonia (HAP)/Ventilator-Associated Pneumonia (VAP) in ASPECT-NP
Nosocomial pneumonia comprises hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP) and is the most common nosocomial infection; mortality rates range from 3%–22% for nonventilated HAP (10%–40% for ventilated HAP) and from 6%–29% for VAP.
A Novel Combination of Vitamin C, Curcumin and Glycyrrhizic Acid Potentially Regulates Immune and Inflammatory Response Associated with Coronavirus Infections: A Perspective from System Biology Analysis
Novel coronaviruses (CoV) have emerged periodically around the world in recent years.
Case study: Inter-occasion variability and effect of guar gum on alcohol concentration in blood
In this case study, the MonolixSuite is used to analyze and model the PK of alcohol, measured in two different occasions where subjects...
Improved Oral Pharmacokinetics of Pentoxifylline with Palm Oil and Capmul® MCM Containing Self-Nano-Emulsifying Drug Delivery System
Pentoxifylline (PTX), an anti-hemorrhage drug used in the treatment of intermittent claudication, is extensively metabolized by the liver resulting in a reduction of the therapeutic levels within a short duration of time.
Discordance between Etravirine Phenotype and Genotype-Based Predicted Phenotype for Subtype C HIV-1 from First-Line Antiretroviral Therapy Failures in South Africa
Etravirine (ETR) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) used in treatment-experienced individuals.
Insights into the degradation chemistry of tazarotene, a third generation acetylenic retinoid: LC-HRMS (Orbitrap), LC-MSn and NMR characterization of its degradation products, and prediction of their physicochemical and ADMET properties
Tazarotene is a prodrug that belongs to the acetylenic class of retinoids.
In vivo metabolic investigation of cetilistat in normal versus pseudo‐germ‐free rats using UPLC‐QTOFMS/MS and in silico toxicological evaluation of its metabolites
Cetilistat (CET) is a pancreatic lipase inhibitor approved for management of obesity after the serious adverse effects exhibited by its analogue orlistat.
Feature of the week #86: Estimating the conditional distributions
The task Conditional distribution in Monolix estimates the individual conditional distributions, which represent the individual...