Evaluation of Drug–Drug Interactions Between Clarithromycin and Direct Oral Anticoagulants Using Physiologically Based Pharmacokinetic Models

Evaluation of Drug–Drug Interactions Between Clarithromycin and Direct Oral Anticoagulants Using Physiologically Based Pharmacokinetic Models

Authors: Yang Z, Qu Y, Sun Y, Pan J, Zhou T, Yu Y
Publication: Pharmaceutics
Software: GastroPlus®
Division: PBPK

This study assessed the pharmacokinetic (PK) interactions between clarithromycin (a P-glycoprotein [P-gp] inhibitor) and four direct oral anticoagulants (DOACs) (P-gp substrates) using physiologically based PK (PBPK) models to elucidate the influence of P-gp in the interaction between them. 

Discovery of Penicillic Acid as a Chemical Probe Against Tau Aggregation in Alzheimer’s Disease

Discovery of Penicillic Acid as a Chemical Probe Against Tau Aggregation in Alzheimer’s Disease

Publication: Chemical Science
Software: ADMET Predictor®
Division: Cheminformatics

Alzheimer's Disease (AD) is a neurodegenerative disorder proven to be caused by the aggregation of protein tau into fibrils, resulting in neuronal death.

Weight Loss and Nausea from Subcutaneous and Oral Semaglutide Accurately Simulated with a QSP Model

Weight Loss and Nausea from Subcutaneous and Oral Semaglutide Accurately Simulated with a QSP Model

Conference: ACoP

The availability of effective GLP-1 receptor agonists (GLP-1RAs) for obesity treatment has greatly benefited patients. Balancing body weight (BW) loss with nausea is crucial to predict the effectiveness of these medications, along with understanding the impact of delivery methods. Quantitative Systems Pharmacology (QSP) modeling helps predict efficacy and adverse events, assessing key differences and similarities between treatment protocols.

Physiologically-Based Pharmacokinetic Modeling of Trofinetide in Moderate Renal Impairment for Phase 1 Clinical Study Dose Selection with Model Validation

Physiologically-Based Pharmacokinetic Modeling of Trofinetide in Moderate Renal Impairment for Phase 1 Clinical Study Dose Selection with Model Validation

Publication: Eur J Drug Metab Pharmacokinet
Software: GastroPlus®
Division: PBPK

Trofinetide, the first approved treatment for Rett syndrome (RTT), is primarily excreted unchanged in the urine; therefore, it is important to assess the extent to which the exposure is affected in patients with renal impairment.

Demonstrating Discriminatory Power of a Dissolution Method Using DDDPlus: Case Study of an ExtendedRelease Formulation and Use in Regulatory Justifications

Demonstrating Discriminatory Power of a Dissolution Method Using DDDPlus: Case Study of an ExtendedRelease Formulation and Use in Regulatory Justifications

Publication: Dissolution Tech
Software: DDDPlus™
Division: PBPK

Dissolution testing is an important attribute that provides insight into in vivo performance, batch-tobatch uniformity and consistent clinical quality.

Machine learning driven bioequivalence risk assessment at an early stage of generic drug development

Machine learning driven bioequivalence risk assessment at an early stage of generic drug development

Publication: Eur J Pharm Biopharm
Division: PBPK

Bioequivalence risk assessment as an extension of quality risk management lacks examples of quantitative approaches to risk assessment at an early stage of generic drug development.

Discovery and Characterization of BAY-184: A New Potent and Selective Acylsulfonamide-Benzofuran In Vivo-Active KAT6AB InhibitorCli

Discovery and Characterization of BAY-184: A New Potent and Selective Acylsulfonamide-Benzofuran In Vivo-Active KAT6AB InhibitorCli

Publication: J Med Chem
Software: ADMET Predictor®
Division: Cheminformatics

KAT6A and KAT6B genes are two closely related lysine acetyltransferases that transfer an acetyl group from acetyl coenzyme A (AcCoA) to lysine residues of target histone substrates, hence playing a key role in chromatin regulation.

Developing a Screening Strategy to Identify Hepatotoxicity and Drug Interaction Potential of Botanicals

Developing a Screening Strategy to Identify Hepatotoxicity and Drug Interaction Potential of Botanicals

Publication: J Diet Suppl
Software: GastroPlus®
Division: PBPK

Botanical supplements, herbal remedies, and plant-derived products are used globally. However, botanical dietary supplements are rarely subjected to robust safety testing unless there are adverse reports in post-market surveillance.