Introduction: Graft survival in pediatric kidney transplant patients has increased significantly within the last three decades, correlating with the discovery and utilization of new immunosuppressants as well as...
Experimental Solubility of Ketoconazole, Validation Models, and In vivo Prediction in Human Based on GastroPlus
The study aimed to identify a suitable cosolvent + water mixture for subcutaneous...
Beta-thalassemia major alters sofosbuvir/ledipasvir exposure in Hepatitis C virus infected adolescent patients
Hepatitis C virus (HCV) infected adolescents with beta-thalassemia major (BTM) are considered a potential population for HCV micro-elimination model development where BTM may...
A physiologically-based nanocarrier biopharmaceutics model to reverse-engineer the in vivo drug release
Over the years, a wide variety of nanomedicines has entered global markets, providing a blueprint for the emerging generics industry.
PBPK Modeling Approach to Predict the Behavior of Drugs Cleared by Kidney in Pregnant Subjects and Fetus
The purpose of this study was to develop a physiologically based pharmacokinetic (PBPK) model predicting the pharmacokinetics (PK) of different compounds in pregnant subjects.
Application of a dual mechanistic approach to support bilastine dose selection for older adults
The objective of this study was to evaluate bilastine dosing recommendations in older adults and overcome the limitation of insufficient data from phase I studies in this underrepresented population.
Use of Physiologically Based Pharmacokinetic Modeling for Predicting Drug–Food Interactions: Recommendations for Improving Predictive Performance of Low Confidence Food Effect Models
Food can alter drug absorption and impact safety and efficacy.
Development, validation and application of physiologically based biopharmaceutics model to justify the change in dissolution specifications for DRL ABC extended release tablets
The generic drug product DRL ABC is an Extended Release (ER) Tablet manufactured by Dr. Reddy’s Laboratories Limited and have multi point dissolution as part of release specification.
Meta-Assessment of Metformin Absorption and Disposition Pharmacokinetics in Nine Species
The objective of this study was to systematically assess literature datasets and quantitatively analyze metformin PK in plasma and some tissues of nine species.
Simulation of Remdesivir Pharmacokinetics and Its Drug Interactions
Remdesivir, a drug originally developed against Ebola virus, is currently recommended for patients hospitalized with coronavirus disease of 2019 (COVID-19).
Application of physiologically based biopharmaceutics modeling (PBBM) to understand the impact of dissolution differences on in vivo performance of immediate release products: The case of bisoprolol
Merck KGaA observed slight differences in the dissolution of Concor® (bisoprolol) batches over the years.
Oral APX3330 treatment reduces L-CNV lesions in preclinical mouse model and confirms Phase 2 DR/DME clinical dose with sufficient distribution to human retina using PBPK modeling
APX3330 is a small molecule inhibitor of Ref-1, a target involved in key vascular and inflammatory ocular disease processes including diabetic retinopathy (DR), diabetic macular edema (DME) and wetAMD.
Particle Deposition in Respiratory Tract: Where are the Limits?
In last two decades in silico biopharmaceutics modelling has become increasingly important in all stages of drug development.
COVID-19 vaccines and treatments: When speed is necessary and not enough
The infectivity and severity of the severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) pandemic (coronavirus disease 2019 [COVID-19]) has fostered the need for speed in the work to make progress against the virus.
Development and In Vitro Evaluation of Controlled Release Viagra® Containing Poloxamer-188 Using Gastroplus™ PBPK Modeling Software for In Vivo Predictions and Pharmacokinetic Assessments
Sildenafil is the active substance in Viagra® tablets, which is approved by the FDA to treat sexual dysfunction in men. Poor solubility and short half-life, however, can limit the span of its effectiveness.
Scaling Approaches for Pediatric Dose Selection: the Fremanezumab (AJOVY®) Journey to Select a Phase 3 Dose Using Pharmacokinetic Data From a Phase 1 Study. Pharmaceuticals
Fremanezumab, a fully humanized IgG2Δa/kappa monoclonal antibody, selectively targets the calcitonin-gene-related peptide (CGRP) and
Administration in fed state but not controlled release in the colon increases oral bioavailability of DF030263, a promising drug candidate for chronic lymphocytic leukemia
For treatment of chronic cancers, the oral administration route is preferred as it provides numerous advantages over other delivery routes.
Pharmacokinetic/pharmacodynamic modeling of drug interactions at the P2Y12 receptor between selatogrel and oral P2Y12 antagonists
Selatogrel is a potent and reversible P2Y12 receptor antagonist developed for subcutaneous self‐administration by patients with suspected acute myocardial infarction.
Scaffold-Hopping Strategy on a Series of Proteasome Inhibitors Led to a Preclinical Candidate for the Treatment of Visceral Leishmaniasis
There is an urgent need for new treatments for visceral leishmaniasis (VL), a parasitic infection which impacts heavily large areas of East Africa, Asia, and South America
Evaluating the impact of physiological properties of the gastrointestinal tract on drug in vivo performance using Physiologically Based Biopharmaceutics Modeling and virtual clinical trials
The physiological properties of the gastrointestinal tract, such as pH, fluid volume, bile salt concentration, and gastrointestinal transit time, are highly variable in vivo.