Development, validation and application of physiologically based biopharmaceutics model to justify the change in dissolution specifications for DRL ABC extended release tablets

Development, validation and application of physiologically based biopharmaceutics model to justify the change in dissolution specifications for DRL ABC extended release tablets

Publication: Drug Dev Ind Pharm
Software: GastroPlus®

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.

Simulation of Remdesivir Pharmacokinetics and Its Drug Interactions

Simulation of Remdesivir Pharmacokinetics and Its Drug Interactions

Authors: Deb S, Reeves AA
Software: GastroPlus®

Remdesivir, a drug originally developed against Ebola virus, is currently recommended for patients hospitalized with coronavirus disease of 2019 (COVID-19).

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

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

Publication: Invest. Ophthal. and Vis. Sci.
Therapeutic Areas: Ophthalmology

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?

Particle Deposition in Respiratory Tract: Where are the Limits?

Publication: CMBEBIH 2021
Software: GastroPlus®

In last two decades in silico biopharmaceutics modelling has become increasingly important in all stages of drug development.

Development and In Vitro Evaluation of Controlled Release Viagra® Containing Poloxamer-188 Using Gastroplus™ PBPK Modeling Software for In Vivo Predictions and Pharmacokinetic Assessments

Development and In Vitro Evaluation of Controlled Release Viagra® Containing Poloxamer-188 Using Gastroplus™ PBPK Modeling Software for In Vivo Predictions and Pharmacokinetic Assessments

Publication: Pharmaceuticals
Software: GastroPlus®

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.

Pharmacokinetic/pharmacodynamic modeling of drug interactions at the P2Y12 receptor between selatogrel and oral P2Y12 antagonists

Pharmacokinetic/pharmacodynamic modeling of drug interactions at the P2Y12 receptor between selatogrel and oral P2Y12 antagonists

Publication: CPT Pharmacometrics Syst Pharmacol

Selatogrel is a potent and reversible P2Y12 receptor antagonist developed for subcutaneous self‐administration by patients with suspected acute myocardial infarction.

Evaluating the impact of physiological properties of the gastrointestinal tract on drug in vivo performance using Physiologically Based Biopharmaceutics Modeling and virtual clinical trials

Evaluating the impact of physiological properties of the gastrointestinal tract on drug in vivo performance using Physiologically Based Biopharmaceutics Modeling and virtual clinical trials

Publication: J Pharm Sci
Software: GastroPlus®

The physiological properties of the gastrointestinal tract, such as pH, fluid volume, bile salt concentration, and gastrointestinal transit time, are highly variable in vivo.

High-Fat Breakfast Increases Bioavailability of Albendazole Compared to Low-Fat Breakfast: Single-Dose Study in Healthy Subjects

High-Fat Breakfast Increases Bioavailability of Albendazole Compared to Low-Fat Breakfast: Single-Dose Study in Healthy Subjects

Publication: Front Pharmacol

Albendazole is a benzimidazole carbamate drug with anthelmintic and antiprotozoal activity against intestinal and tissue parasites. It has been described that the administration with meals increases albendazole absorption.

A novel in silico method to predict drug PK profile in human and its application to build the PBPK model of Hydroxychloroquine for COVID-19 treatment

A novel in silico method to predict drug PK profile in human and its application to build the PBPK model of Hydroxychloroquine for COVID-19 treatment

Authors: Zhai J
Publication: Univ Pittsburgh

The first part of this study is to develop a novel protocol to predict the pharmacokinetic profiles of a target drug based on the Physiologically based pharmacokinetic (PBPK) model of a structurally similar template drug by combining predictions from two software for PBPK modeling, the SimCYP simulator and ADMET Predictor.

Development of an In Vivo Predictive Dissolution Methodology of Topiroxostat Immediate-Release Tablet Using In Silico Simulation

Development of an In Vivo Predictive Dissolution Methodology of Topiroxostat Immediate-Release Tablet Using In Silico Simulation

Publication: AAPS PharmSciTech
Software: GastroPlus®

The main objective of this study was to develop an in vivo predictive dissolution (IVPD) model for topiroxostat immediate-release (IR) formulation...

Concentration-QTc Analysis of Quizartinib in Patients with Relapsed/Refractory Acute Myeloid Leukemia

Concentration-QTc Analysis of Quizartinib in Patients with Relapsed/Refractory Acute Myeloid Leukemia

Publication: Cancer Chemother Pharmacol

This analysis evaluated the relationship between concentrations of quizartinib and its active metabolite AC886 and QT interval corrected using Fridericia's formula (QTcF) in patients with...