Physiologically Based Pharmacokinetic/Pharmacodynamic Modeling to Evaluate the Absorption of Midazolam Rectal Gel

Physiologically Based Pharmacokinetic/Pharmacodynamic Modeling to Evaluate the Absorption of Midazolam Rectal Gel

Publication: Eur J Pharm Sci
Software: GastroPlus®

We aimed to 1) develop physiologically based pharmacokinetic/pharmacodynamic (PBPK/PD) models of a novel midazolam rectal gel in healthy adults, 2) assess the contribution of different physiologically relevant...

Current Regulatory Requirements for Biosimilars in Six Member Countries of BRICS-TM: Challenges and Opportunities

Current Regulatory Requirements for Biosimilars in Six Member Countries of BRICS-TM: Challenges and Opportunities

Publication: Front Med (Lausanne)
Division: PBPK

The aim of the study was to identify, interpret, and compare the current perspectives of regulatory agencies in six member countries of BRICS-TM (Brazil, Russia, India, China, South Africa, Turkey, and Mexico) on the different criteria used for biosimilar development and marketing authorisation process. 

Physiologically Based Pharmacokinetic Modelling of Inhaled Nemiralisib: Mechanistic Components for Pulmonary Absorption, Systemic Distribution, and Oral Absorption

Physiologically Based Pharmacokinetic Modelling of Inhaled Nemiralisib: Mechanistic Components for Pulmonary Absorption, Systemic Distribution, and Oral Absorption

Publication: Clin Pharmacokinet
Software: GastroPlus®

Physiologically based pharmacokinetic (PBPK) modelling has evolved to accommodate different routes of drug administration and enables prediction of drug concentrations in tissues as well as plasma.

Development of PBPK model for intra-articular injection in human: methotrexate solution and rheumatoid arthritis case study

Development of PBPK model for intra-articular injection in human: methotrexate solution and rheumatoid arthritis case study

Publication: J Pharmacokinet Pharmacodyn
Software: GastroPlus®
Division: PBPK

A physiologically based model describing the dissolution, diffusion, and transfer of drug from the intra-articular (IA) space to the plasma, was developed for GastroPlus v9.8.

The emerging role of physiologically-based pharmacokinetic/biopharmaceutics modeling in formulation development

The emerging role of physiologically-based pharmacokinetic/biopharmaceutics modeling in formulation development

Publication: Arch Pharm
Software: GastroPlus®

Computer-based (in silico) modeling & simulation tools have been embraced in different fields of pharmaceutics for a variety of applications.

Pharmacokinetics of tulathromycin in pregnant ewes (Ovis aries) challenged with Campylobacter jejuni

Pharmacokinetics of tulathromycin in pregnant ewes (Ovis aries) challenged with Campylobacter jejuni

Publication: PLoS One
Software: PKanalix®

The purpose of this study was to evaluate the pharmacokinetics of tulathromycin in the plasma and maternal and fetal tissues of pregnant ewes when administered within 24 hours of a...

PBPK Modeling as a Tool for Predicting and Understanding Intestinal Metabolism of Uridine 5′-Diphospho-Glucuronosyltransferase Substrates

PBPK Modeling as a Tool for Predicting and Understanding Intestinal Metabolism of Uridine 5′-Diphospho-Glucuronosyltransferase Substrates

Publication: Pharmaceutics
Division: PBPK

Uridine 5′-diphospho-glucuronosyltransferases (UGTs) are expressed in the small intestines, but prediction of first-pass extraction from the related metabolism is not well studied.

Quantitative Systems Toxicology Modeling Predicts that Reduced Biliary Efflux Contributes to Tolvaptan Hepatotoxicity

Quantitative Systems Toxicology Modeling Predicts that Reduced Biliary Efflux Contributes to Tolvaptan Hepatotoxicity

Publication: Clinical Pharmacology & Therapeutics
Software: DILIsym®

Patients with autosomal dominant polycystic kidney disease (ADPKD) exhibit enhanced susceptibility to tolvaptan hepatotoxicity relative to other patient populations.

Computational pharmaceutics – A new paradigm of drug delivery

Computational pharmaceutics – A new paradigm of drug delivery

Authors: Wang W, Ye Z, Gao H, Ouyang D
Publication: J Control Release
Software: GastroPlus®

In recent decades pharmaceutics and drug delivery have become increasingly critical in the pharmaceutical industry due to longer time, higher cost, and less productivity of new molecular entities (NMEs).

In Vitro-In Silico Tools for Streamlined Development of Acalabrutinib Amorphous Solid Dispersion Tablets

In Vitro-In Silico Tools for Streamlined Development of Acalabrutinib Amorphous Solid Dispersion Tablets

Publication: Pharmaceutics
Software: GastroPlus®

Amorphous solid dispersion (ASD) dosage forms can improve the oral bioavailability of poorly water-soluble drugs, enabling the commercialization of new chemical entities and improving the efficacy and patient...