Process optimization and in vivo performance of docetaxel loaded PHBV-TPGS therapeutic vesicles: A synergistic approach.

Process optimization and in vivo performance of docetaxel loaded PHBV-TPGS therapeutic vesicles: A synergistic approach.

Publication: Int J Biol Macromol
Software: GastroPlus®

This research was motivated due to substantial requirement of improved treatment for breast cancer which accounts for over 0.52 million deaths annually worldwide.

Clinical Bioavailability of the Novel BACE1 Inhibitor Lanabecestat (AZD3293): Assessment of Tablet Formulations Versus an Oral Solution and the Impact of Gastric pH on Pharmacokinetics.

Clinical Bioavailability of the Novel BACE1 Inhibitor Lanabecestat (AZD3293): Assessment of Tablet Formulations Versus an Oral Solution and the Impact of Gastric pH on Pharmacokinetics.

Publication: Clin Pharmacol Drug Dev
Software: GastroPlus®
Division: PBPK

The relative bioavailability of lanabecestat administered as 2 tablet formulations versus an oral solution was investigated.

In vitro to in vivo extrapolation for high throughput prioritization and decision making

In vitro to in vivo extrapolation for high throughput prioritization and decision making

Publication: Toxicol In Vitro
Software: GastroPlus®
Division: PBPK

In vitro chemical safety testing methods offer the potential for efficient and economical tools to provide relevant assessments of human health risk.

Combining an In Vitro Kinetic Model with a Physiologically-Based Pharmacokinetic Model to Assess the Potential In Vivo Fate of Polyvinyl Pyrrolidone-Vinyl Acetate Copolymers

Combining an In Vitro Kinetic Model with a Physiologically-Based Pharmacokinetic Model to Assess the Potential In Vivo Fate of Polyvinyl Pyrrolidone-Vinyl Acetate Copolymers

Publication: Pharm Res
Software: GastroPlus®

To understand hydrolysis and alcoholysis of polyvinylpyrrolidone-co-vinylacetate (PVPVA) during formulation and storage, elucidate the reaction mechanism, establish an intrinsic kinetic model, and apply...

Monitoring of erlotinib in pancreatic cancer patients during long-time administration and comparison to a physiologically based pharmacokinetic model

Monitoring of erlotinib in pancreatic cancer patients during long-time administration and comparison to a physiologically based pharmacokinetic model

Publication: Cancer Chemother Pharmacol

In this study, a therapeutic drug monitoring (TDM) of erlotinib in pancreatic cancer patients was performed over 50 weeks to reveal possible alterations in erlotinib plasma concentrations.

Advances in experimental and mechanistic computational models to understand pulmonary exposure to inhaled drugs.

Advances in experimental and mechanistic computational models to understand pulmonary exposure to inhaled drugs.

Publication: Eur J Pharm Sci
Software: GastroPlus®

Prediction of local exposure following inhalation of a locally acting pulmonary drug is central to the successful development of novel inhaled medicines, as well as generic equivalents.

In silico modeling to optimize interpretation of liver safety biomarkers in clinical trials

In silico modeling to optimize interpretation of liver safety biomarkers in clinical trials

Authors: Church R, Watkins PB
Publication: Exp Biol Med (Maywood)
Software: DILIsym®

Current strategies to delineate the risk of serious drug-induced liver injury associated with drugs rely on assessment of serum biomarkers that have been utilized for many decades.

Cognitive Engineering – The Tools, Mindset, and Strategy for an Integrated Development Standard

Cognitive Engineering – The Tools, Mindset, and Strategy for an Integrated Development Standard

Authors: Grasela TH
Conference: ASCPT

Internet technology facilitates connectedness but often fails to foster collaboration. Advanced modeling techniques can provide insight for development discussions, but in many cases, these tools…

Pharmacokinetic Analysis of Gatilfoxacin in Plasma and Sinus Aspirate Drug Treatment of Maxiliary Sinusitis

Pharmacokinetic Analysis of Gatilfoxacin in Plasma and Sinus Aspirate Drug Treatment of Maxiliary Sinusitis

Conference: AAPS

A novel approach to collect sinus exudate was utilized and the time course of gatifloxacin (GAT) in the blood and at the primary infection site were assessed during treatment for acute maxillary sinusitis (AMS).

A framework for 2-stage global sensitivity analysis of GastroPlus™ compartmental models

A framework for 2-stage global sensitivity analysis of GastroPlus™ compartmental models

Publication: J Pharmacokinet Pharmacodyn
Software: GastroPlus®

Parameter sensitivity and uncertainty analysis for physiologically based pharmacokinetic (PBPK) models are becoming an important consideration for regulatory submissions, requiring further...

Food effects in paediatric medicines development for products Co-administered with food

Food effects in paediatric medicines development for products Co-administered with food

Publication: Int J Pharm
Software: GastroPlus®
Division: PBPK

A small amount of food is commonly used to aid administration of medicines to children to improve palatability and/or swallowability.

Pharmacokinetics And Exposure-Response Relationships Of Dasotraline In The Treatment Of Attention-Deficit/Hyperactivity Disorder In Adults

Pharmacokinetics And Exposure-Response Relationships Of Dasotraline In The Treatment Of Attention-Deficit/Hyperactivity Disorder In Adults

Conference: ACoP

To characterize the pharmacokinetic and pharmacodynamic data to explore the time course and exposure response relationships in Phase 2 to define dasotraline benefit to risk relationship in adult Attention...

Characterization of Population Pharmacokinetics of Cariprazine and Its Major Metabolites

Characterization of Population Pharmacokinetics of Cariprazine and Its Major Metabolites

Conference: American Psychiatric Association (APA)

Population pharmacokinetic (PK) analysis was undertaken to describe the concentration‑time profiles of cariprazine and its 2 major metabolites of similar pharmacological activity, desmethyl‑cariprazine...