Combining “Bottom-up” and “Top-down” Approaches to Assess the Impact of Food and Gastric pH on Pictilisib (GDC-0941) Pharmacokinetics

Combining “Bottom-up” and “Top-down” Approaches to Assess the Impact of Food and Gastric pH on Pictilisib (GDC-0941) Pharmacokinetics

Publication: CPT Pharmacometrics Syst Pharmacol
Software: GastroPlus®
Division: PBPK

Pictilisib, a weakly basic compound, is an orally administered, potent, and selective pan-inhibitor of phosphatidylinositol 3-kinases for oncology indications.

Predictive Biopharmaceutics and Pharmacokinetics: Modeling and Simulation

Predictive Biopharmaceutics and Pharmacokinetics: Modeling and Simulation

Publication: Developing solid oral dosage forms : pharmaceutical theory & practice
Software: GastroPlus®

Scientists have made great discoveries concerning human physiology and gained tremendous knowledge during drug development efforts.

Investigating the state of physiologically based kinetic modelling practices and challenges associated with gaining regulatory acceptance of model applications.

Investigating the state of physiologically based kinetic modelling practices and challenges associated with gaining regulatory acceptance of model applications.

Publication: Regul Toxicol Pharmacol
Software: GastroPlus®

Physiologically based kinetic (PBK) models are used widely throughout a number of working sectors, including academia and industry, to provide insight into the dosimetry related to observed adverse...

Effect of the pulmonary deposition and in vitro permeability on the prediction of plasma levels of inhaled budesonide formulation

Effect of the pulmonary deposition and in vitro permeability on the prediction of plasma levels of inhaled budesonide formulation

Publication: Int J Pharm
Software: GastroPlus®

The growing interest in the inhalable pharmaceutical products requires advanced approaches to safe and fast product development, such as in silico tools that can be used...

Abstract B083: Population pharmacokinetics and pharmacodynamics for an oral Notch inhibitor, LY3039478, in patients with advanced cancer and healthy volunteers

Abstract B083: Population pharmacokinetics and pharmacodynamics for an oral Notch inhibitor, LY3039478, in patients with advanced cancer and healthy volunteers

Division: PBPK

Background: LY3039478 is an oral Notch inhibitor that prevents release of the Notch Intracellular Domain (NICD) by inhibiting proteolytic activity of the gamma (γ)-secretase complex.

Industry’s View on Using Quality Control, Biorelevant, and Clinically Relevant Dissolution Tests for Pharmaceutical Development, Registration, and Commercialization.

Industry’s View on Using Quality Control, Biorelevant, and Clinically Relevant Dissolution Tests for Pharmaceutical Development, Registration, and Commercialization.

Publication: J Pharm Sci
Software: GastroPlus®

This article intends to summarize the current views of the IQ Consortium Dissolution Working Group, which comprises various industry companies, on the roles of dissolution testing throughout...

The solubility-permeability trade-off of progesterone with cyclodextrins under physiological conditions: Experimental observations and computer simulations

The solubility-permeability trade-off of progesterone with cyclodextrins under physiological conditions: Experimental observations and computer simulations

Authors: Sun L, Zhang B, Sun J
Publication: J Pharm Sci
Software: GastroPlus®

This study intended to evaluate the effect of cyclodextrins on the apparent solubility and permeability of lipophilic drugs under physiological conditions and establish in silico model to choose...

Pharmacokinetics of Tedizolid in Obese and Nonobese Subjects

Pharmacokinetics of Tedizolid in Obese and Nonobese Subjects

Publication: J Clin Pharmacol

Obesity, defined as body mass index (BMI) 30 kg/m2, is a growing problem worldwide; the prevalence is 38% in the US adult population.

Challenges in translational drug research in neuropathic and inflammatory pain: the prerequisites for a new paradigm

Challenges in translational drug research in neuropathic and inflammatory pain: the prerequisites for a new paradigm

Publication: Eur J Clin Pharmacol
Division: PBPK

Despite an improved understanding of the molecular mechanisms of nociception, existing analgesic drugs remain limited in terms of efficacy in chronic conditions, such as neuropathic pain.

Looking to the future of drug-induced liver injury: an interview with Paul B Watkins

Looking to the future of drug-induced liver injury: an interview with Paul B Watkins

Authors: Watkins PB
Publication: Future Sci OA
Software: DILIsym®

Paul Watkins talks to Francesca Lake, Head of Open Access Publishing: Paul is The Howard Q Ferguson Professor in the Eshelman School of Pharmacy at The University of North Carolina at Chapel Hill (UNC, NC, USA), and an expert in drug safety and drug-induced liver injury (DILI).

Population Pharmacokinetic Evaluation and Missed-Dose Simulations for Eslicarbazepine Acetate Monotherapy in Patients With Partial-Onset Seizures

Population Pharmacokinetic Evaluation and Missed-Dose Simulations for Eslicarbazepine Acetate Monotherapy in Patients With Partial-Onset Seizures

Publication: Clin Pharmacol Drug Dev

Given the potential consequences of antiepileptic therapy nonadherence, missed-dose scenarios of 12- to 48-hour dose delays (4-hour intervals) for eslicarbazepine acetate monotherapy...

In vitro and in vivo evaluation of gastro-retentive carvedilol loaded chitosan beads using GastroPlus™

In vitro and in vivo evaluation of gastro-retentive carvedilol loaded chitosan beads using GastroPlus™

Publication: Int J Biol Macromol
Software: GastroPlus®

The objective of present investigation was to develop gastro-retentive controlled release system of carvedilol using biological macromolecule, chitosan. 32 full factorial design was adopted for...