Development of A Mechanistic in vitro – in vivo Correlation for Theophylline

Development of A Mechanistic in vitro – in vivo Correlation for Theophylline

Conference: AAPS
Software: GastroPlus®
Division: PBPK

Theophylline is used to prevent and treat wheezing, shortness of breath, and difficulty breathing caused by asthma, chronic bronchitis, emphesema, and other lung diseases. Immediate release oral…

Application of a Respiratory PBPK Model for Predicting Deposition and Disposition following Inhaled Administration of Morphine

Application of a Respiratory PBPK Model for Predicting Deposition and Disposition following Inhaled Administration of Morphine

Conference: AAPS
Software: GastroPlus®
Division: PBPK

Demonstrate the pulmonary component of the GastroPlus™ Additional Dosage Routes Module™ (ADRM) simulation to develop a pharmacokinetic (PK) and pharmacodynamic (PD) model for inhaled…

Mechanistic PBPK Simulation in Place of In Vivo Drug-Drug Interaction (DDI) Studies for Compliance with Regulatory Requirements of EMA and FDA

Mechanistic PBPK Simulation in Place of In Vivo Drug-Drug Interaction (DDI) Studies for Compliance with Regulatory Requirements of EMA and FDA

Conference: AAPS
Software: GastroPlus®
Division: PBPK

To highlight the application and validation of PBPK DDI simulation results obtained using GastroPlus™ in compliance with newly proposed European Medicines Agency (EMA) and US FDA guidelines for the…

You WILL Innovate!

You WILL Innovate!

Few among us would think highly of a leader who directed us to innovate on demand. After all, innovation is something that comes from a mysterious creative force that strikes like lightning to the fortunate inventor, bringing with it fame and fortune. Think Bill Hewlett and Dave Packard; Steve Jobs and Steve Wozniak; Bill Gates; Mark Zuckerberg; or Tim Berners-Lee (huh?) [1].

Bendamustine pharmacokinetic profile and exposure-response relationships in patients with indolent non-Hodgkin’s lymphoma

Bendamustine pharmacokinetic profile and exposure-response relationships in patients with indolent non-Hodgkin’s lymphoma

Publication: Cancer Chemother Pharmacol

The pharmacokinetic profiles of bendamustine and active metabolites were defined in patients with rituximab-refractory, relapsed indolent B-cell non-Hodgkin's lymphoma, and supported understanding of exposure-response relationships for efficacy and safety.

Dissolution modeling of bead formulations and predictions of bioequivalence for a highly soluble, highly permeable drug

Dissolution modeling of bead formulations and predictions of bioequivalence for a highly soluble, highly permeable drug

Publication: Mol Pharm
Software: GastroPlus®

The objective of this study was to assess the impact of observed in vitro dissolution rate differences on in vivo pharmacokinetics for two enteric-coated bead formulations...

Model hurricanes.

Model hurricanes.

Although some meteorological modelers may disagree, it seems to me that models predicting development and movement of hurricanes are getting more and more accurate.

But…my projects are special.

But…my projects are special.

Scientists in the field of pharmaceutical research and development face a most daunting challenge. Our understanding of the diseases we work to treat grows more complex and perplexing with each new published study. Take, for example, the gusher of information coming out on Alzheimer’s disease. How can research findings from genetics, neurology, nutrition, protein chemistry, pharmacology, and epidemiology (just to name a few) be tracked, sorted, and used?

Beyond Filters: ADMET Risk™ for Multi-objective Drug Development

Beyond Filters: ADMET Risk™ for Multi-objective Drug Development

Conference: ACS
Software: ADMET Predictor®
Division: PBPK

We calculated predictions for over 30 properties relevant to absorption, distribution, metabolism, excretion and toxicity (ADMET) for a large and pharmaceutically pertinent...

Not too complicated for words.

Not too complicated for words.

Jackson Pollock’s Autumn Rhythm (seen here) is an example of a complex painting that can be grasped with a few moments of contemplation, according to Terry Teachout (links to a dead page) in the Wall Street Journal. Pollock worked during the mid 20th century, when nature was assumed to be random. However, as Robert Taylor (links to content that is no longer available) explained in a 2002 Scientific American article: