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:

The biowaivers extension for BCS Class III drugs: the effect of dissolution rate on on the bioequivalence of BCS Class III IR drugs predicted by computer simulation

The biowaivers extension for BCS Class III drugs: the effect of dissolution rate on on the bioequivalence of BCS Class III IR drugs predicted by computer simulation

Authors: Tsume Y, Amidon GL
Publication: Mol Pharm
Software: GastroPlus®

The Biopharmaceutical Classification System (BCS) guidance issued by the FDA allows waivers for in vivo bioavailability and bioequivalence studies for immediate-release...

In Silico Classification of Major Clearance Pathways of Drugs with Their Physiochemical Parameters

In Silico Classification of Major Clearance Pathways of Drugs with Their Physiochemical Parameters

Publication: Drug Metab Dispos
Software: ADMET Predictor®

Predicting major clearance pathways of drugs is important in understanding their pharmacokinetic properties in clinical use, such as drug-drug interactions and genetic...

Plasma pharmacokinetics of two consecutive doses of ferumoxytol in healthy subjects

Plasma pharmacokinetics of two consecutive doses of ferumoxytol in healthy subjects

Publication: Clin Pharmacol Ther

Intravenous (IV) iron is used to treat iron-deficiency anemia in patients with chronic kidney disease (CKD). Ferumoxytol is a novel iron formulation administered rapidly as two IV boluses of 510 mg each. In this placebo-controlled, double-blind...

Improving productivity with model-based drug development: an enterprise perspective

Improving productivity with model-based drug development: an enterprise perspective

Authors: Grasela TH, Slusser R
Publication: Clin Pharmacol Ther

The productivity of the pharma enterprise has fallen, as evidenced by a decline in regulatory submissions and less commercial success.