A Systems Approach to Resource Allocation in an Integrated Research and Development Environment

A Systems Approach to Resource Allocation in an Integrated Research and Development Environment

Conference: Pharmaceutical Special Interest Group (PharmaSIG)

Typically, at the beginning of a project, the scope is defined along with the timelines and budget. As project team leaders negotiate with functional managers to recruit key team members, including…

Lean Production

Lean Production

I have been reading The Machine That Changed the World: The Story of Lean Production (1), by James Womack and others from MIT’s International Motor Vehicle Program (Content no longer available) research team. This book caused a sensation 20 years ago with its description of the Toyota Production System. The blurb on the book’s back cover says, “The hallmarks of lean production are teamwork, communication, and efficient use of resources. The results are remarkable cars with one-third the defects, built in half the factory space, using half the man-hours.”

Semi-mechanistic PK/PD Model of the Effect of Odanacatib, a Cathepsin K Inhibitor, on Bone Turnover to Characterize Lumbar Spine Bone Mineral Density in Two Phase II Studies of Postmenopausal Women

Semi-mechanistic PK/PD Model of the Effect of Odanacatib, a Cathepsin K Inhibitor, on Bone Turnover to Characterize Lumbar Spine Bone Mineral Density in Two Phase II Studies of Postmenopausal Women

Odanacatib (MK-0822), a potent, orally-active inhibitor of cathepsin K, is under clinical development for treatment of postmenopausal osteoporosis. This poster describes base model development of a...

Paul Volcker: Think More Boldly

Paul Volcker: Think More Boldly

In December 2009, The Wall Street Journal sponsored its second Future of Finance Initiative (links to a dead page) to provide a forum for 80 of the world’s top financiers to brainstorm suggestions for reforming the financial system in the wake of the 2008 implosion of the global economy.

Modeling Drug Disposition of Timolol in Ocular Tissues of Rabbit following Topical Eye Drops

Modeling Drug Disposition of Timolol in Ocular Tissues of Rabbit following Topical Eye Drops

Conference: ISOPT
Software: GastroPlus®
Division: PBPK

Recently, we reported the successful application of a novel mathematical model describing drug disposition in eye compartments to simulate disposition of clonidine  after topical (eye drop) administration.

Prediction of pharmacokinetic profile of valsartan in human based on in vitro uptake transport data

Prediction of pharmacokinetic profile of valsartan in human based on in vitro uptake transport data

Publication: J Pharmacokinet Pharmacodyn
Software: GastroPlus®

The aim of this study was to evaluate a strategy based on a physiologically based pharmacokinetic (PBPK) model for the prediction of PK profiles in human using in vitro...