Update: For another perspective on tech employment in the United States and China, see Andy Grove’s recent article in Bloomberg Businessweek.
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 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
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
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
The productivity of the pharma enterprise has fallen, as evidenced by a decline in regulatory submissions and less commercial success.
A pH-Dilution Method for Estimation of Biorelevant Drug Solubility along the Gastrointestinal Tract: Application to Physiologically Based Pharmacokinetic Modeling
Physiologically based pharmacokinetic (PBPK) modeling tools have become an integral part of the modern drug discovery−development process.
Robots
Take a look at BigDog and his amazing robot pals in this link to the New York Times. Or, if you love cute and cuddly, you should check out Paro.
Simulations Plus Reports Third Quarter FY2010 Financial Results
Another Record Quarter with Revenues up 15% and Earnings up 30% over Last Year’s Q3
World (Cup) Cultures
One of the true pleasures of my job is the opportunity to travel and meet people from all over the world. Different cultures presume different business and social behaviors, of course.* But I have found that in spite of the differences, there are at least two similarities among world cultures: a passion to cheer for your national team to win the World Cup and a nearly universal reviling of the vuvuzelas.
Life’s Too short
In a recent Wall Street Journal column, Terry Teachout had a wonderful essay questioning the complexity of modern art.* He quotes from James Joyce’s Finnegans Wake, which contains sentences like this:
Simulations Plus Reports Preliminary Revenues for Third Fiscal Quarter of FY2010
New Record Quarter of $3.1 Million Due to Sustained Growth in Revenues
Sense and Sensibilities of Science
If you want to understand process formalization, read Jane Austen.
Forensic Pharmacometrics: Part 2 – Deliverables for Regulatory Submission
As modeling and simulation results become increasingly integral to critical development-related decision-making and program outcomes, the consequences of poor documentation of pharmacometric analyses can…
Rationalizing the development of live attenuated virus vaccines
The design of vaccines against viral disease has evolved considerably over the past 50 years. Live attenuated viruses (LAVs)-those created by passaging a virus in cultured...
Physiologically-Based Pharmacokinetic (PBPK) Modeling of Diltiazem-Midazolam Drug-Drug Interaction (DDI)
The purpose of this modeling effort was to explore the effects of various processes and physiological parameters on the DDI involving competitive and time-dependent inhibition (TDI). Absorption and…