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FDA Purchasing Additional Generic Drug Simulation Software for Scientists–Faster and More Efficient Than Physically Dissol

Posted Aug 13 2010 6:52pm

The FDA is not alone in their thinking here either as earlier this year Bill Gates invested in drug simulation software too.  According to the press release an additional 10 licenses were purchased.  image

In addition the company mentions a training course upcoming for the FDA scientists relating to their GastroPlus software. 

From the Website: image

“GastroPlus is an advanced software program that simulates the absorption, pharmacokinetics, and pharmacodynamics for drugs in human and preclinical species. The underlying model is the Advanced Compartmental Absorption and Transit (ACAT) model. Since 1997, Simulations Plus has evolved the ACAT model to a high state of refinement, providing the industry's most accurate, flexible, and powerful simulation program. This smoothly integrated platform combines a user-friendly interface with sophisticated science to help you make better project decisions... faster!”

In order to approve and research a a drug they scientists need to know how it is going to dissolve.  The additional licenses purchased are for the DDDPlus software which allows for the creation of formulation data bases and simulate predictions for the drug. 

Back in the beginning of 2008 the FDA said they were boosting IT and this shows a heavier use of technology as just only 2-3 years ago not all had computers and some were still writing up studies in long hand.  The next plateau is to hire some coder and programmers so they have some in house and not rely on outside businesses as heavily as competition is sometimes getting a little in the way at times along with marketing on steroids today.  BD

LANCASTER, Calif.--( BUSINESS WIRE )-- Simulations Plus, Inc. (NASDAQ: SLP), a leading provider of software for pharmaceutical discovery and development, today announced that it has received a purchase order from the U.S. Food and Drug Administration to expand the number of licenses for the Company’s DDDPlus™ simulation software.

John DiBella, director of marketing and sales for Simulations Plus, said: “This purchase will add 10 more licenses for our DDDPlus software to those already held by the Office of Generic Drugs. DDDPlus is a unique program that simulates in vitro (laboratory) dissolution experiments, thereby enabling formulation scientists to better assess the effects of changing formulation variables such as the size of the drug particles and the amount of various excipients, as well as experimental parameters such as the composition of the fluid and the speed of agitation (stirring).

Such simulations can provide agency scientists with valuable insight into the dissolution of generic formulations compared to innovator formulations when generic drug companies submit abbreviated new drug applications (ANDAs) to the agency. Another use is to assess how changing the experiment might provide greater discrimination between the dissolution rates of different formulations. Some experimental conditions might show little difference in dissolution rate, while others might amplify the differences more effectively. It’s faster and less expensive to simulate the dissolution process than to physically dissolve tablets, make measurements, analyze the data, and clean up the lab. Once the experimental parameters have been identified, real experiments can be run to confirm the predictions.” image

Dr. Michael Bolger and I will be at the FDA offices in Maryland next week to train 30 more scientists in the use of our GastroPlus™ software. FDA scientists are among the elite in the world of pharmaceutical science, so their selection of Simulations Plus software is extremely satisfying to our scientists, management, and shareholders.”

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