In the past, the company’s software has been used a great deal by the FDA in support of research for several divisions, such as the Office of Generic Drugs, the Center for Food Safety and Applied Nutrition, and the Center for Veterinary Medicine. Several licenses of GastroPlus will now be exclusively available for scientists in the Office of Clinical Pharmacology (OCP), a division that is responsible for analyzing clinical data with emphasis on studying population variability (in both healthy and patient subject groups) and drug-drug interactions. It is becoming more widespread to use physiologically based pharmacokinetic (PBPK) modeling to assist with different facets of clinical research, and the industry-leading capabilities of GastroPlus will be applied by the OCP in these areas.
The company’s simulation technologies group will host a GastroPlus workshop for OCP scientists in the near future; more than 35 have already confirmed their attendance. They will be trained on using the software, and Simulations Plus will gather information about how the software can be improved to help the OCP in its recent initiative to incorporate modeling and simulation in evaluating and approving new medicines.
For more information, visit www.simulations-plus.com
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