Simulations Plus Receives New FDA Grant Award
Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemicals, and consumer goods industries, today announced it has been awarded a new funded grant from the U.S. Food and Drug Administration (FDA).
- Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemicals, and consumer goods industries, today announced it has been awarded a new funded grant from the U.S. Food and Drug Administration (FDA).
- The grant will be used to validate and define best practices for physiologically based biopharmaceutics/pharmacokinetics (PBBM/PBPK) modeling workflows to simulate virtual bioequivalence (VBE) studies in support of regulatory biowaivers.
- The scientific team at Simulations Plus, with partners from the FDA, industry, and academia, will apply public and proprietary datasets to validate the ability of GastroPlus® and other software to predict inter- and intra-subject variability when performing virtual population simulations.
- Dr. Martins, with assistance from Simulations Plus colleagues Dr. Maxime Le Merdy , Dr. Géraldine Cellière , and Mr. James Mullin , will coordinate all activities of the award.