Collaboration with the US FDA and Center for Research on Complex Generics to Establish the Suitability of Model-Integrated Evidence to Demonstrate Bioequivalence for Long-Acting Injectables

Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation solutions for the pharmaceutical and biotechnology industries, today announced the completion of a newly funded project from the U.S. Food and Drug Administration (FDA) and the Center for Research on Complex Generics (CRCG), through a collaboration of its Lixoft and Cognigen divisions, to establish the suitability of model-integrated evidence to demonstrate bioequivalence (BE) for long-acting injectable (LAI) and implantable drug products.

For this project, a novel model-integrated design for bioequivalence studies of LAI products was proposed by the scientific team at Simulations Plus with the MonolixSuite complete framework. To alleviate the low power or long duration of bioequivalence trials for long-acting injectables (LAIs), Simulations Plus proposed a novel two-treatment, two-period, one-sequence “reduced crossover” design with no or limited washout, combined with a model-based correction of the data of the second period. Individual parameters were estimated based on the data of the first period (reference) and used to predict the carryover concentration into the second period, which is subtracted from the second period data before usual BE analysis. The results were presented at an FDA-sponsored workshop on Nov. 30, 2021.

Dr. Jonathan Chauvin, President of the Lixoft division at Simulations Plus, said: “Our efficient NCA calculation engine in PKanalix, with our cutting-edge PK/PD modeling approaches in Monolix and Simulx, were not used to support LAI previously, therefore this project was a great opportunity to show the need and relevance of the population modeling approach for LAI products and the bioequivalence calculations. The complete framework available in MonolixSuite shows the efficiency of our tools through its interoperability between applications and its flexibility to go from NCA and bioequivalence to population modeling and simulation. Finally, it is a notable achievement to deliver a joint solution to this challenge via the global complementarity of the scientific teams in each division at Simulations Plus.”

Jill Fiedler-Kelly, President of the Cognigen division of Simulations Plus, added: “This project was a great demonstration of the synergistic combination of the scientific expertise and innovative capabilities of our teams; in particular, lead investigator Géraldine (Ayral) Cellière, and the excellent software tools of Simulations Plus. We are thrilled to have contributed to the development of a novel solution to this challenging problem.”

About Simulations Plus

Serving clients worldwide for 25 years, Simulations Plus is a leading provider in the biosimulation market providing software and consulting services supporting drug discovery, development, research, and regulatory submissions. We offer solutions that bridge machine learning, physiologically based pharmacokinetics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. Our technology is licensed and applied by major pharmaceutical, biotechnology, and regulatory agencies worldwide. For more information, visit our website at www.simulations-plus.com. Follow us on LinkedIn | Twitter | YouTube.

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