0.02%. Of the compounds which enter preclinical development, only 0.02% become an approved drug. At this stage, the ultimate goals are to identify appropriate dose levels for the First-in-Human (FIH) study and clinical formulation options as the compound (hopefully) progresses. You may be incorporating some in silico tools to help, but are you using a mechanistic, integrative solution to generate a complete picture? And, are you working with the right modeling & simulation experts to develop a coherent, successful strategy? If your goal is to make informed decisions and improve your chances for success as you head to the clinic, then it’s time to take a closer look at Simulations Plus.
01. discover
Get to the clinic confidently…
What do we offer?
Typically, the research focus at the preclinical stage centers around:
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Absorption, Distribution, Metabolism, and Excretion (ADME) testing
Imagine utilizing the industry’s top-rated QSAR (ADMET Predictor®) & PBPK (GastroPlus®) models, together, to build a complete PBPK model in animals to track exposure levels in plasma and tissues.
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Pharmacokinetic (PK)/pharmacodynamic (PD) relationships
Work with our experts in PK/PD modeling to define appropriate relationships between target tissue concentrations and efficacy to optimize dose for your FIH study.
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Formulation development
As you begin to test clinical formulation concepts, utilize our dissolution modeling technology (DDDPlus™) to identify the influence of different particle size distributions or excipients on the dissolution of the prototype formulations.
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Safety assessment and toxicology research
Use our toxicity predictions in ADMET Predictor to waive some of the tests required by health authorities to assess the potential hazards and safety risks associated with your compound (e.g., the REACH European regulation). And, bring in the GastroPlus PBPK modeling platform to determine the maximum tolerated dose earlier. Finally, our DILIsym® platform, when combined with in vitro data, can help give you insight into possible liver safety concerns well in advance of clinical trials and help with compound prioritization.
There are other milestones you’ll need to meet – e.g., easily and quickly generate validated (or, non-validated) Noncompartmental Analysis (NCA) reports using PKPlus™ for IND filings. Just be assured that we have the solutions and experts to get you where you need to go… with confidence.