(Source: Certara LP) Drug development is becoming more complex than ever. Regulatory agencies expect sponsors to consider a wide variety of intrinsic and extrinsic factors that could impact drug safety and efficacy. These factors include intrinsic variability― CYP metabolizer status, age, sex, renal/hepatic impairment ― as well as external variables― co-medications, food effects, smoker status, etc. Clinical trials alone simply cannot evaluate all potential scenarios. Using modeling and simulation to conduct virtual trials can help sponsors optimize the dosing strategy and label claims for their drug programs. In this blog post, I'll discuss how we used modeling and simulation to help a...
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