By integrating in vitro and preclinical in vivo data, GastroPlus helps scientists select optimal doses for first-in-human trials, reducing the risk of failure and ensuring safety margins are maintained.
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The software includes modules to simulate pharmacokinetics in special populations, such as pediatric patients, pregnant women, and patients with renal or hepatic impairment. This is critical for designing safe and effective clinical trials for demographics that are difficult to study directly. By integrating in vitro and preclinical in vivo
: For generics, it assists in demonstrating bioequivalence between the generic product and the reference listed drug. : Users can input data on drug formulations,
: Users can input data on drug formulations, such as tablets or capsules, and the software can predict how changes in formulation affect drug performance.