Simulate clinical trial

For instance, I developed an R script that computes the target attainment rate for subjects based on their meropenem concentrations. One of the most powerful aspects of trial simulation is that you can test multiple scenarios with regard to your assumptions, the drug and disease model, and aspects of the trial design. Here is a plot showing the target attainment rates for four different degrees of fluid retention for patients in each age group. The columns are the various age categories.

For ages five and up, the subjects show high rates of target attainment, especially for the TID administration and the P40 target. But for younger age groups, particularly for the BID administration, attainment rates are markedly lower. Thus, we can conclude that for younger patients, we likely need to give higher doses to achieve adequate drug exposure. Featured Product. Simcyp: 20 Years of Innovation.

Contact Investors Careers Support. Thu, January 24th Blog. Contact Us. About the author By: Mark Lovern. Recommended for you. In vitro in vivo correlation IVIVC is a predictive mathematical model that describes the relationship between an in vitro property of a dosage formulation and a relevant in vivo exposure. IVIVC expresses the relationship between drug release in a dissolution apparatus and how that translates to the amount of drug that enters the bloodstream following administration.

In this case, the dissolution test serves as a surrogate for human BE studies when there are manufacturing process or site changes post-approval. IVIVC can also help pick the best modified release formulation for progression.

A Level A relationship is required to waive BE studies for a modified release product. This is generally a point-to-point relationship between in vitro dissolution and the in vivo input rate. Data from clinical BA studies are required to establish this relationship, typically from cross-over studies in the fasted state utilizing at least 2 different formulations one fast releasing formulation and one slow releasing formulation.

IVIVC may be sufficient for biowaivers for:. The goal of a clinical trial simulation is to study the effect of a drug in a virtual patient population to help understand the likelihood of clinical impact of some unknown factor such as, recruitment issues, dropout rate, treatment effect, etc. The idea is to be able to increase the efficiency across all stages of clinical development for factors such as:. Recently the FDA and EMA have both included modeling and simulation among their highest priorities to support efficient drug development and facilitate regulatory decision making.

Modeling and simulation can and should be applied throughout all stages of development. There are many opportunities for conducting more efficient trials or avoiding additional trials altogether. Our team can create a custom, model informed drug development MIDD plan that will facilitate the selection of the optimal model for your compound and disease area. Download Blog as PDF. Modeling and simulation can be used in many different types of situations, such as: Predicting the optimal dose in adult patients from Phase and in the product label Designing Phase clinical trials Assessing the probability that a new compound will have better efficacy or safety compared to the gold standard Predicting the dose in patient subgroups e.

Modeling for Labeled Dose Not Directly Tested in a Clinical Trial Modeling and simulation can directly impact the drug label, even as far as labeling for dose regimens that were not directly tested in clinical studies.

Leveraging existing knowledge for a drug under study with simulation, you can find answers to critical questions to increase your probability of meeting study endpoints. Access existing scientific knowledge and test ideas and plan effective trials with Trial Simulator:.

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