Clinical Trial Simulation

Population PK/PD modeling has been used successfully for numerous drugs. These models may be descriptive and/or predictive of the time course of PD effects. When properly developed, predictive models may be used to guide starting doses and regimens (as well as adjustments of dosage and dosing regimens in special populations), add evidence to the certainty of the decision to allow market access, and provide a better understanding of outcomes from clinical studies [23,24]. Clinical trial simulations are usually motivated as follows:

• To improve the clinical trial process by maximizing the probability of trial objectives being attained with reduction of unnecessary costs

• To improve decision making in drug development by providing an objective framework for safety, efficacy, and commercial risk assessments

• To improve the overall efficiency of drug development in terms of infor-mativeness, economy, and speed

Modeling and simulation may help predict the results of future drug trials and can be used at decision points in the drug development process to assess quantitatively the risk of moving forward with a candidate drug.

Project Management Made Easy

Project Management Made Easy

What you need to know about… Project Management Made Easy! Project management consists of more than just a large building project and can encompass small projects as well. No matter what the size of your project, you need to have some sort of project management. How you manage your project has everything to do with its outcome.

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