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To increase the efficiency of trials in drug development, optimal experimental design has been used to successfully optimize dose allocation and sampling schedules. Better incremental decisions in Phase I and II result in greater likelihood that the safety and efficacy of the right dose is being studied, for the right indication and in the right patient population. This approach involves a pre-planned adaptation of aspects of study design based on statistical and/or pharmacokinetic/pharmacodynamic (PK/PD) analysis. From a modelling and simulation (M&S) perspective, a prior understanding of concentration (dose)-efficacy and of concentration (dose)-toxicity relationship is needed.

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Real time implementation of the software system requires being more versatile. In the maintenance phase, the modified system under regression testing must assure that the existing system remains defect free. Test case prioritization technique of regression testing includes code as well as model based methods of prioritizing the test cases. System model based test case prioritization can detect the severe faults early as compare to the code based test case prioritization. Model based prioritization techniques based on requirements in a cost effective manner has not been taken for study so far. Model based testing used to test the functionality of the software system based on requirement. An effective model based approach is defined for prioritizing test cases and to generate the effective test sequence. The test cases are rescheduled based on requirement analysis and user view analysis. With the use of weighted approach the overall cost is estimated to test the functionality of the model elements. Here, the genetic approach has been applied to generate efficient test path. The regression cost in terms of effort has been reduced under model based prioritization approach.

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The use of Adaptive designs is becoming quite popular and well-perceived by the regulatory agencies such as the FDA in the US. “Adaptation” can occur in different fashion and potentially make studies more efficient (e.g. shorter duration, fewer patients) more likely to demonstrate an effect of the drug if one exists, or more informative (see “Adaptive Design Clinical Trials for Drugs and Biologics” FDA guidance). The aim of this presentation is to illustrate a case where an adaptive design was used in a Phase III oncology pivotal study having Overall Survival as a primary end-point. The particular adaptation implemented was an un-blinded SSR that applied a promising zone approach. The main focus will be how the adaptive design impacted the SDTM modelling, the design of some ADaM datasets (e.g. those containing the time-to-event endpoints and therefore using ADTTE ADaM model) and later on how some mapping and analysis decisions were described in both the study and analysis reviewer guide.

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