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Q&A from Adaptive Trial Simulation session

PML TSE Adaptive Trial

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#1 bwendt@certara.com

bwendt@certara.com

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Posted 20 December 2017 - 08:46 AM

Q: How to define ABEC?

 

A: ABEC is defined as the Area between Baseline and Effect Curve. It is a common summary parameter for indirect response models that best characterizes the overall effect of the drug. You can calculate ABEC simply by subtracting the baseline value that is given by Kin over Kout from the predicted Effect value, e.g. ABEC = E -  Kin/Kout

 

Q: When will Trial Simulator Engine be released in Phoenix?

 

A: As mentioned in the webinar, Trial Simulator Engine will be released in the Certara Portal in January 2018. Implementation of the functionality in Phoenix is planned but no release dates have been scheduled.

 

Q: ­Can you explain the difference between TSE and the new nlmixR package in R?­

 

A: While TSE is a stand-alone clinical trial simulation tool,  supporting real-world trial simulations using a flexible and simple programming language (PML) that is common to Phoenix NLME,

nlmixR package is a model fitting tool, please see http://nlmixr.org/wp...oducing-nlmixr/ for details.

 

Q: ­What happened to the Clinical Trial Simulator?  That was quite a good program?­

 

A: Clinical Trial Simulator is a software that is still available from Certara.

 

Q: ­Is sleep(1) the only way to specify sampling interval?  Can you specify arbitrary sampling times?­

 

A: The sleep statement causes its procedure to cease executing for a length of simulated time, which is specified by its argument. So it can be used to specify arbitrary sampling times. For example, the following procedure outputs the variable C1Obs (a variable in model pk) at times 0, 0.5, 1, 2, 4  and 8.

sproc obs_central_comp(){

                sleep(0)

                observe(pk$C1Obs)

                # observation at 0.5

                sleep(0.5)

                observe(pk$C1Obs)

                # observation at 1

                sleep(0.5)

                observe(pk$C1Obs)       

                # observation at 2 

                sleep(1)

                observe(pk$C1Obs)       

                # observation at 4

                sleep(2)

                observe(pk$C1Obs)       

                # observation at 8

                sleep(4)

                observe(pk$C1Obs)       

}

 

Q: ­This is the great tool. Can we please have the R script posted in the PML forum?

 

A: As usual, we will post all materials to the User Forum at:

https://support.cert.../34-pml-school/

This will include the slide deck, the project file, the scripts, the model file as well as a link to the recorded session.

 

Q:  Do we have some more webinars on this feature taking few examples further?­

 

A: As indicated on one of the slides, there will be an Introductory Program for Trial Simulator Engine that includes free training webinar sessions. If you are interested please send an email 







Also tagged with one or more of these keywords: PML, TSE, Adaptive Trial

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