RE: simulation of dose escalation study

From: "Leonid Gibiansky" leonidg@metrumrg.com Subject: RE: [NMusers] simulation of dose escalation study Date: Fri, April 15, 2005 9:29 am Anthe, Design of the study is not completely clear from your e-mail (whether you do escalation for all 20 volunteers or you block them by cohorts) and I have not tested it before but: you may be able to do it using $ABBREV COMRES= option. COMRES allows you to store and use global variables that are transfered from one time to the next one and from the volunteer to the next volunteer. Using few COM(.) variables, you may be able to create an indicator whether previous volunteer had adverse event (and the next dose should be equal to the previous one) or dose needs to be increased. Dose increase can be done via bioavailability parameter F. In your data file you assign initial (equal) doses for all 20 patients but increase F if needed (if COMRES-stored variables dictate you to do so). The control stream / data file should describe a study of 20 volunteers. The you can use SUBPROBLEMS=200 options to repeat it 200 times. Leonid