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Re: [NMusers] Simulo: a new service for drug trial simulation

From: Leonid Gibiansky <lgibiansky_at_quantpharm.com>
Date: Tue, 23 Jun 2015 14:42:43 -0400

This is a very basic code that will reduce bioavailability in half if
some PD effect (the output of the model) drops below 100

$ABB COMRES=1 ; space to save simulated PD

$PK
   IF(NEWIND.LT.2) COM(1)=0 ; for each subject, COM(1) starts from zero
   F1 = 1
   IF(COM(1).EQ.1) F1=0.5 ; if COM(1) = 1, this will set F1 to 1/2
$ERROR
   IPRED=Y ; this is PD measure that need to be above 100
   IF(IPRED.LT.100) COM(1)=1 ; if PD drops below 100 at any time, halve
future doses

Leonid


--------------------------------------
Leonid Gibiansky, Ph.D.
President, QuantPharm LLC
web: www.quantpharm.com
e-mail: LGibiansky at quantpharm.com
tel: (301) 767 5566



On 6/23/2015 2:30 PM, Michael Fossler wrote:
> Does anyone have an example of using Fn (bioavailability of compartment n) to do adaptive dosing simulations? I am not having much luck getting it to work.
>
>
> Mike
> Michael J. Fossler, Pharm. D., Ph. D., F.C.P.
> VP, Quantitative Sciences
> Trevena, Inc
> mfossler_at_trevenainc.com
> Office: 610-354-8840, ext. 249
> Cell: 610-329-6636
>
>
> -----Original Message-----
> From: owner-nmusers_at_globomaxnm.com [mailto:owner-nmusers_at_globomaxnm.com] On Behalf Of Mats Karlsson
> Sent: Tuesday, June 23, 2015 12:06 PM
> To: Leonid Gibiansky; Faelens, Ruben (Belgium); nmusers_at_globomaxnm.com
> Subject: RE: [NMusers] Simulo: a new service for drug trial simulation
>
> Hi,
>
> In many cases you don't even need to use $ABB COMRES to do response-adaptive designs, simulated response could just impact a bioavailability term (Fx) of the next dose(s) to indicate dose change. I'm sure that more complex response-adaptive designs could benefit from a dedicated software though.
>
> Best regards,
> Mats
>
>
> Mats Karlsson, PhD
> Professor of Pharmacometrics
>
> Dept of Pharmaceutical Biosciences
> Faculty of Pharmacy
> Uppsala University
> Box 591
> 75124 Uppsala
>
> Phone: +46 18 4714105
> Fax + 46 18 4714003
> www.farmbio.uu.se/research/researchgroups/pharmacometrics/
>
> -----Original Message-----
> From: owner-nmusers_at_globomaxnm.com [mailto:owner-nmusers_at_globomaxnm.com] On Behalf Of Leonid Gibiansky
> Sent: Tuesday, June 23, 2015 4:14 PM
> To: Faelens, Ruben (Belgium); nmusers_at_globomaxnm.com
> Subject: Re: [NMusers] Simulo: a new service for drug trial simulation
>
> Actually, nonmem can be used to simulate the response-based dose adaptation without iteratively rerunning your model, with single simulation (using $ABB COMRES functionality to pass simulated response to the dose-adjustment algorithm code), although it is indeed cumbersome
>
> Leonid
>
> --------------------------------------
> Leonid Gibiansky, Ph.D.
> President, QuantPharm LLC
> web: www.quantpharm.com
> e-mail: LGibiansky at quantpharm.com
> tel: (301) 767 5566
>
>
>
> On 6/23/2015 4:48 AM, Faelens, Ruben (Belgium) wrote:
>> Dear NONMEM users,
>>
>> We all know how difficult it is to simulate full drug trials using
>> NONMEM. It is often necessary to generate the full dosing scheme(s)
>> beforehand, and response-based dose adaptation requires iteratively
>> rerunning your model until you have the results you are happy with.
>>
>> At SGS Exprimo, we have been working for 4 years to develop a new
>> software that makes drug trial simulation much more straight-forward.
>> The software has been developed in collaboration with Roche and has
>> been used internally within SGS Exprimo for the last 2 years. We are
>> now presenting it to the public as a new consultancy service. You may
>> have seen us in Crete at PAGE 2015.
>>
>> We invite you to visit our website www.simulo.eu
>> <http://www.simulo.eu> or contact us directly to request an on-site
>> demo or web conference, or to ask any questions you may have.
>>
>> We look forward to hearing from you.
>>
>> Kind regards,
>>
>> Ruben Faelens for SGS Exprimo
>>
>> *Ruben Faelens, MSc*
>> *Life Science Services - Exprimo*
>> IT Scientist
>>
>> Phone:
>>
>>
>>
>> +32 494 06 72 59
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>> E-mail:
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>> _ruben.faelens_at_sgs.com <mailto:ruben.faelens_at_sgs.com>_
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>> www.exprimo.com <http://www.exprimo.com/>
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Received on Tue Jun 23 2015 - 14:42:43 EDT

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