Simulo: a new service for drug trial simulation

4 messages 4 people Latest: Jun 23, 2015
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 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 E-mail: [email protected]<mailto:[email protected]> Web: http://www.exprimo.com/ Information in this email and any attachments is confidential and intended solely for the use of the individual(s) to whom it is addressed or otherwise directed. Please note that any views or opinions presented in this email are solely those of the author and do not necessarily represent those of the Company. Finally, the recipient should check this email and any attachments for the presence of viruses. The Company accepts no liability for any damage caused by any virus transmitted by this email. All SGS services are rendered in accordance with the applicable SGS conditions of service available on request and accessible at http://www.sgs.com/en/Terms-and-Conditions.aspx
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
Quoted reply history
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 > > E-mail: > > [email protected] <mailto:[email protected]>_ > > Web: > > www.exprimo.com http://www.exprimo.com/ > > Information in this email and any attachments is confidential and > intended solely for the use of the individual(s) to whom it is addressed > or otherwise directed. Please note that any views or opinions presented > in this email are solely those of the author and do not necessarily > represent those of the Company. Finally, the recipient should check this > email and any attachments for the presence of viruses. The Company > accepts no liability for any damage caused by any virus transmitted by > this email. All SGS services are rendered in accordance with the > applicable SGS conditions of service available on request and accessible > at http://www.sgs.com/en/Terms-and-Conditions.aspx
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/
Quoted reply history
-----Original Message----- From: [email protected] [mailto:[email protected]] On Behalf Of Leonid Gibiansky Sent: Tuesday, June 23, 2015 4:14 PM To: Faelens, Ruben (Belgium); [email protected] 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 > > > > > > > > > > > > > > > > > > > > E-mail: > > > > [email protected] <mailto:[email protected]>_ > > > > > > > > > > > > > > > > > > > > Web: > > > > www.exprimo.com http://www.exprimo.com/ > > > > > > > > > > > > > > > > > > > > Information in this email and any attachments is confidential and > intended solely for the use of the individual(s) to whom it is > addressed or otherwise directed. Please note that any views or > opinions presented in this email are solely those of the author and do > not necessarily represent those of the Company. Finally, the recipient > should check this email and any attachments for the presence of > viruses. The Company accepts no liability for any damage caused by any > virus transmitted by this email. All SGS services are rendered in > accordance with the applicable SGS conditions of service available on > request and accessible at > http://www.sgs.com/en/Terms-and-Conditions.aspx
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 [email protected] Office: 610-354-8840, ext. 249 Cell: 610-329-6636
Quoted reply history
-----Original Message----- From: [email protected] [mailto:[email protected]] On Behalf Of Mats Karlsson Sent: Tuesday, June 23, 2015 12:06 PM To: Leonid Gibiansky; Faelens, Ruben (Belgium); [email protected] 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: [email protected] [mailto:[email protected]] On Behalf Of Leonid Gibiansky Sent: Tuesday, June 23, 2015 4:14 PM To: Faelens, Ruben (Belgium); [email protected] 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 > > > > > > > > > > > > > > > > > > > > E-mail: > > > > [email protected] <mailto:[email protected]>_ > > > > > > > > > > > > > > > > > > > > Web: > > > > www.exprimo.com http://www.exprimo.com/ > > > > > > > > > > > > > > > > > > > > Information in this email and any attachments is confidential and > intended solely for the use of the individual(s) to whom it is > addressed or otherwise directed. Please note that any views or > opinions presented in this email are solely those of the author and do > not necessarily represent those of the Company. Finally, the recipient > should check this email and any attachments for the presence of > viruses. The Company accepts no liability for any damage caused by any > virus transmitted by this email. All SGS services are rendered in > accordance with the applicable SGS conditions of service available on > request and accessible at > http://www.sgs.com/en/Terms-and-Conditions.aspx ________________________________ Notice: This e-mail message, together with any attachments, contains information of Trevena, Inc., 1018 West 8th Avenue, King of Prussia, PA 19406, USA. This information may be confidential, proprietary, copyrighted and/or legally privileged. It is intended solely for use by the individual or entity named on this message. If you are not the intended recipient, and have received this message in error, please notify us immediately and delete it and any attachments from your system.