[NMusers] RE: Link different thetas to same omega using mu referencing

2016-04-13 Thread Michael Fossler
This looks like it would work - it seems to obey the rules around mu-referencing. You can simplify the $OMEGA by using SAME(3) Mike Michael J. Fossler, Pharm. D., Ph. D., F.C.P. VP, Quantitative Sciences Trevena, Inc mfoss...@trevenainc.com Office: 610-354-8840, e

RE: [NMusers] unbalanced data set

2016-01-06 Thread Michael Fossler
At the risk of being tiresome about this topic, absent specific differences between Phase 1 and Phase 2/3 data , e.g., renal function due to age or disease states, etc., I'd argue that most of the differences seen between Phase 1 and Phase 2/3 data are due to adherence. In a sense, then, much of

Re: [NMusers] Re: Weight based dosing

2015-12-08 Thread Michael Fossler
While it is important to look at the variability explained by the covariate, your question is not really a statistical one. You need to evaluate the clinical significance of the change in exposure by weight. For a given dose, how does exposure change by weight and how will this affect the effica

Re: [NMusers] Question of fitting population PK model using summary statistics of data instead of raw data

2015-09-10 Thread Michael Fossler
I would argue that it is impossible. With mean data and SD's at each time-point, it is impossible to separate between and with-subject variability. However, a model with "strong assumptions", as Leonid has aptly put it, may still be very useful. It should not be too difficult to come up with reas

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

2015-06-23 Thread Michael Fossler
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 mfoss...@trevenainc.com Office: 610-354-8840, ext.

RE: [NMusers] Covariate modelling question

2015-02-26 Thread Michael Fossler
you have just described: a large, overly-complex model. Regardless of the technical details, if you can’t see a pattern in the residual plots with regard to a given covariate, it is unlikely to provide any meaningful reduction in the residual error of your parameter model. Michael Fossler

[NMusers] RE: SAEM/IMP best practices

2013-11-11 Thread Michael Fossler
d use less stringent termination criteria (e.g., CTYPE=1, CALPHA=0.01). Looking at your SAEM code, I would increase your NITER to at least 2000-3000 if ISAMPLE=2. Michael Fossler, Pharm.D., Ph.D., F.C.P. Senior Director, CPMS CPMS - US RD Projects Clinical Platforms & Sciences GSK Upper Me

[NMusers] Duane Boyle Memorial Trust

2011-11-14 Thread Michael Fossler
On November 5, 2011, GSK lost one of its best scientists, Duane Boyle, following an 18 month battle with cancer. Duane earned a BS in pharmacy from the University of Wisconsin in 1982 and a doctor of pharmacy degree from the University of Texas (Austin) in 1985. After completing a post-doctor

RE: [NMusers] Table formatting in NONMEM7- can I skip the "Table No." header row?

2011-05-17 Thread Michael Fossler
In R you don't need to worry about the "Table No. 1" if you use the "skip" argument of the read.csv() command. For example data<-data.frame(read.csv(paste(dir,run.name,".csv",sep=""),header=TRUE,sep=",",stringsAsFactors=F,skip=1)) using skip=1 as above will cause R to jump over the first line

RE: [NMusers] Does inter-CPU variability exist in NONMEM??

2011-02-17 Thread Michael Fossler
I believe that there is some literature around this topic. Once, when running a model on a Solaris cluster, I could not get it to converge, where the exact same code/data on a PC did converge. Like Kevin, I suspect it is due to differences in how the CPUs handle significant figures. This is so

RE: [NMusers] variances on PK parameters

2011-01-17 Thread Michael Fossler
Hi Bei; You will not be able to estimate variances with n=3. I suggest that you fit each dog separately. -Original Message- From: owner-nmus...@globomaxnm.com [mailto:owner-nmus...@globomaxnm.com] On Behalf Of Bei Yang Sent: Monday, January 17, 2011 1:57 PM To: nmusers@globomaxnm.com

RE: [NMusers] outsourcing PK/PD analysis - help wanted

2011-01-06 Thread Michael Fossler
As President of the American College of Clinical Pharmacology, I am pleased to point out that the Journal of Clinical Pharmacology (our flagship publication) has excellent advertiser rates, and would be pleased to host information about any of these fine CRO’s, which will be read by drug develo

RE: [NMusers] distribution assumption of Eta in NONMEM

2010-05-31 Thread Michael Fossler
Interesting topic. Can anyone provide specific transformations of ETAs that they have found useful? Mike Fossler GSK -Original Message- From: owner-nmus...@globomaxnm.com [mailto:owner-nmus...@globomaxnm.com] On Behalf Of Leonid Gibiansky Sent: Monday, May 31, 2010 5:31 PM To: Nick Ho