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  • [NMusers] NONMEM bug XV correction to NONMEM bug list [23MAY2005] --> revised 18July2005
    to NONMEM bug list 23MAY2005 revised 18July2005 Date Mon July 18 2005 3 24 pm Replace the statements in NONMEM bug XV READ UNITC NDI SIZE0 SIZE1 SIZE2 NBLK IWRITE NREC KK NDI with READ UNITC NDIX SIZE0 SIZE1 SIZE2 NBLK IWRITE NREC KK NDIX Corrected buglist can be found at ftp ftp globomaxnm com Public nonmem buglist NONMEMbugs23MAY2005revised18July2005 pdf or http www globomaxservice com products NONMEMbugs23MAY2005revised18July2005 pdf nmconsult globomaxnm

    Original URL path: http://nonmem.org/nonmem/nm/99jul182005.html (2016-04-25)
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  • [NMusers] End of semester MCQ and short answer question
    vivo bioavailability or bioequivalence study a The analytical method used in an in vivo bioavailability or bioequivalence study to measure the concentration of the active drug ingredient or therapeutic moiety or its active metabolite s in body fluids or excretory products or the method used to measure an acute pharmacological effect shall be demonstrated to be accurate and of sufficient sensitivity to measure with appropriate precision the actual concentration of the active drug ingredient or therapeutic moiety or its active metabolite s achieved in the body There is a 2001 Bioanalytical Method Validation guidance that defines LLOQ as concentrations with 20 CV http www fda gov cder guidance 4252fnl pdf It says nothing that I can see about whether LLOQ should be applied when doing a PK analysis Note that Bioanalytical Method validation statistics such as LLOQ are used to describe the properties of the assay This guidance does not define how the concentrations are to be used A subsequent 2003 Bioavailability and Bioequivalence document describes PK procedures but does not mention the use of LLOQ http www fda gov cder guidance 5356fnl pdf There seems to be a common mis perception that FDA requires the use of LLOQ in a PK analysis however no one has provided any written evidence of this policy so far My interpretation of these responses is that the closest answer to Q1 should be d Using the actual measurement i e ask the chemical analyst to tell the truth Question 2 Almost full marks to the nmusers peson who gave a list of references of various opinions on dealing with BLQ values Some credit was lost for using an obscure Latex grin character based formatting convention and providing a non retrievable reference to recent work attributed to M Tod A prominent user of NONMEM responded The only advances have been I my increasing conviction that whenever the pattern of BLQ values is consistent with the observed PK that a ignoring BLQ values along with the adjustment described by Beal 2001 to account for the bias is the way to go and II the addition of a feature in NONMEM version VI that allows this sort of thing to be easily done Nick From Leonid Gibiansky leonidg metrumrg com Subject Re NMusers End of semester MCQ and short answer question Date Sun July 17 2005 12 26 pm Nick Your option d Using the actual measurement i e ask the chemical analyst to tell the truth should help to limit LLOQ somehow but at the end you will still get some zero values that are measurements below LLOAATDCFZ lower limit of assay ability to distinguish concentration from zero Then you will need to choose among 3 other options a Ignoring 0 values b Using 0 values as 0 c Imputing 0 values as 0 5 LLOAATDCFZ Remembering the advice of a prominent user of NONMEM I am not sure whether this is the same user as your adviser but I found on more than one

    Original URL path: http://nonmem.org/nonmem/nm/99jul142005.html (2016-04-25)
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  • [NMusers] Journals
    July 15 2005 12 07 am Hi all I have had a few responses to my question regarding the top 5 Journals I was hoping to get a few more to get a better reflection on what our group considers to be the best 5 Part of the reason for this request is that some of the Journals that we publish in have very low impact factors despite being what we consider high quality Journals This low impact factor is viewed by others outside of our area as reflecting poor quality work My hope is to get objective evidence from the experts in our area i e the recipients of this email about what they consider top Journals are in our field Please send your response to me and I am grateful for your time Steve From sduffull pharmacy uq edu au Subject RE NMusers Journals Date Tue July 19 2005 7 15 am Hi all Thanks to everyone who responded to the impromptu survey Overall I received 22 responses from NMUsers which is actually quite a reasonable number since I am guessing that only 1 person from a particular group would have responded so this could equate to responses from 22 M S groups somewhat of an assumption Below are the summary characteristics I evaluated the responses from two viewpoints 1 The proportion of times that any particular Journal was listed in the top 5 and 2 a ranking score for the Journal The ranking was evaluated as the sum of the ranks for each Journal over the responses that provided a ranked list such that First place 5 Second place 4 Third place 3 Fourth place 2 Fifth place 1 Not placed 0 There were 14 responses where the rank of the Journal could be assessed The maximum

    Original URL path: http://nonmem.org/nonmem/nm/99jul122005.html (2016-04-25)
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  • [NMusers] new contact information (phone and snail mail) for nmconsult
    for nmconsult Date Tue 5 Jul 2005 13 44 15 0400 The GloboMax division of ICON has moved to a new location The contact information for nmconsult is as follows mail GloboMax a Division of ICON 6031 University Blvd Suite 300 Ellicott City MD 21043 Attn nmconsult phone 410 696 3098 fax 410 480 0776 email nmconsult globomaxnm com same as before William J Bachman Ph D Manager Pharmacometrics Research

    Original URL path: http://nonmem.org/nonmem/nm/97jul052005.html (2016-04-25)
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  • [NMusers] guideline on data exclusion?
    com Subject NMusers guideline on data exclusion Date Tue July 5 2005 11 09 pm Dear users I am working on a dataset with many typos mislabels and several obvious outliers Is there a guideline that I can follow to

    Original URL path: http://nonmem.org/nonmem/nm/98jul052005.html (2016-04-25)
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  • [NMusers] statistical basis of NONMEM
    still looking for any avalaible information Thank you Julien From Bachman William MYD bachmanw iconus com Subject RE NMusers statistical basis of NONMEM Date Tue July 5 2005 12 51 pm You should have received a list of references abstracts and application papers with your NONMEM manuals and distribution media Check with your internal contact From Bonate Peter Peter Bonate genzyme com Subject RE NMusers statistical basis of NONMEM Date

    Original URL path: http://nonmem.org/nonmem/nm/99jul052005.html (2016-04-25)
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  • [NMusers] Model selection criteria?
    PAGE If the goal is to identify sources of between subject variability BSV which might be helpful in predicting doses in individuals then you might want to look at how much the estimated BSV is reduced e g Matthews et al 2004 In most cases I rely on changes in objective function to find the model that gives the best overall fit then use graphical methods to confirm that the predictions make sense Any reduction in OBJ means a better fit but not necessarily a better model for the intended purpose see above There are hypothesis testing criteria based on the change in OBJ but these are usually not of much interest in themselves because modellers aren t typically interested in P values If you really want to know the P value associated with a given change in OBJ it can take quite a bit of work to get a reliable estimate e g http wfn sourceforge net wfnrt htm In most cases if you use the FOCE estimation method you can reasonably assume changes in OBJ are approximately chi squared distributed to get an idea of the Type I error The AIC and SC are not typically used by the NONMEM community for model selection This is in part because there is no easy way to obtain the WRSS term but also because the change in objective function is easily obtained and gives almost the same kind of information Precision of a parameter estimate might be a model selection criterion if you the purpose of modelling is to estimate a particular parameter with less than some degree of uncertainty I think this is a very rarely applied purpose of modelling but if you do it then you should not rely on NONMEM s standard error estimates to compute confidence

    Original URL path: http://nonmem.org/nonmem/nm/99jul012005.html (2016-04-25)
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  • [NMusers] POSTHOC and ETA values disagree
    I split the PK and PD estimations What might cause all individual POSTHOC values to be exactly the same while the corresponding ETA value might be some large value What might cause a gradient for an ETA to be zero I am estimating PD parameters from 6 individuals and about 2500 total data points Individual fits work just fine with an expected degree of variation in the parameters The model parameters I find from individual fits are THETA 1 THETA 2 THETA 3 THETA 4 THETA 5 THETA 5 1 17E 01 1 22E 03 4 90E 00 1 26E 02 9 33E 02 9 62E 01 1 47E 01 1 44E 03 4 64E 00 2 82E 03 3 56E 02 1 00E 02 1 36E 01 1 74E 03 4 76E 00 4 38E 03 7 05E 02 9 71E 01 1 02E 01 1 28E 03 3 41E 00 6 81E 03 7 99E 02 9 97E 01 2 09E 01 1 60E 03 3 96E 00 1 22E 02 6 20E 01 9 82E 01 1 69E 01 1 86E 03 5 80E 00 6 39E 03 1 07E 01 1 03E 02 When I do

    Original URL path: http://nonmem.org/nonmem/nm/99jun292005.html (2016-04-25)
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