Dennis,
I may have to disagree, a little. There is information, a little, in a pre dose 
BQL, about assay precision. I think you might agree that is a pre dose sample 
is NOT BQL (which happens), tells you (and NONMEM) something about the assay. 
Converse, even a BQL predose sample has a small amount of information.
That not withstanding, we also remove and pre-dose BQLs from the data set.


Mark Sale M.D.
Senior Vice President, Pharmacometrics
Nuventra Inc.
2525 Meridian Parkway, Suite 200
Durham, NC 27713
Phone (919)-973-0383
ms...@nuventra.com<ms...@kinetigen.com>


CONFIDENTIALITY NOTICE The information in this transmittal (including 
attachments, if any) may be privileged and confidential and is intended only 
for the recipient(s) listed above. Any review, use, disclosure, distribution or 
copying of this transmittal, in any form, is prohibited except by or on behalf 
of the intended recipient(s). If you have received this transmittal in error, 
please notify me immediately by reply email and destroy all copies of the 
transmittal.

________________________________
From: owner-nmus...@globomaxnm.com <owner-nmus...@globomaxnm.com> on behalf of 
Dennis Fisher <fis...@plessthan.com>
Sent: Wednesday, November 6, 2019 7:23 AM
To: nmusers@globomaxnm.com <nmusers@globomaxnm.com>; Bill Denney 
<wden...@humanpredictions.com>
Cc: Carlos ST <carlos.serr...@gmail.com>; Steven Shafer 
<steven.sha...@stanford.edu>
Subject: Re: [NMusers] Using evid 0 before dosing


WARNING: This email originated from outside of the company. Do not click links 
or open attachments unless you recognize the sender and are expecting the 
message.

Bill

I think that the issue is more complicated than you acknowledge.

Assuming that the drug is not an endogenous substance, the pre-dose 
concentration is likely to be BQL.  However, there are two kinds of BQL values:
1.  Samples that are truly zero because they were obtained pre-dose
2.  Samples that are > 0 but < LOQ.
Yet both are reported as BQL.

>From my perspective, a BQL value pre-dose provides no information to NONMEM.  
>Therefore, one should apply EVID=2 to that sample.  This allows a prediction 
>at that timepoint but the sample does not influence the analysis.

Dennis

Dennis Fisher MD
P < (The "P Less Than" Company)
Phone / Fax: 1-866-PLessThan (1-866-753-7784)
www.PLessThan.com<http://www.plessthan.com/>




On Nov 6, 2019, at 7:12 AM, Bill Denney 
<wden...@humanpredictions.com<mailto:wden...@humanpredictions.com>> wrote:

Hi Carlos,

It is commonly used.  For most datasets, there will be at least one
observation that occurs before dosing to estimate the baseline value, and in
almost every scenario, the modeling dataset should mirror the real world
actions.  So, there is no issue with it, and usually you will have an EVID=0
before the first dose.

Thanks,

Bill

-----Original Message-----
From: owner-nmus...@globomaxnm.com<mailto:owner-nmus...@globomaxnm.com> 
<owner-nmus...@globomaxnm.com<mailto:owner-nmus...@globomaxnm.com>> On Behalf
Of Carlos ST
Sent: Wednesday, November 6, 2019 10:03 AM
To: nmusers@globomaxnm.com<mailto:nmusers@globomaxnm.com>
Subject: [NMusers] Using evid 0 before dosing

Dear NMUsers,

I would like advice in the best practice to use evid 0 before dosing, which
is to say an observation just before a dosing (*to estimate the value in
that compartment just before dosing event).

Thank you,

Carlos,


Reply via email to